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.jet-dropdown-arrow{left:15px;right:auto;}@media(min-width:768px){.elementor-1413 .elementor-element.elementor-element-d394276{width:30.013%;}.elementor-1413 .elementor-element.elementor-element-ca90e8c{width:36.653%;}}</style><div data-elementor-type="wp-post" data-elementor-id="1413" class="elementor elementor-1413"><section class="elementor-section elementor-top-section elementor-element elementor-element-6be66f2 elementor-section-full_width elementor-section-content-top elementor-section-height-default elementor-section-height-default" data-id="6be66f2" data-element_type="section" data-settings="{"jet_parallax_layout_list":[{"jet_parallax_layout_image":{"url":"","id":"","size":""},"_id":"d72bfaa","jet_parallax_layout_image_tablet":{"url":"","id":"","size":""},"jet_parallax_layout_image_mobile":{"url":"","id":"","size":""},"jet_parallax_layout_speed":{"unit":"%","size":50,"sizes":[]},"jet_parallax_layout_type":"scroll","jet_parallax_layout_z_index":"","jet_parallax_layout_bg_x":50,"jet_parallax_layout_bg_y":50,"jet_parallax_layout_bg_size":"auto","jet_parallax_layout_animation_prop":"transform","jet_parallax_layout_on":["desktop","tablet"],"jet_parallax_layout_direction":null,"jet_parallax_layout_fx_direction":null,"jet_parallax_layout_bg_x_tablet":"","jet_parallax_layout_bg_x_mobile":"","jet_parallax_layout_bg_y_tablet":"","jet_parallax_layout_bg_y_mobile":"","jet_parallax_layout_bg_size_tablet":"","jet_parallax_layout_bg_size_mobile":""}]}"><div class="elementor-container elementor-column-gap-default"><div class="elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-d394276" data-id="d394276" data-element_type="column"><div class="elementor-widget-wrap elementor-element-populated"><div class="elementor-element elementor-element-003521d elementor-widget elementor-widget-spacer" data-id="003521d" data-element_type="widget" data-widget_type="spacer.default"><div class="elementor-widget-container"><div class="elementor-spacer"><div class="elementor-spacer-inner"></div></div></div></div><div class="elementor-element elementor-element-6347580e elementor-widget elementor-widget-heading" data-id="6347580e" data-element_type="widget" data-widget_type="heading.default"><div class="elementor-widget-container"><h2 class="elementor-heading-title elementor-size-default">NASAL PRODUCTS</h2></div></div><div class="elementor-element elementor-element-b6f9f87 elementor-widget elementor-widget-jet-custom-menu" data-id="b6f9f87" data-element_type="widget" data-widget_type="jet-custom-menu.default"><div class="elementor-widget-container"><div class="menu-nasal-products-container"><div class="jet-custom-nav jet-custom-nav--dropdown-right-side jet-custom-nav--animation-fade"><div class="menu-item menu-item-type-post_type menu-item-object-page jet-custom-nav__item jet-custom-nav__item-1683"><a href="https://www.proveris.com/sprayview-measurement-systems/" class="jet-custom-nav__item-link"><span class="jet-menu-link-text"><span class="jet-custom-item-label top-level-label">SprayVIEW<sup>®</sup> Measurement Systems</span></span></a></div><div class="menu-item menu-item-type-post_type menu-item-object-page jet-custom-nav__item jet-custom-nav__item-1684"><a href="https://www.proveris.com/vereo-automated-actuators-for-nasal-and-oral-devices/" class="jet-custom-nav__item-link"><span class="jet-menu-link-text"><span class="jet-custom-item-label top-level-label">Vereo<sup>®</sup> Actuators for Nasal Devices</span></span></a></div><div class="menu-item menu-item-type-post_type menu-item-object-page jet-custom-nav__item jet-custom-nav__item-1686"><a href="https://www.proveris.com/viota-software/" class="jet-custom-nav__item-link"><span class="jet-menu-link-text"><span class="jet-custom-item-label top-level-label">Viota<sup>®</sup> Software</span></span></a></div><div class="menu-item menu-item-type-post_type menu-item-object-page jet-custom-nav__item jet-custom-nav__item-4698"><a href="https://www.proveris.com/vereo-spray-weigh-collect-for-nasal-dose-content-uniformity-testing/" class="jet-custom-nav__item-link"><span class="jet-menu-link-text"><span class="jet-custom-item-label top-level-label">Vereo® Spray Weigh Collect System</span></span></a></div><div class="menu-item menu-item-type-post_type menu-item-object-page jet-custom-nav__item jet-custom-nav__item-1682"><a href="https://www.proveris.com/indizo/" class="jet-custom-nav__item-link"><span class="jet-menu-link-text"><span class="jet-custom-item-label top-level-label">Indizo<sup>®</sup> Automated Collection System</span></span></a></div></div></div></div></div></div></div><div class="elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-ca90e8c" data-id="ca90e8c" data-element_type="column"><div class="elementor-widget-wrap elementor-element-populated"><div class="elementor-element elementor-element-48e0d15 elementor-widget elementor-widget-spacer" data-id="48e0d15" data-element_type="widget" data-widget_type="spacer.default"><div class="elementor-widget-container"><div class="elementor-spacer"><div class="elementor-spacer-inner"></div></div></div></div><div class="elementor-element elementor-element-2de5455 elementor-widget elementor-widget-heading" data-id="2de5455" data-element_type="widget" data-widget_type="heading.default"><div class="elementor-widget-container"><h2 class="elementor-heading-title elementor-size-default">ORAL PRODUCTS</h2></div></div><div class="elementor-element elementor-element-c6ba134 elementor-widget elementor-widget-jet-custom-menu" data-id="c6ba134" data-element_type="widget" data-widget_type="jet-custom-menu.default"><div class="elementor-widget-container"><div class="menu-oral-products-container"><div class="jet-custom-nav jet-custom-nav--dropdown-right-side jet-custom-nav--animation-fade"><div class="menu-item menu-item-type-post_type menu-item-object-page jet-custom-nav__item jet-custom-nav__item-1687"><a href="https://www.proveris.com/sprayview-measurement-systems/" class="jet-custom-nav__item-link"><span class="jet-menu-link-text"><span class="jet-custom-item-label top-level-label">SprayVIEW<sup>®</sup> Measurement Systems</span></span></a></div><div class="menu-item menu-item-type-post_type menu-item-object-page jet-custom-nav__item jet-custom-nav__item-1689"><a href="https://www.proveris.com/vereo-automated-actuators-for-pmdi-devices/" class="jet-custom-nav__item-link"><span class="jet-menu-link-text"><span class="jet-custom-item-label top-level-label">Vereo<sup>®</sup> Actuators for PMDI Devices</span></span></a></div><div class="menu-item menu-item-type-post_type menu-item-object-page jet-custom-nav__item jet-custom-nav__item-1690"><a href="https://www.proveris.com/viota-software/" class="jet-custom-nav__item-link"><span class="jet-menu-link-text"><span class="jet-custom-item-label top-level-label">Viota<sup>®</sup> Software</span></span></a></div><div class="menu-item menu-item-type-post_type menu-item-object-page jet-custom-nav__item jet-custom-nav__item-4094"><a href="https://www.proveris.com/kinaero-cx-pmdi-collection-system/" class="jet-custom-nav__item-link"><span class="jet-menu-link-text"><span class="jet-custom-item-label top-level-label">Kinaero Cx<span><sup>TM</sup></span> PMDI Collection System</span></span></a></div><div class="menu-item menu-item-type-post_type menu-item-object-page jet-custom-nav__item jet-custom-nav__item-1691"><a href="https://www.proveris.com/kinaero-pmdi-fire-down-systems/" class="jet-custom-nav__item-link"><span class="jet-menu-link-text"><span class="jet-custom-item-label top-level-label">Kinaero<sup>®</sup> Fire Down Systems</span></span></a></div></div></div></div></div></div></div><div class="elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-7fe0f8f" data-id="7fe0f8f" data-element_type="column"><div class="elementor-widget-wrap elementor-element-populated"><div class="elementor-element elementor-element-1acc214 elementor-widget elementor-widget-spacer" data-id="1acc214" data-element_type="widget" data-widget_type="spacer.default"><div class="elementor-widget-container"><div class="elementor-spacer"><div class="elementor-spacer-inner"></div></div></div></div><div class="elementor-element elementor-element-a753cb8 elementor-widget elementor-widget-heading" data-id="a753cb8" data-element_type="widget" data-widget_type="heading.default"><div class="elementor-widget-container"><h2 class="elementor-heading-title elementor-size-default">ACCESSORIES</h2></div></div><div class="elementor-element elementor-element-522769d elementor-widget elementor-widget-jet-custom-menu" data-id="522769d" data-element_type="widget" data-widget_type="jet-custom-menu.default"><div class="elementor-widget-container"><div class="menu-accessories-container"><div class="jet-custom-nav jet-custom-nav--dropdown-right-side jet-custom-nav--animation-fade"><div class="menu-item menu-item-type-post_type menu-item-object-page jet-custom-nav__item jet-custom-nav__item-4817"><a href="https://www.proveris.com/dusa-dosage-unit-sampling-apparatus/" class="jet-custom-nav__item-link"><span class="jet-menu-link-text"><span class="jet-custom-item-label top-level-label">Dosage Unit Sampling Apparatus (DUSA)</span></span></a></div><div class="menu-item menu-item-type-post_type menu-item-object-page jet-custom-nav__item jet-custom-nav__item-1694"><a href="https://www.proveris.com/device-holders-and-cassettes/" class="jet-custom-nav__item-link"><span class="jet-menu-link-text"><span class="jet-custom-item-label top-level-label">Device Holders & Cassettes</span></span></a></div><div class="menu-item menu-item-type-post_type menu-item-object-page jet-custom-nav__item jet-custom-nav__item-1695"><a href="https://www.proveris.com/spray-content-uniformity-and-waste-collection-kits-for-vereo-actuator-nsx/" class="jet-custom-nav__item-link"><span class="jet-menu-link-text"><span class="jet-custom-item-label top-level-label">Sample Collection & Wasting Kits</span></span></a></div><div class="menu-item menu-item-type-post_type menu-item-object-page jet-custom-nav__item jet-custom-nav__item-1696"><a href="https://www.proveris.com/actuator-stands-and-other-items/" class="jet-custom-nav__item-link"><span class="jet-menu-link-text"><span class="jet-custom-item-label top-level-label">Actuator Stands & Other Items</span></span></a></div></div></div></div></div></div></div></div></section></div></div></div></li><li id="jet-mega-menu-item-1751" class="jet-mega-menu-item jet-mega-menu-item-type-custom jet-mega-menu-item-object-custom jet-mega-menu-item-has-children jet-mega-menu-item--default jet-mega-menu-item--top-level jet-mega-menu-item-1751"><div class="jet-mega-menu-item__inner" tabindex="0" aria-label="Support"><a class="jet-mega-menu-item__link jet-mega-menu-item__link--top-level"><div class="jet-mega-menu-item__title"><div class="jet-mega-menu-item__label">Support</div></div></a><div class="jet-mega-menu-item__dropdown"><i class="fas fa-angle-down"></i></div></div><div class='jet-mega-menu-sub-menu'><ul class="jet-mega-menu-sub-menu__list"><li id="jet-mega-menu-item-1851" class="jet-mega-menu-item jet-mega-menu-item-type-post_type jet-mega-menu-item-object-page jet-mega-menu-item--default jet-mega-menu-item--sub-level jet-mega-menu-item-1851"><div class="jet-mega-menu-item__inner" tabindex="0" aria-label="Instrument and Application Support"><a href="https://www.proveris.com/instrument-and-application-support/" class="jet-mega-menu-item__link jet-mega-menu-item__link--sub-level"><div class="jet-mega-menu-item__title"><div class="jet-mega-menu-item__label">Instrument and Application Support</div></div></a></div></li><li id="jet-mega-menu-item-1753" class="jet-mega-menu-item jet-mega-menu-item-type-post_type jet-mega-menu-item-object-page jet-mega-menu-item--default jet-mega-menu-item--sub-level jet-mega-menu-item-1753"><div class="jet-mega-menu-item__inner" tabindex="0" aria-label="Service Contracts"><a href="https://www.proveris.com/service-contracts/" class="jet-mega-menu-item__link jet-mega-menu-item__link--sub-level"><div class="jet-mega-menu-item__title"><div class="jet-mega-menu-item__label">Service Contracts</div></div></a></div></li><li id="jet-mega-menu-item-1842" class="jet-mega-menu-item jet-mega-menu-item-type-post_type jet-mega-menu-item-object-page jet-mega-menu-item--default jet-mega-menu-item--sub-level jet-mega-menu-item-1842"><div class="jet-mega-menu-item__inner" tabindex="0" aria-label="Training Programs"><a href="https://www.proveris.com/training-programs/" class="jet-mega-menu-item__link jet-mega-menu-item__link--sub-level"><div class="jet-mega-menu-item__title"><div class="jet-mega-menu-item__label">Training Programs</div></div></a></div></li><li id="jet-mega-menu-item-1855" class="jet-mega-menu-item jet-mega-menu-item-type-post_type jet-mega-menu-item-object-page jet-mega-menu-item--default jet-mega-menu-item--sub-level jet-mega-menu-item-1855"><div class="jet-mega-menu-item__inner" tabindex="0" aria-label="Validation Services"><a href="https://www.proveris.com/validation-services/" class="jet-mega-menu-item__link jet-mega-menu-item__link--sub-level"><div class="jet-mega-menu-item__title"><div class="jet-mega-menu-item__label">Validation Services</div></div></a></div></li></ul></div></li><li id="jet-mega-menu-item-794" 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elementor-col-100 elementor-top-column elementor-element elementor-element-4a39b8db raven-column-flex-space-between raven-column-flex-horizontal" data-id="4a39b8db" data-element_type="column"><div class="elementor-widget-wrap elementor-element-populated"><div class="elementor-element elementor-element-35f1e291 elementor-widget elementor-widget-raven-site-logo" data-id="35f1e291" data-element_type="widget" data-widget_type="raven-site-logo.default"><div class="elementor-widget-container"><div class="raven-widget-wrapper"><div class="raven-site-logo raven-site-logo-customizer"> <a class="raven-site-logo-link" href="https://www.proveris.com"> <picture><img srcset="https://www.proveris.com/wp-content/uploads/2019/04/proveris_h_rgb.png 1x, https://www.proveris.com/wp-content/uploads/2019/04/proveris_h_rgb.png 2x" src="https://www.proveris.com/wp-content/uploads/2019/04/proveris_h_rgb.png" alt="Proveris Scientific" data-no-lazy="1" /></picture> </a></div></div></div></div><div class="elementor-element elementor-element-1207114a elementor-widget elementor-widget-raven-flex-spacer" data-id="1207114a" data-element_type="widget" data-widget_type="raven-flex-spacer.default"><div class="elementor-widget-container"><div class="raven-spacer"> </div></div></div><div class="elementor-element elementor-element-5705d9c elementor-widget elementor-widget-jet-mega-menu" data-id="5705d9c" data-element_type="widget" data-widget_type="jet-mega-menu.default"><div class="elementor-widget-container"><div class="jet-mega-menu jet-mega-menu--layout-horizontal jet-mega-menu--sub-position-right jet-mega-menu--dropdown-layout-default jet-mega-menu--dropdown-position-right jet-mega-menu--animation-none jet-mega-menu--location-elementor jet-mega-menu--fill-svg-icons" 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jet-mega-menu-item--sub-level jet-mega-menu-item-1147"><div class="jet-mega-menu-item__inner" tabindex="0" aria-label="Company Overview"><a href="https://www.proveris.com/about-us/#companyoverview" class="jet-mega-menu-item__link jet-mega-menu-item__link--sub-level"><div class="jet-mega-menu-item__title"><div class="jet-mega-menu-item__label">Company Overview</div></div></a></div></li><li class="jet-mega-menu-item jet-mega-menu-item-type-custom jet-mega-menu-item-object-custom jet-mega-menu-item--default jet-mega-menu-item--sub-level jet-mega-menu-item-1150"><div class="jet-mega-menu-item__inner" tabindex="0" aria-label="Corporate Values"><a href="https://www.proveris.com/about-us/#corporatevalues" class="jet-mega-menu-item__link jet-mega-menu-item__link--sub-level"><div class="jet-mega-menu-item__title"><div class="jet-mega-menu-item__label">Corporate Values</div></div></a></div></li><li class="jet-mega-menu-item jet-mega-menu-item-type-custom jet-mega-menu-item-object-custom 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.elementor-element.elementor-element-ca90e8c{width:36.653%;}}</style><div data-elementor-type="wp-post" data-elementor-id="1413" class="elementor elementor-1413"><section class="elementor-section elementor-top-section elementor-element elementor-element-6be66f2 elementor-section-full_width elementor-section-content-top elementor-section-height-default elementor-section-height-default" data-id="6be66f2" data-element_type="section" data-settings="{"jet_parallax_layout_list":[{"jet_parallax_layout_image":{"url":"","id":"","size":""},"_id":"d72bfaa","jet_parallax_layout_image_tablet":{"url":"","id":"","size":""},"jet_parallax_layout_image_mobile":{"url":"","id":"","size":""},"jet_parallax_layout_speed":{"unit":"%","size":50,"sizes":[]},"jet_parallax_layout_type":"scroll","jet_parallax_layout_z_index":"","jet_parallax_layout_bg_x":50,"jet_parallax_layout_bg_y":50,"jet_parallax_layout_bg_size":"auto","jet_parallax_layout_animation_prop":"transform","jet_parallax_layout_on":["desktop","tablet"],"jet_parallax_layout_direction":null,"jet_parallax_layout_fx_direction":null,"jet_parallax_layout_bg_x_tablet":"","jet_parallax_layout_bg_x_mobile":"","jet_parallax_layout_bg_y_tablet":"","jet_parallax_layout_bg_y_mobile":"","jet_parallax_layout_bg_size_tablet":"","jet_parallax_layout_bg_size_mobile":""}]}"><div class="elementor-container elementor-column-gap-default"><div class="elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-d394276" data-id="d394276" data-element_type="column"><div class="elementor-widget-wrap elementor-element-populated"><div class="elementor-element elementor-element-003521d elementor-widget elementor-widget-spacer" data-id="003521d" data-element_type="widget" data-widget_type="spacer.default"><div class="elementor-widget-container"><div class="elementor-spacer"><div class="elementor-spacer-inner"></div></div></div></div><div class="elementor-element elementor-element-6347580e elementor-widget elementor-widget-heading" data-id="6347580e" data-element_type="widget" data-widget_type="heading.default"><div class="elementor-widget-container"><h2 class="elementor-heading-title elementor-size-default">NASAL PRODUCTS</h2></div></div><div class="elementor-element elementor-element-b6f9f87 elementor-widget elementor-widget-jet-custom-menu" data-id="b6f9f87" data-element_type="widget" data-widget_type="jet-custom-menu.default"><div class="elementor-widget-container"><div class="menu-nasal-products-container"><div class="jet-custom-nav jet-custom-nav--dropdown-right-side jet-custom-nav--animation-fade"><div class="menu-item menu-item-type-post_type menu-item-object-page jet-custom-nav__item jet-custom-nav__item-1683"><a href="https://www.proveris.com/sprayview-measurement-systems/" class="jet-custom-nav__item-link"><span class="jet-menu-link-text"><span class="jet-custom-item-label top-level-label">SprayVIEW<sup>®</sup> Measurement Systems</span></span></a></div><div class="menu-item menu-item-type-post_type menu-item-object-page jet-custom-nav__item jet-custom-nav__item-1684"><a href="https://www.proveris.com/vereo-automated-actuators-for-nasal-and-oral-devices/" class="jet-custom-nav__item-link"><span class="jet-menu-link-text"><span class="jet-custom-item-label top-level-label">Vereo<sup>®</sup> Actuators for Nasal Devices</span></span></a></div><div class="menu-item menu-item-type-post_type menu-item-object-page jet-custom-nav__item jet-custom-nav__item-1686"><a href="https://www.proveris.com/viota-software/" class="jet-custom-nav__item-link"><span class="jet-menu-link-text"><span class="jet-custom-item-label top-level-label">Viota<sup>®</sup> Software</span></span></a></div><div class="menu-item menu-item-type-post_type menu-item-object-page jet-custom-nav__item jet-custom-nav__item-4698"><a href="https://www.proveris.com/vereo-spray-weigh-collect-for-nasal-dose-content-uniformity-testing/" class="jet-custom-nav__item-link"><span class="jet-menu-link-text"><span class="jet-custom-item-label top-level-label">Vereo® Spray Weigh Collect System</span></span></a></div><div class="menu-item menu-item-type-post_type menu-item-object-page jet-custom-nav__item jet-custom-nav__item-1682"><a href="https://www.proveris.com/indizo/" class="jet-custom-nav__item-link"><span class="jet-menu-link-text"><span class="jet-custom-item-label top-level-label">Indizo<sup>®</sup> Automated Collection System</span></span></a></div></div></div></div></div></div></div><div class="elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-ca90e8c" data-id="ca90e8c" data-element_type="column"><div class="elementor-widget-wrap elementor-element-populated"><div class="elementor-element elementor-element-48e0d15 elementor-widget elementor-widget-spacer" data-id="48e0d15" data-element_type="widget" data-widget_type="spacer.default"><div class="elementor-widget-container"><div class="elementor-spacer"><div class="elementor-spacer-inner"></div></div></div></div><div class="elementor-element elementor-element-2de5455 elementor-widget elementor-widget-heading" data-id="2de5455" data-element_type="widget" data-widget_type="heading.default"><div class="elementor-widget-container"><h2 class="elementor-heading-title elementor-size-default">ORAL PRODUCTS</h2></div></div><div class="elementor-element elementor-element-c6ba134 elementor-widget elementor-widget-jet-custom-menu" data-id="c6ba134" data-element_type="widget" data-widget_type="jet-custom-menu.default"><div class="elementor-widget-container"><div class="menu-oral-products-container"><div class="jet-custom-nav jet-custom-nav--dropdown-right-side jet-custom-nav--animation-fade"><div class="menu-item menu-item-type-post_type menu-item-object-page jet-custom-nav__item jet-custom-nav__item-1687"><a href="https://www.proveris.com/sprayview-measurement-systems/" class="jet-custom-nav__item-link"><span class="jet-menu-link-text"><span class="jet-custom-item-label top-level-label">SprayVIEW<sup>®</sup> Measurement Systems</span></span></a></div><div class="menu-item menu-item-type-post_type menu-item-object-page jet-custom-nav__item jet-custom-nav__item-1689"><a href="https://www.proveris.com/vereo-automated-actuators-for-pmdi-devices/" class="jet-custom-nav__item-link"><span class="jet-menu-link-text"><span class="jet-custom-item-label top-level-label">Vereo<sup>®</sup> Actuators for PMDI Devices</span></span></a></div><div class="menu-item menu-item-type-post_type menu-item-object-page jet-custom-nav__item jet-custom-nav__item-1690"><a href="https://www.proveris.com/viota-software/" class="jet-custom-nav__item-link"><span class="jet-menu-link-text"><span class="jet-custom-item-label top-level-label">Viota<sup>®</sup> Software</span></span></a></div><div class="menu-item menu-item-type-post_type menu-item-object-page jet-custom-nav__item jet-custom-nav__item-4094"><a href="https://www.proveris.com/kinaero-cx-pmdi-collection-system/" class="jet-custom-nav__item-link"><span class="jet-menu-link-text"><span class="jet-custom-item-label top-level-label">Kinaero Cx<span><sup>TM</sup></span> PMDI Collection System</span></span></a></div><div class="menu-item menu-item-type-post_type menu-item-object-page jet-custom-nav__item jet-custom-nav__item-1691"><a href="https://www.proveris.com/kinaero-pmdi-fire-down-systems/" class="jet-custom-nav__item-link"><span class="jet-menu-link-text"><span class="jet-custom-item-label top-level-label">Kinaero<sup>®</sup> Fire Down Systems</span></span></a></div></div></div></div></div></div></div><div class="elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-7fe0f8f" data-id="7fe0f8f" data-element_type="column"><div class="elementor-widget-wrap elementor-element-populated"><div class="elementor-element elementor-element-1acc214 elementor-widget elementor-widget-spacer" data-id="1acc214" data-element_type="widget" data-widget_type="spacer.default"><div class="elementor-widget-container"><div class="elementor-spacer"><div class="elementor-spacer-inner"></div></div></div></div><div class="elementor-element elementor-element-a753cb8 elementor-widget elementor-widget-heading" data-id="a753cb8" data-element_type="widget" data-widget_type="heading.default"><div class="elementor-widget-container"><h2 class="elementor-heading-title elementor-size-default">ACCESSORIES</h2></div></div><div class="elementor-element elementor-element-522769d elementor-widget elementor-widget-jet-custom-menu" data-id="522769d" data-element_type="widget" data-widget_type="jet-custom-menu.default"><div class="elementor-widget-container"><div class="menu-accessories-container"><div class="jet-custom-nav jet-custom-nav--dropdown-right-side jet-custom-nav--animation-fade"><div class="menu-item menu-item-type-post_type menu-item-object-page jet-custom-nav__item jet-custom-nav__item-4817"><a href="https://www.proveris.com/dusa-dosage-unit-sampling-apparatus/" class="jet-custom-nav__item-link"><span class="jet-menu-link-text"><span class="jet-custom-item-label top-level-label">Dosage Unit Sampling Apparatus (DUSA)</span></span></a></div><div class="menu-item menu-item-type-post_type menu-item-object-page jet-custom-nav__item jet-custom-nav__item-1694"><a href="https://www.proveris.com/device-holders-and-cassettes/" class="jet-custom-nav__item-link"><span class="jet-menu-link-text"><span class="jet-custom-item-label top-level-label">Device Holders & Cassettes</span></span></a></div><div class="menu-item menu-item-type-post_type menu-item-object-page jet-custom-nav__item jet-custom-nav__item-1695"><a href="https://www.proveris.com/spray-content-uniformity-and-waste-collection-kits-for-vereo-actuator-nsx/" class="jet-custom-nav__item-link"><span class="jet-menu-link-text"><span class="jet-custom-item-label top-level-label">Sample Collection & Wasting Kits</span></span></a></div><div class="menu-item menu-item-type-post_type menu-item-object-page jet-custom-nav__item jet-custom-nav__item-1696"><a href="https://www.proveris.com/actuator-stands-and-other-items/" class="jet-custom-nav__item-link"><span class="jet-menu-link-text"><span class="jet-custom-item-label top-level-label">Actuator Stands & Other Items</span></span></a></div></div></div></div></div></div></div></div></section></div></div></div></li><li class="jet-mega-menu-item jet-mega-menu-item-type-custom jet-mega-menu-item-object-custom jet-mega-menu-item-has-children jet-mega-menu-item--default jet-mega-menu-item--top-level jet-mega-menu-item-1751"><div class="jet-mega-menu-item__inner" tabindex="0" aria-label="Support"><a class="jet-mega-menu-item__link jet-mega-menu-item__link--top-level"><div class="jet-mega-menu-item__title"><div class="jet-mega-menu-item__label">Support</div></div></a><div class="jet-mega-menu-item__dropdown"><i class="fas fa-angle-down"></i></div></div><div class='jet-mega-menu-sub-menu'><ul class="jet-mega-menu-sub-menu__list"><li class="jet-mega-menu-item jet-mega-menu-item-type-post_type jet-mega-menu-item-object-page jet-mega-menu-item--default jet-mega-menu-item--sub-level jet-mega-menu-item-1851"><div class="jet-mega-menu-item__inner" tabindex="0" aria-label="Instrument and Application 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data-element_type="section" data-settings="{"jet_parallax_layout_list":[{"jet_parallax_layout_image":{"url":"","id":"","size":""},"_id":"5e2f82b","jet_parallax_layout_speed":{"unit":"%","size":50,"sizes":[]},"jet_parallax_layout_image_tablet":{"url":"","id":"","size":""},"jet_parallax_layout_image_mobile":{"url":"","id":"","size":""},"jet_parallax_layout_type":"scroll","jet_parallax_layout_direction":null,"jet_parallax_layout_fx_direction":null,"jet_parallax_layout_z_index":"","jet_parallax_layout_bg_x":50,"jet_parallax_layout_bg_x_tablet":"","jet_parallax_layout_bg_x_mobile":"","jet_parallax_layout_bg_y":50,"jet_parallax_layout_bg_y_tablet":"","jet_parallax_layout_bg_y_mobile":"","jet_parallax_layout_bg_size":"auto","jet_parallax_layout_bg_size_tablet":"","jet_parallax_layout_bg_size_mobile":"","jet_parallax_layout_animation_prop":"transform","jet_parallax_layout_on":["desktop","tablet"]}],"background_background":"classic"}"><div class="elementor-background-overlay"></div><div class="elementor-container elementor-column-gap-default"><div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-43642d4" data-id="43642d4" data-element_type="column"><div class="elementor-widget-wrap elementor-element-populated"><div class="elementor-element elementor-element-bdc9688 elementor-widget elementor-widget-heading" data-id="bdc9688" data-element_type="widget" data-widget_type="heading.default"><div class="elementor-widget-container"><h2 class="elementor-heading-title elementor-size-default">WorldWIDE</h2></div></div><div class="elementor-element elementor-element-4208c88 elementor-widget elementor-widget-heading" data-id="4208c88" data-element_type="widget" data-widget_type="heading.default"><div class="elementor-widget-container"><h2 class="elementor-heading-title elementor-size-default">REGULATORY GUIDANCE</h2></div></div></div></div></div></section><section class="elementor-section elementor-top-section elementor-element elementor-element-5598d31 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="5598d31" data-element_type="section" data-settings="{"jet_parallax_layout_list":[{"jet_parallax_layout_image":{"url":"","id":"","size":""},"_id":"199666b","jet_parallax_layout_image_tablet":{"url":"","id":"","size":""},"jet_parallax_layout_image_mobile":{"url":"","id":"","size":""},"jet_parallax_layout_speed":{"unit":"%","size":50,"sizes":[]},"jet_parallax_layout_type":"scroll","jet_parallax_layout_direction":null,"jet_parallax_layout_fx_direction":null,"jet_parallax_layout_z_index":"","jet_parallax_layout_bg_x":50,"jet_parallax_layout_bg_x_tablet":"","jet_parallax_layout_bg_x_mobile":"","jet_parallax_layout_bg_y":50,"jet_parallax_layout_bg_y_tablet":"","jet_parallax_layout_bg_y_mobile":"","jet_parallax_layout_bg_size":"auto","jet_parallax_layout_bg_size_tablet":"","jet_parallax_layout_bg_size_mobile":"","jet_parallax_layout_animation_prop":"transform","jet_parallax_layout_on":["desktop","tablet"]}]}"><div class="elementor-container elementor-column-gap-default"><div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-5e573d7" data-id="5e573d7" data-element_type="column"><div class="elementor-widget-wrap elementor-element-populated"><div class="elementor-element elementor-element-5405578 elementor-widget elementor-widget-spacer" data-id="5405578" data-element_type="widget" data-widget_type="spacer.default"><div class="elementor-widget-container"><div class="elementor-spacer"><div class="elementor-spacer-inner"></div></div></div></div></div></div></div></section><section class="elementor-section elementor-top-section elementor-element elementor-element-176f5328 elementor-section-content-middle elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="176f5328" data-element_type="section" data-settings="{"jet_parallax_layout_list":[{"jet_parallax_layout_image":{"url":"","id":"","size":""},"_id":"d2ef4c5","jet_parallax_layout_image_tablet":{"url":"","id":"","size":""},"jet_parallax_layout_image_mobile":{"url":"","id":"","size":""},"jet_parallax_layout_speed":{"unit":"%","size":50,"sizes":[]},"jet_parallax_layout_type":"scroll","jet_parallax_layout_direction":null,"jet_parallax_layout_fx_direction":null,"jet_parallax_layout_z_index":"","jet_parallax_layout_bg_x":50,"jet_parallax_layout_bg_x_tablet":"","jet_parallax_layout_bg_x_mobile":"","jet_parallax_layout_bg_y":50,"jet_parallax_layout_bg_y_tablet":"","jet_parallax_layout_bg_y_mobile":"","jet_parallax_layout_bg_size":"auto","jet_parallax_layout_bg_size_tablet":"","jet_parallax_layout_bg_size_mobile":"","jet_parallax_layout_animation_prop":"transform","jet_parallax_layout_on":["desktop","tablet"]}]}"><div class="elementor-container elementor-column-gap-default"><div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-387be1e6" data-id="387be1e6" data-element_type="column"><div class="elementor-widget-wrap elementor-element-populated"><div class="elementor-element elementor-element-2054fd3 elementor-widget elementor-widget-heading" data-id="2054fd3" data-element_type="widget" data-widget_type="heading.default"><div class="elementor-widget-container"><h2 class="elementor-heading-title elementor-size-default">At present, there are no worldwide standards that are specifically applicable to Orally Inhaled and Nasal Drug Products (OINDPs). Below are regulatory agencies by region, a harmonizing organization, and selected recommended guidelines for safety, quality and efficacy.</h2></div></div><div class="elementor-element elementor-element-b3d0f26 elementor-widget elementor-widget-spacer" data-id="b3d0f26" data-element_type="widget" data-widget_type="spacer.default"><div class="elementor-widget-container"><div class="elementor-spacer"><div class="elementor-spacer-inner"></div></div></div></div><div class="elementor-element elementor-element-a5945da elementor-widget elementor-widget-jet-accordion" data-id="a5945da" data-element_type="widget" data-widget_type="jet-accordion.default"><div class="elementor-widget-container"><div class="jet-accordion" data-settings="{"collapsible":false,"ajaxTemplate":false,"switchScrolling":false,"switchScrollingOffset":0,"switchScrollingDelay":500}"><div class="jet-accordion__inner"><div class="jet-accordion__item jet-toggle jet-toggle-move-up-effect "><div id="jet-toggle-control-1731" class="jet-toggle__control elementor-menu-anchor" data-toggle="1" role="button" tabindex="0" aria-controls="jet-toggle-content-1731" aria-expanded="false" data-template-id="false"><div class="jet-toggle__label-icon jet-toggle-icon-position-left"><span class="jet-toggle__icon icon-normal jet-tabs-icon"><i class="fas fa-plus"></i></span><span class="jet-toggle__icon icon-active jet-tabs-icon"><i class="fas fa-minus"></i></span></div><div class="jet-toggle__label-text">International Conference on Harmonisation of Technical Requirements</div></div><div id="jet-toggle-content-1731" class="jet-toggle__content" data-toggle="1" role="region" data-template-id="false"><div class="jet-toggle__content-inner"><p><img src="https://www.proveris.com/wp-content/plugins/lazy-load/images/1x1.trans.gif" data-lazy-src="https://www.proveris.com//wp-content/uploads/2019/09/2978890-300x117.jpg" decoding="async" class="alignnone size-medium wp-image-1821" alt width="300" height="117" srcset="https://www.proveris.com/wp-content/uploads/2019/09/2978890-300x117.jpg 300w, https://www.proveris.com/wp-content/uploads/2019/09/2978890-768x300.jpg 768w, https://www.proveris.com/wp-content/uploads/2019/09/2978890.jpg 805w" sizes="(max-width: 300px) 100vw, 300px"><noscript><img decoding="async" class="alignnone size-medium wp-image-1821" src="https://www.proveris.com//wp-content/uploads/2019/09/2978890-300x117.jpg" alt="" width="300" height="117" srcset="https://www.proveris.com/wp-content/uploads/2019/09/2978890-300x117.jpg 300w, https://www.proveris.com/wp-content/uploads/2019/09/2978890-768x300.jpg 768w, https://www.proveris.com/wp-content/uploads/2019/09/2978890.jpg 805w" sizes="(max-width: 300px) 100vw, 300px" /></noscript></p><p>The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique organisation consisting of representatives from the regulatory authorities in the European Union (EMA), Japan (MHLW) and the USA (FDA), and experts from the pharmaceutical industry in the three regions, in a single forum. ICH has concentrated on the preparation of the following quality related guidelines:</p><ul class="elementor-icon-list-items"><li class="elementor-icon-list-item"><a href="https://www.ich.org/products/guidelines/quality/article/quality-guidelines.html" target="_blank" rel="noopener"><span class="elementor-icon-list-text">ICH Q8 (R2) Pharmaceutical Development</span></a></li><li class="elementor-icon-list-item"><a href="https://www.ich.org/products/guidelines/quality/article/quality-guidelines.html" target="_blank" rel="noopener"><span class="elementor-icon-list-text">ICH Q9 Quality Risk Management</span></a></li><li class="elementor-icon-list-item"><a href="https://www.ich.org/products/guidelines/quality/article/quality-guidelines.html" target="_blank" rel="noopener"><span class="elementor-icon-list-text">ICH Q10 Pharmaceutical Quality System</span></a></li><li><a href="https://www.ich.org/products/guidelines/quality/article/quality-guidelines.html" target="_blank" rel="noopener"><span class="elementor-icon-list-text">ICH Q11 Development and Manufacture of Drug Substances</span></a></li><li><p class="p1"><a href="https://database.ich.org/sites/default/files/Q12_Guideline_Step4_2019_1119.pdf">ICH Q12 Pharmaceutical Product Lifecycle Management<br /></a></p></li></ul></div></div></div><div class="jet-accordion__item jet-toggle jet-toggle-move-up-effect "><div id="jet-toggle-control-1732" class="jet-toggle__control elementor-menu-anchor" data-toggle="2" role="button" tabindex="0" aria-controls="jet-toggle-content-1732" aria-expanded="false" data-template-id="false"><div class="jet-toggle__label-icon jet-toggle-icon-position-left"><span class="jet-toggle__icon icon-normal jet-tabs-icon"><i class="fas fa-plus"></i></span><span class="jet-toggle__icon icon-active jet-tabs-icon"><i class="fas fa-minus"></i></span></div><div class="jet-toggle__label-text">Food and Drug Administration (FDA)</div></div><div id="jet-toggle-content-1732" class="jet-toggle__content" data-toggle="2" role="region" data-template-id="false"><div class="jet-toggle__content-inner"><p><img src="https://www.proveris.com/wp-content/plugins/lazy-load/images/1x1.trans.gif" data-lazy-src="https://www.proveris.com//wp-content/uploads/2019/10/FDA-Logo-623p-x-423p-300x69.jpg" decoding="async" class="alignnone wp-image-2652 size-medium" alt width="300" height="69" srcset="https://www.proveris.com/wp-content/uploads/2019/10/FDA-Logo-623p-x-423p-300x69.jpg 300w, https://www.proveris.com/wp-content/uploads/2019/10/FDA-Logo-623p-x-423p.jpg 400w" sizes="(max-width: 300px) 100vw, 300px"><noscript><img decoding="async" class="alignnone wp-image-2652 size-medium" src="https://www.proveris.com//wp-content/uploads/2019/10/FDA-Logo-623p-x-423p-300x69.jpg" alt="" width="300" height="69" srcset="https://www.proveris.com/wp-content/uploads/2019/10/FDA-Logo-623p-x-423p-300x69.jpg 300w, https://www.proveris.com/wp-content/uploads/2019/10/FDA-Logo-623p-x-423p.jpg 400w" sizes="(max-width: 300px) 100vw, 300px" /></noscript></p><p>In the USA, the regulatory function is performed by the Food and Drug Administration (FDA) through two centers, the Center for Drug Evaluation and Research (CDER) in respect of medicines and the Center for Devices and Radiologic Health (CDRH) in respect of medical devices.</p><p>The FDA’s relevant current thinking for orally inhaled and nasal drug products is reflected in the following <a href="https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry" target="_blank" rel="noopener">Regulatory Guidances for Industry</a>:</p><p><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/metered-dose-inhaler-mdi-and-dry-powder-inhaler-dpi-drug-products-quality-considerations" target="_blank" rel="noopener">(CDER 2018), Metered Dose Inhaler (MDI) & Dry Powder Inhaler (DPI) Products – Quality Considerations Guidance for Industry”, Pharmaceutical Quality/CMC Documentation – Draft</a></p><p><a href="https://www.fda.gov/media/75081/download" target="_blank" rel="noopener">(CDER 2017), Bioequivalence Summary Table for Metered Dose Inhaler Products, Technical Specifications Documentation</a></p><p><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/bioavailability-and-bioequivalence-studies-nasal-aerosols-and-nasal-sprays-local-action" target="_blank" rel="noopener">(CDER 2003), Bioavailability and bioequivalence studies for nasal sprays for local action, Biopharmaceutics – Draft</a></p><p><a href="https://www.fda.gov/media/78375/download" target="_blank" rel="noopener">(CDER 2003) Bioequivalence summary tables related to the in vitro tests recommended in “Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action</a></p><p><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/nasal-spray-and-inhalation-solution-suspension-and-drug-products" target="_blank" rel="noopener">(CDER 2002), Nasal Spray and Inhalation Solution, Suspension and Spray Drug Products, Chemistry, Manufacturing and Controls</a></p><p><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/integration-dose-counting-mechanisms-mdi-drug-products" target="_blank" rel="noopener">(CDER 2003), Integration of Dose-Counting Mechanisms into MDI Drug Products, Clinical Medical</a></p><p><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/sterility-requirement-aqueous-based-drug-products-oral-inhalation-small-entity-compliance-guide" target="_blank" rel="noopener">(CDER 2001), Sterility Requirements for Aqueous-Based Drug Products for Oral Inhalation, Small Entity Compliance Guides</a></p><p><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/anda-submissions-amendments-abbreviated-new-drug-applications-under-gdufa" target="_blank" rel="noopener">(CDER 2018), ANDA Submissions — Amendments to Abbreviated New Drug Applications Under, Generics</a></p><p><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/process-validation-general-principles-and-practices" target="_blank" rel="noopener">(CDER 2011), Process Validation: General Principles and Practices Guidance for Industry, Good Manufacturing Practices</a></p><p><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-490100-process-validation-requirements-drug-products-and-active-pharmaceutical-ingredients" target="_blank" rel="noopener">(CDER 2004), Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market Approval</a></p><p><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reviewer-guidance-nebulizers-metered-dose-inhalers-spacers-and-actuators">(CDER 1993) Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators</a></p><p><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/current-good-manufacturing-practice-requirements-combination-products">(CDER 2017) Current Good Manufacturing Practice Requirements for Combination Products</a></p><p><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/comparative-analyses-and-related-comparative-use-human-factors-studies-drug-device-combination">(CDER 2017) Draft Guidance for Industry – Comparative Analyses and Related Comparative Use Human Factors Studies for A Drug-device Combination Product Submitted in an ANDA</a></p><p><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/human-factors-studies-and-related-clinical-study-considerations-combination-product-design-and">(CDER 2016) Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development: Draft Guidance for Industry and FDA Staff</a></p><p><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/list-highest-priority-devices-human-factors-review">(CDER 2016) List of Highest Priority Devices for Human Factors Review: Draft Guidance for Industry and Food and Drug Administration Staff</a></p><p><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/allergic-rhinitis-developing-drug-products-treatment-guidance-industry">(CDER 2018) Allergic Rhinitis: Developing Drug Products for Treatment Guidance for Industry</a></p><p><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/contents-complete-submission-threshold-analyses-and-human-factors-submissions-drug-and-biologic">(CDER 2018) Draft Guidance: Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications </a></p><p><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/nonallergic-rhinitis-developing-drug-products-treatment">(September 2018) Nonallergic Rhinitis: Developing Drug Products for Treatment</a></p><p><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applying-human-factors-and-usability-engineering-medical-devices">(CDER 2016) Applying Human Factors and Usability Engineering to Medical Devices – Guidance for Industry and Food and Drug Administration Staff</a></p><p>The FDA’s current thinking and expectations on how to develop generic drug products therapeutically equivalent to specific reference listed drugs is reflected in the following <a href="https://www.fda.gov/drugs/guidances-drugs/product-specific-guidances-generic-drug-development" target="_blank" rel="noopener">Product-Specific Guidances</a>:</p><p class="p1"><a href="https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210884.pdf">(CDER<span class="Apple-converted-space"> </span>2020) Draft Guidance for Sumatriptan, Nasal, Spray</a></p><p class="p2"><a href="https://www.accessdata.fda.gov/drugsatfda_docs/psg/beclomethasone%2520dipropionate%2520inhalation%2520aerosol%2520metered%2520nda%2520207921%2520psg%2520page%2520rc%2520may%25202019.pdf">(CDER 2019) Draft Guidance on Beclomethasone Dipropionate (Aerosol, Metered; Inhalation)</a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020746.pdf" target="_blank" rel="noopener"><span style="font-weight: 400;">(CDER 20</span><span style="font-weight: 400;">19</span><span style="font-weight: 400;">) Draft Guidance on Budesonide (Spray, Metered; Nasal)</span></a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluticasone%20propionate%20nasal%20spray%20NDA%20020121%20RV%2002-2019.pdf" target="_blank" rel="noopener"><span style="font-weight: 400;">(CDER 2019) Draft Guidance on Fluticasone Furoate (Metered, Spray; Nasal)</span></a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluticasone%20propionate%20nasal%20spray%20NDA%20020121%20RV%2002-2019.pdf" target="_blank" rel="noopener"><span style="font-weight: 400;">(CDER 2019) Draft Guidance on Fluticasone Propionate (Powder; Inhalation)</span></a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208799.pdf" target="_blank" rel="noopener"><span style="font-weight: 400;">(CDER 2019) Draft Guidance on Fluticasone Propionate; Salmeterol Xinafoate (Aerosol, Metered; Inhalation)</span></a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202236.PDF" target="_blank" rel="noopener"><span style="font-weight: 400;">(CDER 2019) Draft Guidance on Azelastine Hydrochloride and Fluticasone Propionate (Spray, Metered; Nasal)</span></a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluticasone%20propionate%20nasal%20spray%20NDA%20020121%20RV%2002-2019.pdf" target="_blank" rel="noopener"><span style="font-weight: 400;">(CDER 2019) Draft Guidance on Fluticasone Propionate (Metered, Spray; Nasal)</span></a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mometasone%20furoate%20nasal%20spray%20NDA%20020762%20RV%2002-2019.pdf" target="_blank" rel="noopener"><span style="font-weight: 400;">(CDER 2019) Draft Guidance on Mometasone Furoate Monohydrate (Metered, Spray; Nasal)</span></a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020468.pdf" target="_blank" rel="noopener"><span style="font-weight: 400;">(CDER 2019) Draft Guidance on Triamcinolone Acetonide (Metered, Spray; Nasal) </span></a> <span style="font-weight: 400;">Recommended Oct 2016; Revised Feb 2019, Jun 2020</span></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/psg/psg_208799.pdf"><span style="font-weight: 400;">(CDER 2019) Draft Guidance on Fluticasone Propionate and Salmeterol Xinafoate (Powder; Inhalation)</span></a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020148.pdf" target="_blank" rel="noopener"><span style="font-weight: 400;">(CDER 2019), Draft Guidance for Dihydroergotamine Mesylate, Nasal, Spray, Metered</span></a></p><p><a href="https://www.accessdata.fda.gov/scripts/cder/psg/index.cfm?event=Home.Letter&searchLetter=T" target="_blank" rel="noopener"><span style="font-weight: 400;">(CDER 2018) Draft Guidance for Talc, Inhalation, Aerosol, Metered</span></a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/psg/Zolmitriptan_Nasal%20spray_NDA%20021450_RV%20Oct%202018.pdf" target="_blank" rel="noopener"><span style="font-weight: 400;">CDER 2018), Draft Guidance for Zolmitriptan, Nasal, Spray</span></a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/psg/Azelastine%20HCl_nasal%20metered%20spray_NDA%20022203_RC08-17.pdf" target="_blank" rel="noopener"><span style="font-weight: 400;">(CDER 2019) Draft Guidance on Beclomethasone Dipropionate (Aerosol, Metered; Nasal)</span></a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/psg/Azelastine%20hydrochloride%3B%20Fluticasone%20propionate%20nasal%20metered%20spray%20NDA%20202236%20PSG%20Page%20RV%2002-2019.pdf" target="_blank" rel="noopener"><span style="font-weight: 400;">(CDER 2017) Draft Guidance on Azelastine Hydrochloride (Metered Spray; Nasal)</span></a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluticasone%20proprionate_inhalation%20powder_NDA%20020833_RC10-17.pdf" target="_blank" rel="noopener"><span style="font-weight: 400;">(CDER 2017) Draft Guidance on Fluticasone Propionate (Powder; Inhalation)</span></a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mometasone%20furoate_inhalation%20powder_NDA%20021067_RC08-17.pdf" target="_blank" rel="noopener"><span style="font-weight: 400;">(CDER 2017) Draft Guidance on Mometasone Furoate (Powder; Inhalation)</span></a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021936.pdf" target="_blank" rel="noopener"><span style="font-weight: 400;">(CDER 20</span><span style="font-weight: 400;">17</span><span style="font-weight: 400;">) Draft Guidance on Tiotropium Bromide (Powder; Inhalation)</span></a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/psg/Naloxone%20hydrochloride_%20nasal%20spray_%20NDA%20208411_RC04-17.pdf" target="_blank" rel="noopener"><span style="font-weight: 400;">(CDER 2017), Draft Guidance for Naloxone Hydrochloride, Nasal, Spray</span></a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/psg/Buprenorphine%20Hcl;%20Naloxone%20Hcl_sublingual%20tablet_RLD%20204242_RV12-16.pdf" target="_blank" rel="noopener"><span style="font-weight: 400;">(CDER 2016), Draft Guidance for Buprenorphine Hydrochloride; Naloxone Hydrochloride, Oral, Sublingual Tablet</span></a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020503.pdf" target="_blank" rel="noopener"><span style="font-weight: 400;">(CDER 2016) Draft Guidance on Albuterol Sulfate (Aerosol, Metered; Inhalation)</span></a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/psg/Budesonide_inhalation%20powder_RLD%2021949_RC12-16.pdf" target="_blank" rel="noopener"><span style="font-weight: 400;">(December 2016) Draft Guidance on Budesonide (Powder; Inhalation)</span></a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/psg/olopatadine%20hcl_nasal%20metered%20spray_rld%20021861_rc09-16.pdf" target="_blank" rel="noopener"><span style="font-weight: 400;">(CDER 2016) Draft Guidance on Olopatadine Hydrochloride (Metered Spray; Nasal)</span></a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/psg/Umeclidinium%20bromide_inhalation%20powder_RLD%20205382_RC09-16.pdf" target="_blank" rel="noopener"><span style="font-weight: 400;">(CDER 2016) Draft Guidance on Umeclidinium Bromide (Powder; Inhalation)</span></a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203975.pdf" target="_blank" rel="noopener"><span style="font-weight: 400;">(CDER 2020) Draft Guidance on Umeclidinium Bromide and Vilanterol Trifenatate (Powder; Inhalation)</span></a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluticasone%20furoate_inhalation%20powder_RLD%20205625_RC04-16.pdf" target="_blank" rel="noopener"><span style="font-weight: 400;">(CDER 2016) Draft Guidance on Fluticasone Furoate (Powder; Inhalation)</span></a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluticasone%20furoate;%20Vilanterol%20trif_inhal_%20pow_204275_RC04-16.pdf" target="_blank" rel="noopener"><span style="font-weight: 400;">(CDER 2016) Draft Guidance on Fluticasone Furoate; Vilanterol Trifenatate (Powder; Inhalation)</span></a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/psg/Indacaterol%20maleate_inhalation%20powder_RLD%2022383_RC04-16.pdf" target="_blank" rel="noopener"><span style="font-weight: 400;">(CDER 2016) Draft Guidance on Indacaterol Maleate (Powder; Inhalation)</span></a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mometasone%20furoate_Metered%20aerosol%20inhalation_RLD%20205641_RC04-16.pdf" target="_blank" rel="noopener"><span style="font-weight: 400;">(CDER 2016) Draft Guidance on Mometasone Furoate (Aerosol; Metered; Inhalation)</span></a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mometasone%20furoate%20nasal%20spray%20NDA%20020762%20RV%2002-2019.pdf" target="_blank" rel="noopener"><span style="font-weight: 400;">CDER 2015) Draft Guidance on Mometasone Furoate Monohydrate (Metered, Spray; Nasal) </span></a><span style="font-weight: 400;">Recommended Sept 2015; Revised Feb 2019</span></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021658.pdf" target="_blank" rel="noopener"><span style="font-weight: 400;">(CDER 2016) Draft Guidance on Ciclesonide (Aerosol; Metered; Inhalation)</span></a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/psg/formoterol%20fumarate_mometasone%20furoate_inhalation%20aerosol_rld%20022518_rc01-16.pdf" target="_blank" rel="noopener"><span style="font-weight: 400;">(CDER 2016) Draft Guidance on Formoterol Fumarate; Mometasone Furoate (Aerosol; Metered; Inhalation)</span></a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mometasone%20furoate_inhalation%20powder_NDA%20021067_RC08-17.pdf" target="_blank" rel="noopener"><span style="font-weight: 400;">CDER 2017) Draft Guidance on Mometasone Furoate (Powder; inhalation)</span></a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/psg/aclidinium%20bromide_inhalation%20powder_202450_rc09-15.pdf" target="_blank" rel="noopener"><span style="font-weight: 400;">(CDER 2015) Draft Guidance on Aclidinium Bromide (Powder, Metered; Inhalation)</span></a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210595.pdf" target="_blank" rel="noopener"><span style="font-weight: 400;">(CDER 2022) Draft Guidance on Aclidinium Bromide; Formoterol Fumarate (Powder, Metered; Inhalation)</span></a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluticasone%20propionate_nasal%20spray_205434_RC09-15.pdf" target="_blank" rel="noopener"><span style="font-weight: 400;">(CDER 2015) Draft Guidance on Fluticasone Propionate (OTC; Metered, Spray; Nasal)</span></a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/psg/Formoterol%20fumarate_Inhalation%20powder_020831_RC09-15.pdf" target="_blank" rel="noopener"><span style="font-weight: 400;">(CDER 2015) Draft Guidance on Formoterol Fumarate (Powder; Inhalation)</span></a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021730.pdf" target="_blank" rel="noopener"><span style="font-weight: 400;">(CDER 2015) Draft Guidance on Levalbuterol Tartrate (Aerosol, Metered; Inhalation)</span></a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ipratropium%20bromide_MDI_021527_RC03-15.pdf" target="_blank" rel="noopener"><span style="font-weight: 400;">(CDER 2015) Draft Guidance on Ipratropium Bromide (Aerosol, Metered; Inhalation)</span></a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/psg/Budesonide%20and%20Formoterol%20fumarate%20dihydrate_MDI_021929_RC06-15.pdf" target="_blank" rel="noopener"><span style="font-weight: 400;">(CDER 2015) Draft Guidance on Budesonide; Formoterol Fumarate Dihydrate (Aerosol; Metered; Inhalation)</span></a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208799.pdf" target="_blank" rel="noopener"><span style="font-weight: 400;">(CDER 2013) Draft Guidance on Fluticasone Propionate; Salmeterol Xinafoate (Powder/inhalation)</span></a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/psg/Budesonide_Inhalation_Sus_20929_RC_09-12.pdf" target="_blank" rel="noopener"><span style="font-weight: 400;">(CDER 2012) Draft Guidance on Budesonide (Suspension / Inhalation)</span></a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciclesonide%20Nasal%20Aerosol%20202129%20RC09-12.pdf" target="_blank" rel="noopener"><span style="font-weight: 400;">(CDER 2012) Draft Guidance on Ciclesonide (Aerosol, Metered/nasal)</span></a></p></div></div></div><div class="jet-accordion__item jet-toggle jet-toggle-move-up-effect "><div id="#EuropeanMedicinesAgency&EuropeanDirectoratefortheQualityofMedicines&HealthCare" class="jet-toggle__control elementor-menu-anchor" data-toggle="3" role="button" tabindex="0" aria-controls="jet-toggle-content-1733" aria-expanded="false" data-template-id="false"><div class="jet-toggle__label-icon jet-toggle-icon-position-left"><span class="jet-toggle__icon icon-normal jet-tabs-icon"><i class="fas fa-plus"></i></span><span class="jet-toggle__icon icon-active jet-tabs-icon"><i class="fas fa-minus"></i></span></div><div class="jet-toggle__label-text">European Medicines Agency & European Directorate for the Quality of Medicines & HealthCare</div></div><div id="jet-toggle-content-1733" class="jet-toggle__content" data-toggle="3" role="region" data-template-id="false"><div class="jet-toggle__content-inner"><p><img src="https://www.proveris.com/wp-content/plugins/lazy-load/images/1x1.trans.gif" data-lazy-src="https://www.proveris.com/wp-content/uploads/2021/03/EMA-EDQA-Logos_760p-x-286p-300x113.jpg" decoding="async" class="alignnone wp-image-3616 size-medium" alt width="300" height="113" srcset="https://www.proveris.com/wp-content/uploads/2021/03/EMA-EDQA-Logos_760p-x-286p-300x113.jpg 300w, https://www.proveris.com/wp-content/uploads/2021/03/EMA-EDQA-Logos_760p-x-286p.jpg 762w" sizes="(max-width: 300px) 100vw, 300px"><noscript><img decoding="async" class="alignnone wp-image-3616 size-medium" src="https://www.proveris.com/wp-content/uploads/2021/03/EMA-EDQA-Logos_760p-x-286p-300x113.jpg" alt="" width="300" height="113" srcset="https://www.proveris.com/wp-content/uploads/2021/03/EMA-EDQA-Logos_760p-x-286p-300x113.jpg 300w, https://www.proveris.com/wp-content/uploads/2021/03/EMA-EDQA-Logos_760p-x-286p.jpg 762w" sizes="(max-width: 300px) 100vw, 300px" /></noscript></p><p class="p1">The European Medicines Agency (EMA) works with the European Directorate for the Quality of Medicines and HealthCare (EDQM), a directorate of the Council of Europe on matters aimed at ensuring the quality of medicines and protection of public health.</p><p class="p3"><b>European Medicines Agency</b></p><p class="p1"><span class="s1">Guidance applicable to </span>Orally Inhaled and Nasal Drug Products:</p><p class="p4"><a href="https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-pharmaceutical-quality-inhalation-nasal-products_en.pdf">(June 2006) Guideline on The Pharmaceutical Quality of Inhalation and Nasal Products </a></p><p class="p4"><a href="https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-requirements-clinical-documentation-orally-inhaled-products-oip-including-requirements_en.pdf">(January 2009) Guideline on The Requirements for Clinical Documentation for Orally Inhaled Products (OIP) Including the Requirements for Demonstration of Therapeutic Equivalence Between Two Inhaled Products for Use in The Treatment of Asthma and Chronic Obstructive Pulmonary Disease (COPD) In Adults and For Use in The Treatment of Asthma in Children and Adolescents</a></p><p class="p1"><a href="https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-requirements-clinical-documentation-orally-inhaled-products-oip_en.pdf">(June 2017) Concept Paper on Revision of the Guideline on the Requirements for Clinical Documentation for Orally Inhaled Products (OIP) Including the Requirements for Demonstration of Therapeutic Equivalence Between Two Inhaled Products for Use in the Treatment of Asthma and Chronic Obstructive Pulmonary Disease (COPD) in Adults and for the Treatment of Asthma in Children and Adolescents</a></p><p class="p3"><b>European Directorate for the Quality of Medicines & HealthCare</b></p><p class="p5">Monographs applicable to Orally Inhaled and Nasal Drug Products from <span class="s1">The European Pharmacopoeia* 2019,10</span><span class="s2"><sup>th</sup></span><span class="s1"> Edition</span>, published by <span class="s1">EDQM:</span></p><p class="p6">Nasal Preparations, Dosage Forms 0676, European Pharmacopoeia: 2019 10<span class="s3"><sup>th </sup></span>Edition (10.3) 01/2021:0676, Pages 4823-4825 (for details, <a href="https://www.proveris.com/contact-us/"><span class="s4">contact us</span></a><span class="s5">)</span></p><div class="page" title="Page 1"><div class="section"><div class="layoutArea"><div class="column"><p>Inhalation Preparations, <span style="font-size: 1rem;">Dosage Forms 0671 European Pharmacopoeia: 2019 10</span><span class="s3" style="font-size: 1rem;"><sup>th </sup></span><span style="font-size: 1rem;">Edition (10.5) 07/2021:0671, Pages 5706-5711 (for details, </span><a style="font-size: 1rem;" href="https://www.proveris.com/contact-us/"><span class="s4">contact us</span></a><span class="s5" style="font-size: 1rem;">)</span></p></div></div></div></div><p class="p8"><span class="s1">*The European Pharmacopoeia</span>, published by <span class="s1">EDQM,</span> provides a legal and scientific reference for the quality control of medicines. All producers of medicines and substances for pharmaceutical must follow these standards when applying to the EMA and include reference to the monographs in the quality part of their applications.</p><p class="p8">The Council of Europe has 38 member states and 30 observers of which 6 are European countries and 22 are non-European countries. The Taiwan Food and Drug Administration (TFDA) of the Ministry of Health and Welfare and the World Health Organization (WHO) are also observers.</p></div></div></div><div class="jet-accordion__item jet-toggle jet-toggle-move-up-effect "><div id="jet-toggle-control-1734" class="jet-toggle__control elementor-menu-anchor" data-toggle="4" role="button" tabindex="0" aria-controls="jet-toggle-content-1734" aria-expanded="false" data-template-id="false"><div class="jet-toggle__label-icon jet-toggle-icon-position-left"><span class="jet-toggle__icon icon-normal jet-tabs-icon"><i class="fas fa-plus"></i></span><span class="jet-toggle__icon icon-active jet-tabs-icon"><i class="fas fa-minus"></i></span></div><div class="jet-toggle__label-text">Medicines and Healthcare Products Regulatory Agency (MHRA), UK</div></div><div id="jet-toggle-content-1734" class="jet-toggle__content" data-toggle="4" role="region" data-template-id="false"><div class="jet-toggle__content-inner"><p><img src="https://www.proveris.com/wp-content/plugins/lazy-load/images/1x1.trans.gif" data-lazy-src="https://www.proveris.com/wp-content/uploads/2021/03/MHRA_300p-x-200p-300x158.jpg" loading="lazy" decoding="async" class="alignnone wp-image-3620 size-medium" alt width="300" height="158" srcset="https://www.proveris.com/wp-content/uploads/2021/03/MHRA_300p-x-200p-300x158.jpg 300w, https://www.proveris.com/wp-content/uploads/2021/03/MHRA_300p-x-200p.jpg 380w" sizes="(max-width: 300px) 100vw, 300px"><noscript><img loading="lazy" decoding="async" class="alignnone wp-image-3620 size-medium" src="https://www.proveris.com/wp-content/uploads/2021/03/MHRA_300p-x-200p-300x158.jpg" alt="" width="300" height="158" srcset="https://www.proveris.com/wp-content/uploads/2021/03/MHRA_300p-x-200p-300x158.jpg 300w, https://www.proveris.com/wp-content/uploads/2021/03/MHRA_300p-x-200p.jpg 380w" sizes="(max-width: 300px) 100vw, 300px" /></noscript></p><p class="p1">In the UK, the Medicines and Healthcare products Regulatory Agency is an executive agency of the Department of Health and Social Care responsible for ensuring that medicines and medical devices work and are acceptably safe.</p><p class="p2"><a href="https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/957090/Software_flow_chart_Ed_1-07b-UKCA__002__FINAL.pdf">(June 2018) Guidance: Medical device stand-alone Software Including Apps (including IVDMDs)</a></p><p class="p2"><a href="https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/960905/Human_Factors_Medical_Devices.pdf">(September 2017) Human Factors and Usability Engineering – Guidance for Medical Devices Including Drug-device Combination Products</a></p><p class="p5"><a href="https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency">MHRA website</a></p></div></div></div><div class="jet-accordion__item jet-toggle jet-toggle-move-up-effect "><div id="jet-toggle-control-1735" class="jet-toggle__control elementor-menu-anchor" data-toggle="5" role="button" tabindex="0" aria-controls="jet-toggle-content-1735" aria-expanded="false" data-template-id="false"><div class="jet-toggle__label-icon jet-toggle-icon-position-left"><span class="jet-toggle__icon icon-normal jet-tabs-icon"><i class="fas fa-plus"></i></span><span class="jet-toggle__icon icon-active jet-tabs-icon"><i class="fas fa-minus"></i></span></div><div class="jet-toggle__label-text">The National Medical Products Administration</div></div><div id="jet-toggle-content-1735" class="jet-toggle__content" data-toggle="5" role="region" data-template-id="false"><div class="jet-toggle__content-inner"><p><img src="https://www.proveris.com/wp-content/plugins/lazy-load/images/1x1.trans.gif" data-lazy-src="https://www.proveris.com//wp-content/uploads/2019/09/logo-300x72.png" loading="lazy" decoding="async" class="alignnone wp-image-1826 size-medium" alt width="300" height="72" srcset="https://www.proveris.com/wp-content/uploads/2019/09/logo-300x72.png 300w, https://www.proveris.com/wp-content/uploads/2019/09/logo.png 650w" sizes="(max-width: 300px) 100vw, 300px"><noscript><img loading="lazy" decoding="async" class="alignnone wp-image-1826 size-medium" src="https://www.proveris.com//wp-content/uploads/2019/09/logo-300x72.png" alt="" width="300" height="72" srcset="https://www.proveris.com/wp-content/uploads/2019/09/logo-300x72.png 300w, https://www.proveris.com/wp-content/uploads/2019/09/logo.png 650w" sizes="(max-width: 300px) 100vw, 300px" /></noscript></p><p>In China, the National Medical Products Administration (NMPA) is the Chinese agency for regulating drugs and medical devices (formerly the China Food and Drug Administration or CFDA). Its responsibilities include drafting laws and regulations for drugs, medical devices, and cosmetics, as well as establishing medical device standards and classification systems.</p><p><a href="http://www.nmpa.gov.cn/" target="_blank" rel="noopener"><span class="elementor-icon-list-text">NMPA Website</span></a></p></div></div></div><div class="jet-accordion__item jet-toggle jet-toggle-move-up-effect "><div id="jet-toggle-control-1736" class="jet-toggle__control elementor-menu-anchor" data-toggle="6" role="button" tabindex="0" aria-controls="jet-toggle-content-1736" aria-expanded="false" data-template-id="false"><div class="jet-toggle__label-icon jet-toggle-icon-position-left"><span class="jet-toggle__icon icon-normal jet-tabs-icon"><i class="fas fa-plus"></i></span><span class="jet-toggle__icon icon-active jet-tabs-icon"><i class="fas fa-minus"></i></span></div><div class="jet-toggle__label-text">Brazil Health Surveillance Agency (ANVISA)</div></div><div id="jet-toggle-content-1736" class="jet-toggle__content" data-toggle="6" role="region" data-template-id="false"><div class="jet-toggle__content-inner"><p><img src="https://www.proveris.com/wp-content/plugins/lazy-load/images/1x1.trans.gif" data-lazy-src="https://www.proveris.com//wp-content/uploads/2019/09/anvisa-logo-300x69.png" loading="lazy" decoding="async" class="alignnone wp-image-1827 size-medium" alt width="300" height="69" srcset="https://www.proveris.com/wp-content/uploads/2019/09/anvisa-logo-300x69.png 300w, https://www.proveris.com/wp-content/uploads/2019/09/anvisa-logo-768x176.png 768w, https://www.proveris.com/wp-content/uploads/2019/09/anvisa-logo-1024x235.png 1024w" sizes="(max-width: 300px) 100vw, 300px"><noscript><img loading="lazy" decoding="async" class="alignnone wp-image-1827 size-medium" src="https://www.proveris.com//wp-content/uploads/2019/09/anvisa-logo-300x69.png" alt="" width="300" height="69" srcset="https://www.proveris.com/wp-content/uploads/2019/09/anvisa-logo-300x69.png 300w, https://www.proveris.com/wp-content/uploads/2019/09/anvisa-logo-768x176.png 768w, https://www.proveris.com/wp-content/uploads/2019/09/anvisa-logo-1024x235.png 1024w" sizes="(max-width: 300px) 100vw, 300px" /></noscript></p><p>In Brazil, the Health Regulatory Agency, Anvisa, executes sanitary control of the production, marketing and use of products and services subject to health regulation, including related environments, processes, ingredients and technologies.</p><p><a href="http://portal.anvisa.gov.br/english" target="_blank" rel="noopener"><span class="elementor-icon-list-text">ANVISA Website</span></a></p></div></div></div><div class="jet-accordion__item jet-toggle jet-toggle-move-up-effect "><div id="jet-toggle-control-1737" class="jet-toggle__control elementor-menu-anchor" data-toggle="7" role="button" tabindex="0" aria-controls="jet-toggle-content-1737" aria-expanded="false" data-template-id="false"><div class="jet-toggle__label-icon jet-toggle-icon-position-left"><span class="jet-toggle__icon icon-normal jet-tabs-icon"><i class="fas fa-plus"></i></span><span class="jet-toggle__icon icon-active jet-tabs-icon"><i class="fas fa-minus"></i></span></div><div class="jet-toggle__label-text">Government of Canada Drug Products</div></div><div id="jet-toggle-content-1737" class="jet-toggle__content" data-toggle="7" role="region" data-template-id="false"><div class="jet-toggle__content-inner"><p><img src="https://www.proveris.com/wp-content/plugins/lazy-load/images/1x1.trans.gif" data-lazy-src="https://www.proveris.com/wp-content/uploads/2021/03/HealthCanada-400p-x-105p-300x79.jpg" loading="lazy" decoding="async" class="alignnone wp-image-3624 size-medium" alt width="300" height="79" srcset="https://www.proveris.com/wp-content/uploads/2021/03/HealthCanada-400p-x-105p-300x79.jpg 300w, https://www.proveris.com/wp-content/uploads/2021/03/HealthCanada-400p-x-105p.jpg 400w" sizes="(max-width: 300px) 100vw, 300px"><noscript><img loading="lazy" decoding="async" class="alignnone wp-image-3624 size-medium" src="https://www.proveris.com/wp-content/uploads/2021/03/HealthCanada-400p-x-105p-300x79.jpg" alt="" width="300" height="79" srcset="https://www.proveris.com/wp-content/uploads/2021/03/HealthCanada-400p-x-105p-300x79.jpg 300w, https://www.proveris.com/wp-content/uploads/2021/03/HealthCanada-400p-x-105p.jpg 400w" sizes="(max-width: 300px) 100vw, 300px" /></noscript></p><p>In Canada, Health Canada reviews drug products to assess their safety, efficacy and quality.</p><p class="p1"><a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/chemical-entity-products-quality/guidance-industry-pharmaceutical-quality-inhalation-nasal-products.html">(October 2001) Guidance for Industry – Pharmaceutical Quality of Inhalation and Nasal Products</a></p><p class="p1"><a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/inhalers/guidance-establish-equivalence-relative-potency-safety-efficacy-second-entry-short-acting-beta2-agonist-metered-dose-inhaler.html">(April 1999) Guidance to Establish Equivalence or Relative Potency of Safety and Efficacy of a Second Entry Short-Acting Beta2-Agonist Metered Dose Inhaler (MDI)</a></p><p class="p1"><a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/inhaled-corticosteroid-profile.html">(October 2018) Guidance Document: Data Requirements for Safety and Effectiveness of Subsequent Entry Inhaled Corticosteroid Products Used for the Treatment of Asthma – Summary</a></p><p><img src="https://www.proveris.com/wp-content/plugins/lazy-load/images/1x1.trans.gif" data-lazy-src="https://www.proveris.com/wp-content/uploads/2021/03/StandardsCouncil-ofCanada_400p-x-95p-300x71.png" loading="lazy" decoding="async" class="alignnone size-medium wp-image-3625" alt width="300" height="71" srcset="https://www.proveris.com/wp-content/uploads/2021/03/StandardsCouncil-ofCanada_400p-x-95p-300x71.png 300w, https://www.proveris.com/wp-content/uploads/2021/03/StandardsCouncil-ofCanada_400p-x-95p.png 400w" sizes="(max-width: 300px) 100vw, 300px"><noscript><img loading="lazy" decoding="async" class="alignnone size-medium wp-image-3625" src="https://www.proveris.com/wp-content/uploads/2021/03/StandardsCouncil-ofCanada_400p-x-95p-300x71.png" alt="" width="300" height="71" srcset="https://www.proveris.com/wp-content/uploads/2021/03/StandardsCouncil-ofCanada_400p-x-95p-300x71.png 300w, https://www.proveris.com/wp-content/uploads/2021/03/StandardsCouncil-ofCanada_400p-x-95p.png 400w" sizes="(max-width: 300px) 100vw, 300px" /></noscript></p><p class="p1">The Standards Council of Canada is the approval body for <span class="s1">national standards.</span></p><p class="p3"><span class="s2"><a href="https://www.scc.ca/en/standardsdb/standards/18762">(August 2011) CAN/CSA-Z264.1-02 (R2011) Spacers and Holding Chambers for Use with Metered-Dose Inhalers</a></span></p><p> </p></div></div></div></div></div></div></div><section class="elementor-section elementor-inner-section elementor-element elementor-element-b2fa220 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="b2fa220" data-element_type="section" data-settings="{"jet_parallax_layout_list":[{"jet_parallax_layout_image":{"url":"","id":"","size":""},"_id":"ab301de","jet_parallax_layout_image_tablet":{"url":"","id":"","size":""},"jet_parallax_layout_image_mobile":{"url":"","id":"","size":""},"jet_parallax_layout_speed":{"unit":"%","size":50,"sizes":[]},"jet_parallax_layout_type":"scroll","jet_parallax_layout_direction":null,"jet_parallax_layout_fx_direction":null,"jet_parallax_layout_z_index":"","jet_parallax_layout_bg_x":50,"jet_parallax_layout_bg_x_tablet":"","jet_parallax_layout_bg_x_mobile":"","jet_parallax_layout_bg_y":50,"jet_parallax_layout_bg_y_tablet":"","jet_parallax_layout_bg_y_mobile":"","jet_parallax_layout_bg_size":"auto","jet_parallax_layout_bg_size_tablet":"","jet_parallax_layout_bg_size_mobile":"","jet_parallax_layout_animation_prop":"transform","jet_parallax_layout_on":["desktop","tablet"]}]}"><div class="elementor-container elementor-column-gap-default"><div class="elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-9bfc730" data-id="9bfc730" data-element_type="column"><div class="elementor-widget-wrap elementor-element-populated"><div class="elementor-element elementor-element-1b83aa2 elementor-widget elementor-widget-spacer" data-id="1b83aa2" data-element_type="widget" data-widget_type="spacer.default"><div class="elementor-widget-container"><div class="elementor-spacer"><div class="elementor-spacer-inner"></div></div></div></div><div class="elementor-element elementor-element-36c092e elementor-widget elementor-widget-text-editor" data-id="36c092e" data-element_type="widget" data-widget_type="text-editor.default"><div class="elementor-widget-container"><div class="page" title="Page 1"><div class="layoutArea"><div class="column"><p>Regulatory guidelines for in vitro testing of OINDPs include general descriptions for characterizing OINDP performance under fixed laboratory conditions to determine certain end-point oriented critical quality attributes (CQA) that drive product quality. Proveris instruments can perform these tests on a range of devices through the life of the device. Below are some of the commonly accepted tests:</p></div></div></div></div></div></div></div></div></section><section class="elementor-section elementor-inner-section elementor-element elementor-element-502b9cb elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="502b9cb" data-element_type="section" data-settings="{"jet_parallax_layout_list":[{"jet_parallax_layout_image":{"url":"","id":"","size":""},"_id":"1be002a","jet_parallax_layout_image_tablet":{"url":"","id":"","size":""},"jet_parallax_layout_image_mobile":{"url":"","id":"","size":""},"jet_parallax_layout_speed":{"unit":"%","size":50,"sizes":[]},"jet_parallax_layout_type":"scroll","jet_parallax_layout_direction":null,"jet_parallax_layout_fx_direction":null,"jet_parallax_layout_z_index":"","jet_parallax_layout_bg_x":50,"jet_parallax_layout_bg_x_tablet":"","jet_parallax_layout_bg_x_mobile":"","jet_parallax_layout_bg_y":50,"jet_parallax_layout_bg_y_tablet":"","jet_parallax_layout_bg_y_mobile":"","jet_parallax_layout_bg_size":"auto","jet_parallax_layout_bg_size_tablet":"","jet_parallax_layout_bg_size_mobile":"","jet_parallax_layout_animation_prop":"transform","jet_parallax_layout_on":["desktop","tablet"]}]}"><div class="elementor-container elementor-column-gap-default"><div class="elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-f5ea8b7" data-id="f5ea8b7" data-element_type="column"><div class="elementor-widget-wrap elementor-element-populated"><div class="elementor-element elementor-element-8255d49 elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list" data-id="8255d49" data-element_type="widget" data-widget_type="icon-list.default"><div class="elementor-widget-container"><ul class="elementor-icon-list-items"><li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <i aria-hidden="true" class="fas fa-chevron-right"></i> </span> <span class="elementor-icon-list-text">Single Actuation Container (SAC) Through Life</span></li><li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <i aria-hidden="true" class="fas fa-chevron-right"></i> </span> <span class="elementor-icon-list-text">Aerodynamic Particle Size Distribution (APSD) by Cascade Impaction (NGI, ACI)</span></li><li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <i aria-hidden="true" class="fas fa-chevron-right"></i> </span> <span class="elementor-icon-list-text">Spray Pattern</span></li><li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <i aria-hidden="true" class="fas fa-chevron-right"></i> </span> <span class="elementor-icon-list-text">Plume Geometry</span></li><li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <i aria-hidden="true" class="fas fa-chevron-right"></i> </span> <span class="elementor-icon-list-text">Priming/Re-priming</span></li><li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <i aria-hidden="true" class="fas fa-chevron-right"></i> </span> <span class="elementor-icon-list-text">Delivered Dose Uniformity</span></li></ul></div></div></div></div><div class="elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-0aefb7c" data-id="0aefb7c" data-element_type="column"><div class="elementor-widget-wrap elementor-element-populated"><div class="elementor-element elementor-element-f856f45 elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list" data-id="f856f45" data-element_type="widget" data-widget_type="icon-list.default"><div class="elementor-widget-container"><ul class="elementor-icon-list-items"><li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <i aria-hidden="true" class="fas fa-chevron-right"></i> </span> <span class="elementor-icon-list-text">Delivered Mass Uniformity</span></li><li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <i aria-hidden="true" class="fas fa-chevron-right"></i> </span> <span class="elementor-icon-list-text">Valve/Pump Delivery (Shot Weight)</span></li><li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <i aria-hidden="true" class="fas fa-chevron-right"></i> </span> <span class="elementor-icon-list-text">Drug Particle Size by Microscopy (Suspensions)</span></li><li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <i aria-hidden="true" class="fas fa-chevron-right"></i> </span> <span class="elementor-icon-list-text">Droplet Size Distribution (DSD) by Laser Diffraction</span></li><li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <i aria-hidden="true" class="fas fa-chevron-right"></i> </span> <span class="elementor-icon-list-text">Product Wasting for Through-Life Testing</span></li><li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <i aria-hidden="true" class="fas fa-chevron-right"></i> </span> <span class="elementor-icon-list-text">Inter-/Intra-container Through-Life Product Testing</span></li></ul></div></div></div></div></div></section></div></div></div></section><section class="elementor-section 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fa-home"></i> </span> <span class="elementor-icon-list-text">2 Cabot Road<br/>Hudson, MA 01749 U.S.A.</span></li><li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <i aria-hidden="true" class="fas fa-phone"></i> </span> <span class="elementor-icon-list-text">+1 508 460-8822 SALES SUPPORT</span></li><li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <i aria-hidden="true" class="fas fa-fax"></i> </span> <span class="elementor-icon-list-text">FAX +1 508 460-8942</span></li><li class="elementor-icon-list-item"> <a href="https://www.proveris.com//instrument-and-application-support-form/"> <span class="elementor-icon-list-icon"> <i aria-hidden="true" class="fas fa-wrench"></i> </span> <span class="elementor-icon-list-text">REQUEST INSTRUMENT & APPLICATION SUPPORT</span> </a></li></ul></div></div></div></div></div></section><section class="elementor-section elementor-top-section elementor-element elementor-element-ed9e4e2 elementor-section-height-min-height elementor-section-boxed elementor-section-height-default elementor-section-items-middle" data-id="ed9e4e2" data-element_type="section" 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