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class="elementor-widget-container"> <nav class="cpel-switcher__nav"><div class="cpel-switcher__toggle cpel-switcher__lang" onclick="this.classList.toggle('cpel-switcher__toggle--on')"><a lang="en-US" hreflang="en-US" href="https://firalismolecularprecision.com/regulatory-affairs/"><span class="cpel-switcher__code">EN</span><i class="cpel-switcher__icon fas fa-caret-down" aria-hidden="true"></i></a></div><ul class="cpel-switcher__list"><li class="cpel-switcher__lang"><a lang="fr-FR" hreflang="fr-FR" href="https://firalismolecularprecision.com/fr/affaires-reglementaires/"><span class="cpel-switcher__code">FR</span></a></li></ul></nav> </div> </div> </div> </div> </div> </div> </header> <div data-elementor-type="wp-page" data-elementor-id="17511" class="elementor elementor-17511"> <div class="elementor-element elementor-element-44e9836 e-flex e-con-boxed e-con e-parent" data-id="44e9836" data-element_type="container" data-settings="{"background_background":"classic"}"> <div class="e-con-inner"> <div class="elementor-element elementor-element-743f4a6 elementor-widget elementor-widget-heading" data-id="743f4a6" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h1 class="elementor-heading-title elementor-size-default">Regulatory Affairs</h1> </div> </div> <div class="elementor-element elementor-element-73fe1e8 elementor-widget elementor-widget-heading" data-id="73fe1e8" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h2 class="elementor-heading-title elementor-size-default">We empower clients to bring their IVD diagnostic kits to market with confidence and compliance.</h2> </div> </div> </div> </div> <div class="elementor-element elementor-element-01b8954 e-con-full e-flex e-con e-parent" data-id="01b8954" data-element_type="container" data-settings="{"background_background":"classic"}"> <div class="elementor-element elementor-element-2ff67a9 e-flex e-con-boxed e-con e-child" data-id="2ff67a9" data-element_type="container"> <div class="e-con-inner"> <div class="elementor-element elementor-element-fd936c2 elementor-invisible elementor-widget elementor-widget-text-editor" data-id="fd936c2" data-element_type="widget" data-settings="{"_animation":"fadeIn","_animation_delay":300}" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p>Navigating the regulatory landscape can be challenging, but our expertise makes it seamless. We stay updated with regulatory changes and ensure that all our documentation and processes support our clients’ regulatory submissions.</p><p>Our Regulatory Affairs department is committed to guiding our clients through the regulatory processes of both the EU and US markets, by providing support in CE marking or the FDA submission process.</p> </div> </div> </div> </div> </div> <div class="elementor-element elementor-element-48515b7 e-flex e-con-boxed e-con e-parent" data-id="48515b7" data-element_type="container"> <div class="e-con-inner"> <div class="elementor-element elementor-element-c33791e elementor-widget elementor-widget-heading" data-id="c33791e" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h2 class="elementor-heading-title elementor-size-default">WHAT WE DELIVER</h2> </div> </div> <div class="elementor-element elementor-element-e5bab6d elementor-widget-divider--view-line elementor-widget elementor-widget-divider" data-id="e5bab6d" data-element_type="widget" data-widget_type="divider.default"> <div class="elementor-widget-container"> <div class="elementor-divider"> <span class="elementor-divider-separator"> </span> </div> </div> </div> </div> </div> <div class="elementor-element elementor-element-fcb2034 e-flex e-con-boxed e-con e-parent" data-id="fcb2034" data-element_type="container"> <div class="e-con-inner"> <div class="elementor-element elementor-element-700510c e-con-full animated-slow e-flex elementor-invisible e-con e-child" data-id="700510c" data-element_type="container" data-settings="{"animation":"fadeIn","animation_delay":200}"> <div class="elementor-element elementor-element-d484ea9 elementor-view-default elementor-widget elementor-widget-icon" data-id="d484ea9" data-element_type="widget" data-widget_type="icon.default"> <div class="elementor-widget-container"> <div class="elementor-icon-wrapper"> <div class="elementor-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-far-file-alt" viewBox="0 0 384 512" xmlns="http://www.w3.org/2000/svg"><path d="M288 248v28c0 6.6-5.4 12-12 12H108c-6.6 0-12-5.4-12-12v-28c0-6.6 5.4-12 12-12h168c6.6 0 12 5.4 12 12zm-12 72H108c-6.6 0-12 5.4-12 12v28c0 6.6 5.4 12 12 12h168c6.6 0 12-5.4 12-12v-28c0-6.6-5.4-12-12-12zm108-188.1V464c0 26.5-21.5 48-48 48H48c-26.5 0-48-21.5-48-48V48C0 21.5 21.5 0 48 0h204.1C264.8 0 277 5.1 286 14.1L369.9 98c9 8.9 14.1 21.2 14.1 33.9zm-128-80V128h76.1L256 51.9zM336 464V176H232c-13.3 0-24-10.7-24-24V48H48v416h288z"></path></svg> </div> </div> </div> </div> <div class="elementor-element elementor-element-5f760e1 elementor-widget elementor-widget-heading" data-id="5f760e1" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h3 class="elementor-heading-title elementor-size-default">Regulatory Compliance Assurance</h3> </div> </div> <div class="elementor-element elementor-element-2764aab elementor-widget elementor-widget-text-editor" data-id="2764aab" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p>Ensuring compliance with relevant regulations such as the FDA in the US, the CE directive in the EU, and other national or international regulatory frameworks.</p> </div> </div> </div> <div class="elementor-element elementor-element-a5df8bb e-con-full animated-slow e-flex elementor-invisible e-con e-child" data-id="a5df8bb" data-element_type="container" data-settings="{"animation":"fadeIn","animation_delay":300}"> <div class="elementor-element elementor-element-dfe5594 elementor-view-default elementor-widget elementor-widget-icon" data-id="dfe5594" data-element_type="widget" data-widget_type="icon.default"> <div class="elementor-widget-container"> <div class="elementor-icon-wrapper"> <div class="elementor-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-far-clipboard" viewBox="0 0 384 512" xmlns="http://www.w3.org/2000/svg"><path d="M336 64h-80c0-35.3-28.7-64-64-64s-64 28.7-64 64H48C21.5 64 0 85.5 0 112v352c0 26.5 21.5 48 48 48h288c26.5 0 48-21.5 48-48V112c0-26.5-21.5-48-48-48zM192 40c13.3 0 24 10.7 24 24s-10.7 24-24 24-24-10.7-24-24 10.7-24 24-24zm144 418c0 3.3-2.7 6-6 6H54c-3.3 0-6-2.7-6-6V118c0-3.3 2.7-6 6-6h42v36c0 6.6 5.4 12 12 12h168c6.6 0 12-5.4 12-12v-36h42c3.3 0 6 2.7 6 6z"></path></svg> </div> </div> </div> </div> <div class="elementor-element elementor-element-056b0dd elementor-widget elementor-widget-heading" data-id="056b0dd" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h3 class="elementor-heading-title elementor-size-default">Risk Assessment</h3> </div> </div> <div class="elementor-element elementor-element-d2b9b73 elementor-widget elementor-widget-text-editor" data-id="d2b9b73" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p>Conducting thorough evaluations of risks associated with IVD diagnostic kits, including patient health risks, result accuracy, and user safety.</p> </div> </div> </div> <div class="elementor-element elementor-element-3c9a07d e-con-full animated-slow e-flex elementor-invisible e-con e-child" data-id="3c9a07d" data-element_type="container" data-settings="{"animation":"fadeIn","animation_delay":500}"> <div class="elementor-element elementor-element-ee1c703 elementor-view-default elementor-widget elementor-widget-icon" data-id="ee1c703" data-element_type="widget" data-widget_type="icon.default"> <div class="elementor-widget-container"> <div class="elementor-icon-wrapper"> <div class="elementor-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-far-check-circle" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M256 8C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 48c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m140.204 130.267l-22.536-22.718c-4.667-4.705-12.265-4.736-16.97-.068L215.346 303.697l-59.792-60.277c-4.667-4.705-12.265-4.736-16.97-.069l-22.719 22.536c-4.705 4.667-4.736 12.265-.068 16.971l90.781 91.516c4.667 4.705 12.265 4.736 16.97.068l172.589-171.204c4.704-4.668 4.734-12.266.067-16.971z"></path></svg> </div> </div> </div> </div> <div class="elementor-element elementor-element-e3d4e9b elementor-widget elementor-widget-heading" data-id="e3d4e9b" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h3 class="elementor-heading-title elementor-size-default">Process Validation</h3> </div> </div> <div class="elementor-element elementor-element-c40f1e4 elementor-widget elementor-widget-text-editor" data-id="c40f1e4" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p>Validating manufacturing, assembly, and quality control processes to ensure reliability and reproducibility of IVD kit results.</p> </div> </div> </div> <div class="elementor-element elementor-element-6e1b7a9 e-con-full animated-slow e-flex elementor-invisible e-con e-child" data-id="6e1b7a9" data-element_type="container" data-settings="{"animation":"fadeIn","animation_delay":600}"> <div class="elementor-element elementor-element-b1723f0 elementor-view-default elementor-widget elementor-widget-icon" data-id="b1723f0" data-element_type="widget" data-widget_type="icon.default"> <div class="elementor-widget-container"> <div class="elementor-icon-wrapper"> <div class="elementor-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-people-arrows" viewBox="0 0 576 512" xmlns="http://www.w3.org/2000/svg"><path d="M96,128A64,64,0,1,0,32,64,64,64,0,0,0,96,128Zm0,176.08a44.11,44.11,0,0,1,13.64-32L181.77,204c1.65-1.55,3.77-2.31,5.61-3.57A63.91,63.91,0,0,0,128,160H64A64,64,0,0,0,0,224v96a32,32,0,0,0,32,32V480a32,32,0,0,0,32,32h64a32,32,0,0,0,32-32V383.61l-50.36-47.53A44.08,44.08,0,0,1,96,304.08ZM480,128a64,64,0,1,0-64-64A64,64,0,0,0,480,128Zm32,32H448a63.91,63.91,0,0,0-59.38,40.42c1.84,1.27,4,2,5.62,3.59l72.12,68.06a44.37,44.37,0,0,1,0,64L416,383.62V480a32,32,0,0,0,32,32h64a32,32,0,0,0,32-32V352a32,32,0,0,0,32-32V224A64,64,0,0,0,512,160ZM444.4,295.34l-72.12-68.06A12,12,0,0,0,352,236v36H224V236a12,12,0,0,0-20.28-8.73L131.6,295.34a12.4,12.4,0,0,0,0,17.47l72.12,68.07A12,12,0,0,0,224,372.14V336H352v36.14a12,12,0,0,0,20.28,8.74l72.12-68.07A12.4,12.4,0,0,0,444.4,295.34Z"></path></svg> </div> </div> </div> </div> <div class="elementor-element elementor-element-7d4251c elementor-widget elementor-widget-heading" data-id="7d4251c" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h3 class="elementor-heading-title elementor-size-default">Clinical Study Support</h3> </div> </div> <div class="elementor-element elementor-element-dcabf6a elementor-widget elementor-widget-text-editor" data-id="dcabf6a" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p>Collaborating with clients to monitor and participate in clinical studies to assess IVD kit performance, including sensitivity, specificity, and diagnostic accuracy</p> </div> </div> </div> </div> </div> <div class="elementor-element elementor-element-86a8c4b e-flex e-con-boxed e-con e-parent" data-id="86a8c4b" data-element_type="container"> <div class="e-con-inner"> <div class="elementor-element elementor-element-7c0fba7 e-con-full animated-slow e-flex elementor-invisible e-con e-child" data-id="7c0fba7" data-element_type="container" data-settings="{"animation":"fadeIn","animation_delay":200}"> <div class="elementor-element elementor-element-dad5e04 elementor-view-default elementor-widget elementor-widget-icon" data-id="dad5e04" data-element_type="widget" data-widget_type="icon.default"> <div class="elementor-widget-container"> <div class="elementor-icon-wrapper"> <div class="elementor-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-tag" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M0 252.118V48C0 21.49 21.49 0 48 0h204.118a48 48 0 0 1 33.941 14.059l211.882 211.882c18.745 18.745 18.745 49.137 0 67.882L293.823 497.941c-18.745 18.745-49.137 18.745-67.882 0L14.059 286.059A48 48 0 0 1 0 252.118zM112 64c-26.51 0-48 21.49-48 48s21.49 48 48 48 48-21.49 48-48-21.49-48-48-48z"></path></svg> </div> </div> </div> </div> <div class="elementor-element elementor-element-7347e7a elementor-widget elementor-widget-heading" data-id="7347e7a" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h3 class="elementor-heading-title elementor-size-default">Labeling and Documentation</h3> </div> </div> <div class="elementor-element elementor-element-0ed46d4 elementor-widget elementor-widget-text-editor" data-id="0ed46d4" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p>Ensuring compliance with relevant regulations such as the FDA in the US, the CE directive in the EU, and other national or international regulatory frameworks.</p> </div> </div> </div> <div class="elementor-element elementor-element-1c5862c e-con-full animated-slow e-flex elementor-invisible e-con e-child" data-id="1c5862c" data-element_type="container" data-settings="{"animation":"fadeIn","animation_delay":300}"> <div class="elementor-element elementor-element-9715510 elementor-view-default elementor-widget elementor-widget-icon" data-id="9715510" data-element_type="widget" data-widget_type="icon.default"> <div class="elementor-widget-container"> <div class="elementor-icon-wrapper"> <div class="elementor-icon"> <svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 64 64"><path d="m54.029 24.157c0-12.216-9.913-22.029-22.029-22.029s-22.029 9.913-22.029 22.029c0 8.411 5.107 15.821 12.016 19.525l-2.003 18.524 12.016-8.01 12.016 8.01-2.003-18.524c7.009-3.705 12.016-11.114 12.016-19.525zm-22.029 20.026c-11.114 0-20.026-9.012-20.026-20.026 0-11.114 9.012-20.026 20.026-20.026s20.026 9.012 20.026 20.026a19.957 19.957 0 0 1 -20.026 20.026zm9.012-28.237 3.004 3.004-13.518 13.518-7.51-7.51 3.004-3.004 4.506 4.506z"></path></svg> </div> </div> </div> </div> <div class="elementor-element elementor-element-50c40fb elementor-widget elementor-widget-heading" data-id="50c40fb" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h3 class="elementor-heading-title elementor-size-default">Quality Verification</h3> </div> </div> <div class="elementor-element elementor-element-90e2c2a elementor-widget elementor-widget-text-editor" data-id="90e2c2a" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p>Establishing quality control systems to monitor IVD kit manufacturing, ensuring compliance with specifications and detecting potential quality issues.</p> </div> </div> </div> <div class="elementor-element elementor-element-b7b8f8e e-con-full animated-slow e-flex elementor-invisible e-con e-child" data-id="b7b8f8e" data-element_type="container" data-settings="{"animation":"fadeIn","animation_delay":500}"> <div class="elementor-element elementor-element-6aafac9 elementor-view-default elementor-widget elementor-widget-icon" data-id="6aafac9" data-element_type="widget" data-widget_type="icon.default"> <div class="elementor-widget-container"> <div class="elementor-icon-wrapper"> <div class="elementor-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-far-edit" viewBox="0 0 576 512" xmlns="http://www.w3.org/2000/svg"><path d="M402.3 344.9l32-32c5-5 13.7-1.5 13.7 5.7V464c0 26.5-21.5 48-48 48H48c-26.5 0-48-21.5-48-48V112c0-26.5 21.5-48 48-48h273.5c7.1 0 10.7 8.6 5.7 13.7l-32 32c-1.5 1.5-3.5 2.3-5.7 2.3H48v352h352V350.5c0-2.1.8-4.1 2.3-5.6zm156.6-201.8L296.3 405.7l-90.4 10c-26.2 2.9-48.5-19.2-45.6-45.6l10-90.4L432.9 17.1c22.9-22.9 59.9-22.9 82.7 0l43.2 43.2c22.9 22.9 22.9 60 .1 82.8zM460.1 174L402 115.9 216.2 301.8l-7.3 65.3 65.3-7.3L460.1 174zm64.8-79.7l-43.2-43.2c-4.1-4.1-10.8-4.1-14.8 0L436 82l58.1 58.1 30.9-30.9c4-4.2 4-10.8-.1-14.9z"></path></svg> </div> </div> </div> </div> <div class="elementor-element elementor-element-97c8a69 elementor-widget elementor-widget-heading" data-id="97c8a69" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h3 class="elementor-heading-title elementor-size-default">Change Management</h3> </div> </div> <div class="elementor-element elementor-element-4eb21f6 elementor-widget elementor-widget-text-editor" data-id="4eb21f6" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p>Managing changes throughout the IVD kit lifecycle, documenting changes, assessing their regulatory impact, and implementing them appropriately.</p> </div> </div> </div> <div class="elementor-element elementor-element-dce5360 e-con-full animated-slow e-flex elementor-invisible e-con e-child" data-id="dce5360" data-element_type="container" data-settings="{"animation":"fadeIn","animation_delay":600}"> <div class="elementor-element elementor-element-9d4b521 elementor-view-default elementor-widget elementor-widget-icon" data-id="9d4b521" data-element_type="widget" data-widget_type="icon.default"> <div class="elementor-widget-container"> <div class="elementor-icon-wrapper"> <div class="elementor-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-sync-alt" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M370.72 133.28C339.458 104.008 298.888 87.962 255.848 88c-77.458.068-144.328 53.178-162.791 126.85-1.344 5.363-6.122 9.15-11.651 9.15H24.103c-7.498 0-13.194-6.807-11.807-14.176C33.933 94.924 134.813 8 256 8c66.448 0 126.791 26.136 171.315 68.685L463.03 40.97C478.149 25.851 504 36.559 504 57.941V192c0 13.255-10.745 24-24 24H345.941c-21.382 0-32.09-25.851-16.971-40.971l41.75-41.749zM32 296h134.059c21.382 0 32.09 25.851 16.971 40.971l-41.75 41.75c31.262 29.273 71.835 45.319 114.876 45.28 77.418-.07 144.315-53.144 162.787-126.849 1.344-5.363 6.122-9.15 11.651-9.15h57.304c7.498 0 13.194 6.807 11.807 14.176C478.067 417.076 377.187 504 256 504c-66.448 0-126.791-26.136-171.315-68.685L48.97 471.03C33.851 486.149 8 475.441 8 454.059V320c0-13.255 10.745-24 24-24z"></path></svg> </div> </div> </div> </div> <div class="elementor-element elementor-element-20f2c6c elementor-widget elementor-widget-heading" data-id="20f2c6c" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h3 class="elementor-heading-title elementor-size-default">Regulatory Authorities Interaction</h3> </div> </div> <div class="elementor-element elementor-element-cfaee85 elementor-widget elementor-widget-text-editor" data-id="cfaee85" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p>Engaging with competent regulatory authorities to obtain necessary approvals and maintain transparent communication regarding regulatory aspects of the kit.</p> </div> </div> </div> </div> </div> <div class="elementor-element elementor-element-f5d8455 e-flex e-con-boxed e-con e-parent" data-id="f5d8455" data-element_type="container" data-settings="{"background_background":"classic"}"> <div class="e-con-inner"> <div class="elementor-element elementor-element-5327574 e-flex e-con-boxed e-con e-child" data-id="5327574" data-element_type="container"> <div class="e-con-inner"> <div class="elementor-element elementor-element-c14d266 elementor-widget 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