CINXE.COM
Regulatory Consulting for Program and Trial Design
<!doctype html><html lang="en"><head> <meta charset="utf-8"> <title>Regulatory Consulting for Program and Trial Design</title> <link rel="shortcut icon" href="https://www.veristat.com/hubfs/favicon.ico"> <meta name="description" content="Veristat offers regulatory consulting expertise - strategic regulatory planning, cross-functional operational support and the knowledge of how to present your regulatory strategy, non-clinical toxicology plans, clinical trial design, and product development goals to the regulatory agencies."> <meta name="viewport" content="width=device-width, initial-scale=1"> <script src="/hs/hsstatic/jquery-libs/static-1.1/jquery/jquery-1.7.1.js"></script> <script>hsjQuery = window['jQuery'];</script> <meta property="og:description" content="Veristat offers regulatory consulting expertise - strategic regulatory planning, cross-functional operational support and the knowledge of how to present your regulatory strategy, non-clinical toxicology plans, clinical trial design, and product development goals to the regulatory agencies."> <meta property="og:title" content="Regulatory Consulting for Program and Trial Design"> <meta name="twitter:description" content="Veristat offers regulatory consulting expertise - strategic regulatory planning, cross-functional operational support and the knowledge of how to present your regulatory strategy, non-clinical toxicology plans, clinical trial design, and product development goals to the regulatory agencies."> <meta name="twitter:title" content="Regulatory Consulting for Program and Trial Design"> <style> a.cta_button{-moz-box-sizing:content-box !important;-webkit-box-sizing:content-box !important;box-sizing:content-box !important;vertical-align:middle}.hs-breadcrumb-menu{list-style-type:none;margin:0px 0px 0px 0px;padding:0px 0px 0px 0px}.hs-breadcrumb-menu-item{float:left;padding:10px 0px 10px 10px}.hs-breadcrumb-menu-divider:before{content:'›';padding-left:10px}.hs-featured-image-link{border:0}.hs-featured-image{float:right;margin:0 0 20px 20px;max-width:50%}@media (max-width: 568px){.hs-featured-image{float:none;margin:0;width:100%;max-width:100%}}.hs-screen-reader-text{clip:rect(1px, 1px, 1px, 1px);height:1px;overflow:hidden;position:absolute !important;width:1px} </style> <link rel="stylesheet" href="https://www.veristat.com/hs-fs/hub/1333476/hub_generated/template_assets/63712159645/1726675697504/VERISTAT-CLEAN-2022/css/main-head.css"> <link rel="stylesheet" href="https://www.veristat.com/hs-fs/hub/1333476/hub_generated/template_assets/63712050360/1732158771693/VERISTAT-CLEAN-2022/css/main-foot.min.css"> <link rel="stylesheet" href="https://www.veristat.com/hs-fs/hub/1333476/hub_generated/template_assets/63711874203/1726675694524/VERISTAT-CLEAN-2022/css/modules/global-header-v2.min.css"> <style> /******************************* MAIN DESKTOP NAV STYLE *******************************/ .hhs-top-bar { background-color: rgba(249, 249, 249, 1); 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} .hhs-top-bar.sticky-menu .hs-menu-wrapper.hs-menu-flow-horizontal>ul li a:hover, .hhs-top-bar.hhs-alt-nav .hs-menu-wrapper.hs-menu-flow-horizontal>ul li a:hover, .hhs-top-bar.hhs-alt-nav .hhs-top-bar .hs-menu-wrapper.hs-menu-flow-horizontal .hs-menu-depth-1:first-child:hover, .hhs-top-bar.hhs-alt-nav .hhs-header-search a i:hover, .hhs-top-bar.hhs-alt-nav .fas:hover, .hhs-top-bar.hhs-alt-nav .hhs-lang-switch .globe_class:before, .sticky-menu .hhs-top-bar .hs-menu-wrapper.hs-menu-flow-horizontal .hs-menu-depth-1:first-child:hover, .sticky-menu .hs-menu-wrapper.hs-menu-flow-horizontal ul.hhs-nav-links li a:hover, .sticky-menu .hhs-header-search a i:hover{ color: rgba(0, 0, 0, 1.0); } .hhs-top-bar.hhs-alt-nav .hhs-header-search a i, .hhs-top-bar.hhs-alt-nav .globe_class { color: rgba(68, 68, 68, 1) !important; } .hhs-top-bar.hhs-alt-nav .hhs-top-bar .hs-menu-wrapper.hs-menu-flow-horizontal>ul li a:hover, .hhs-top-bar.hhs-alt-nav .hhs-header-search a i:hover, .hhs-top-bar.hhs-alt-nav .globe_class:hover { color: rgba(0, 0, 0, 1) !important; } .hhs-top-bar.hhs-alt-nav .hs-menu-wrapper.hs-menu-flow-horizontal>ul li.hs-menu-depth-1.active:after, .hhs-top-bar.hhs-alt-nav .hs-menu-wrapper.hs-menu-flow-horizontal>ul li.hs-menu-depth-1:after, .sticky-menu.hhs-top-bar .hs-menu-wrapper.hs-menu-flow-horizontal>ul li.hs-menu-depth-1.active:after, .sticky-menu.hhs-top-bar .hs-menu-wrapper.hs-menu-flow-horizontal>ul li.hs-menu-depth-1:after { background-color: rgba(0, 164, 189, 1.0); } /* CTA */ .hhs-header-cta .cta-secondary, .hhs-header-cta .cta-tertiary, .hhs-header-cta .cta-primary { padding: 15px 15px !important; font-size: 10px !important; -webkit-box-shadow: none; box-shadow: none; } /******************************* END *******************************/ /******************************* SIDE MENU *******************************/ .hhs-side-menu { width: 320px; } .hhs-side-menu { background-color: rgba(255, 255, 255, 1.0); } .body-wrapper::after { background-color: rgba(0, 0, 0, 0.3); } /* ICON */ .hamburger-icon .line { background: rgba(0, 102, 51, 1.0); } .hhs-top-bar.hhs-alt-nav .hamburger-icon .line, .sticky-menu .hamburger-icon .line { background: rgba(68, 68, 68, 1.0); } .hamburger-icon.active .line { background: rgba(68, 68, 68, 1.0); } .hhs-side-menu__controls .hhs-lang-switch { right: 70px !important; } /* LANG GLOBE & SEARCH */ .hhs-side-menu .hhs-lang-switch .globe_class:before, .hhs-side-menu .fas{ color: rgba(68, 68, 68, 1.0); } .hhs-top-bar .fas { color: #4A4A4A; } .hhs-side-menu__footer a i, .hhs-side-menu__footer a:visited i { color: #333333; } .hhs-side-menu__footer a:hover i, .hhs-side-menu__footer a:focus i { color: #666666; } /** MAIN MENU **/ .hhs-side-menu .hhs-side-menu__mobile li a { font-size: 18px; font-weight: nomral; color: rgba(102, 102, 102, 1.0); } .hhs-side-menu .hhs-side-menu__mobile li a:hover { color: rgba(0, 0, 0, 1.0); } .hhs-sidebar-nav-toggle i { color: rgba(153, 153, 153, 1.0); } /** EXTRAS MENU **/ .hhs-side-menu__extras .hs-menu-item a, .hhs-side-menu__extras .hs-menu-wrapper.hs-menu-flow-horizontal>ul li.hs-item-has-children ul.hs-menu-children-wrapper a { font-size: 14px; font-weight: nomral; color: rgba(74, 74, 74, 1); } .hhs-side-menu__extras .hs-menu-item a:hover, .hhs-side-menu__extras .hs-menu-wrapper.hs-menu-flow-horizontal>ul li.hs-item-has-children ul.hs-menu-children-wrapper a:hover { color: rgba(0, 164, 189, 1); } /* FOR LAST BLOCK IN SIDE MENU */ .hhs-side-menu__extras {flex: 1;} @media (max-width: 575px) { .hhs-side-menu { width: 100%; } } /******************************* END *******************************/ /******************************* MEGA MENU *******************************/ /******************************* END *******************************/ /******************************* RESPONSIVE SIDE MENU *******************************/ .hhs-menu-toggle { display: none; } @media (max-width: 960px) { .hhs-menu-toggle { display: block; } } @media (max-width: 920px) { .hhs-menu-toggle { display: block; } } /* CTAS */ .hhs-side-menu__ctas .hhs-side-cta-1, .hhs-side-menu__ctas .hhs-side-cta-2{ display: none; } @media (max-width: 960px) { .hhs-extras-ctas, .hhs-extras-ctas .hhs-head-cta-1 { display: none; } .hhs-side-menu__ctas .hhs-side-cta-1 { display: inline-block; } } @media (max-width: 920px) { .hhs-extras-ctas .hhs-head-cta-2 { display: none; } .hhs-side-menu__ctas .hhs-side-cta-2 { display: inline-block; } } /* MAIN NAV */ @media (min-width: 768px) { .hhs-side-menu__mobile { display: none; } } @media (max-width: 768px) { .main-nav .sc-site-header__menu { display: none; } } /* FORM */ /******************************* END *******************************/ /******************************* HEADER HAT *******************************/ .hhs-header-hat { background-color: rgba(0, 102, 51, 1.0); padding: 5px 0; } .hhs-hat-menu .hs-menu-wrapper.hs-menu-flow-horizontal>ul li.hs-menu-depth-1 a { color: rgba(255, 255, 255, 1.0); font-size: 12px; font-weight: normal; } .hhs-hat-menu .hs-menu-wrapper.hs-menu-flow-horizontal>ul li.hs-menu-depth-1 a:hover { color: rgba(238, 238, 238, 1.0); } @media (max-width: 575px) { .hhs-header-hat { display: none; } } /******************************* END *******************************/ /** TABLET CSS **/ @media (max-width: 768px) { .custom-menu-primary .hs-menu-wrapper > ul { margin-top: 10px !important; } .custom-menu-primary .hs-menu-wrapper > ul, .custom-menu-primary .hs-menu-wrapper > ul li.active a:hover{ background-color: rgba(0, 102, 51, 1) !important; } .hhs-top-bar .hs-menu-wrapper.hs-menu-flow-horizontal>ul li a:hover, .custom-menu-primary .hs-menu-wrapper > ul li.active a:hover { color: #FFFFFF ; } .custom-menu-primary .hs-menu-wrapper > ul li{ border-top: 1px solid rgba(255, 255, 255, .2) !important; } .custom-menu-primary .hs-menu-wrapper > ul ul li{ background-color: rgba(255, 255, 255, .15); } .sticky-menu.active { position: static !important; } .sticky-menu.active { display: none !important; height: 0px !important; } } /** MOBILE CSS **/ @media (max-width: 575px) { .logo-standard, .logo-sticky { max-width: 140px !important; } .hhs-nav-opt-items .hhs-header-search { right: 3px; } .hhs-nav-opt-items .hhs-lang-switch { right: 33px; } } </style> <link rel="stylesheet" href="https://www.veristat.com/hs-fs/hub/1333476/hub_generated/template_assets/63706222910/1726675698575/VERISTAT-CLEAN-2022/css/modules/global-footer.min.css"> <style> /******************************* MAIN DESKTOP NAV STYLE *******************************/ #hs_cos_wrapper_global_footer .hhs-footer-mod { padding-top: 50px; padding-bottom: 25px; background-color: rgba(244, 244, 244, 1.0); } /** NAVIGATION COLUMNS STYLE **/ .hhs-foot-base-nav .hs-menu-wrapper.hs-menu-flow-horizontal > ul li a, .hhs-foot-nav-col .hs-menu-wrapper.hs-menu-flow-horizontal>ul li.hs-item-has-children ul.hs-menu-children-wrapper li a, .hhs-foot-nav-col .hs-menu-wrapper.hs-menu-flow-horizontal > ul li a { color: #888888 !important; } .hhs-foot-base-nav .hs-menu-wrapper.hs-menu-flow-horizontal > ul li a:hover, .hhs-foot-nav-col .hs-menu-wrapper.hs-menu-flow-horizontal>ul li.hs-item-has-children ul.hs-menu-children-wrapper li a:hover, .hhs-foot-nav-col .hs-menu-wrapper.hs-menu-flow-horizontal > ul li a:hover { color: #555555 !important; } .foot-nav-title, .hhs-foot-rss h5, .hhs-foot-nav-col h5 { margin-bottom: 28px; color: #006633; } .hhs-foot-rss .hs_cos_wrapper_type_inline_rich_text p, .hhs-foot-rss .hs_cos_wrapper_type_inline_rich_text l1, .hhs-foot-rss .hs_cos_wrapper_type_inline_rich_text span, .hhs-foot-rss label{ color: #4A4A4A; } .hhs-foot-base-nav .hs-menu-wrapper.hs-menu-flow-horizontal > ul li a { font-size: 13px; } /** BLOG POST STYLE **/ .hhs-footer-mod .hhs-post-content a h6 { color: #FFFFFF; font-size: 16px; line-height: 20px; } .hhs-footer-mod .hhs-post-summary p { color: #4A4A4A; font-size: 14px; line-height: 18px; } .hhs-foot-rss .hs-rss-title:hover { color: #00a4bd; } .hhs-footer-mod .hhs-post-feat-img { min-height: 120px; } .hhs-foot-rss .hs-rss-item.hs-with-featured-image .hs-rss-item-text { margin-top: 120px; } .hhs-foot-break-line { border-color: #006633; } .hhs-foot-copyright { color: #006633; } /** TOGGLE COLLAPSE **/ @media (max-width: 575px) { .hhs-foot-nav-col .hhs-col-content { display: none; text-align: center; } .hhs-foot-nav-col .hhs-col-content.open-menu { display: block; text-align: center; } } /** SOCIAL ICONS **/#hs_cos_wrapper_global_footer .hhs-social-con i { color: #006633;} #hs_cos_wrapper_global_footer .hhs-social-con i:hover {color: #9CCD4E;}/** TABLET CSS **/ @media (max-width: 768px) { #hs_cos_wrapper_global_footer .hhs-footer-mod { padding-top: 25px; padding-bottom: 25px; } } /** BACK TO TOP **/ #return-to-top { background: rgba(68, 68, 68, 0.7); } #return-to-top:hover { background: rgba(68, 68, 68, 0.9); } /** MOBILE CSS **/ @media (max-width: 575px) { #hs_cos_wrapper_global_footer .hhs-footer-mod { padding-top: 25px; padding-bottom: 25px; } .hhs-foot-nav-col { border-color: #006633; } } </style> <style> </style> <link rel="stylesheet" href="https://www.veristat.com/hs-fs/hub/1333476/hub_generated/module_assets/63712049542/1732009637377/module_63712049542_VERIS_-_Row_-_Multi-Column_Content.min.css"> <style> /******************************* ROW STYLE *******************************/ #hs_cos_wrapper_widget_1648791709185 .hhs-text-mod { padding-top: 50px; padding-bottom: 50px;background-color: rgba(#null, 0.0);} @media (max-width: 768px) { #hs_cos_wrapper_widget_1648791709185 .hhs-text-mod { padding-top: 50px; padding-bottom: 50px; } } @media (max-width: 575px) { #hs_cos_wrapper_widget_1648791709185 .hhs-text-mod { padding-top: 25px; padding-bottom: 25px; } } /* VIDEO BACKGROUND *//* PARALLAX */ /* HERO OVERLAY COLOR *//* OUTER/INNER SHADOW *//* PULL UP ROW *//* WAVE *//******************************* END *******************************/ /******************************* COLUMN 1 *******************************/ /* TEXT STYLES */ #hs_cos_wrapper_widget_1648791709185 .c1 .hhs-rich-text, #hs_cos_wrapper_widget_1648791709185 .c1 .hhs-rich-text h1, #hs_cos_wrapper_widget_1648791709185 .c1 .hhs-rich-text h2,#hs_cos_wrapper_widget_1648791709185 .c1 .hhs-rich-text h3, #hs_cos_wrapper_widget_1648791709185 .c1 .hhs-rich-text h4, #hs_cos_wrapper_widget_1648791709185 .c1 .hhs-rich-text h5, #hs_cos_wrapper_widget_1648791709185 .c1 .hhs-rich-text h6, #hs_cos_wrapper_widget_1648791709185 .c1 .hhs-rich-text p, #hs_cos_wrapper_widget_1648791709185 .c1 .hhs-rich-text span, #hs_cos_wrapper_widget_1648791709185 .c1 .hhs-rich-text li, #hs_cos_wrapper_widget_1648791709185 .c1 .hhs-rich-text blockquote {text-align: left; }@media (max-width: 992px) { #hs_cos_wrapper_widget_1648791709185 .c1 .hhs-rich-text h1, #hs_cos_wrapper_widget_1648791709185 .c1 .hhs-rich-text h2,#hs_cos_wrapper_widget_1648791709185 .c1 .hhs-rich-text h3, #hs_cos_wrapper_widget_1648791709185 .c1 .hhs-rich-text h4, #hs_cos_wrapper_widget_1648791709185 .c1 .hhs-rich-text h5, #hs_cos_wrapper_widget_1648791709185 .c1 .hhs-rich-text h6, #hs_cos_wrapper_widget_1648791709185 .c1 .hhs-rich-text p, #hs_cos_wrapper_widget_1648791709185 .c1 .hhs-rich-text span, #hs_cos_wrapper_widget_1648791709185 .c1 .hhs-rich-text li { text-align: left; } } @media (max-width: 575px) { #hs_cos_wrapper_widget_1648791709185 .c1 .hhs-rich-text h1, #hs_cos_wrapper_widget_1648791709185 .c1 .hhs-rich-text h2,#hs_cos_wrapper_widget_1648791709185 .c1 .hhs-rich-text h3, #hs_cos_wrapper_widget_1648791709185 .c1 .hhs-rich-text h4, #hs_cos_wrapper_widget_1648791709185 .c1 .hhs-rich-text h5, #hs_cos_wrapper_widget_1648791709185 .c1 .hhs-rich-text h6, #hs_cos_wrapper_widget_1648791709185 .c1 .hhs-rich-text p, #hs_cos_wrapper_widget_1648791709185 .c1 .hhs-rich-text span, #hs_cos_wrapper_widget_1648791709185 .c1 .hhs-rich-text li { text-align: left; } } /* BACKGROUND *//* SPACING *//* PULL UP CONTENT OPTION *//* FORM STYLE *//* DIVIDER *//* VERTICAL ALIGN *//* MODAL *//******************************* END *******************************/ /******************************* COLUMN 2 *******************************/ /******************************* END *******************************/ /******************************* COLUMN 3 *******************************/ /******************************* END *******************************/ /******************************* COLUMN 4 *******************************/ /******************************* END *******************************/ </style> <link class="hs-async-css" rel="preload" href="https://www.veristat.com/hs-fs/hub/1333476/hub_generated/template_assets/63711874859/1726675697348/VERISTAT-CLEAN-2022/css/modules/row-multi-column-content.min.css" as="style" onload="this.onload=null;this.rel='stylesheet'"> <noscript><link rel="stylesheet" href="https://www.veristat.com/hs-fs/hub/1333476/hub_generated/template_assets/63711874859/1726675697348/VERISTAT-CLEAN-2022/css/modules/row-multi-column-content.min.css"></noscript> <style> /******************************* ROW STYLE *******************************/ #hs_cos_wrapper_widget_1642359942501 .hhs-text-mod { padding-top: 25px; padding-bottom: 10px;background-color: rgba(255, 255, 255, 1);} @media (max-width: 768px) { #hs_cos_wrapper_widget_1642359942501 .hhs-text-mod { padding-top: 50px; padding-bottom: 50px; } } @media (max-width: 575px) { #hs_cos_wrapper_widget_1642359942501 .hhs-text-mod { padding-top: 25px; padding-bottom: 25px; } } /* VIDEO BACKGROUND *//* PARALLAX */ /* HERO OVERLAY COLOR *//* OUTER/INNER SHADOW *//* PULL UP ROW *//* WAVE *//******************************* END *******************************/ /******************************* COLUMN 1 *******************************/ /* TEXT STYLES */ #hs_cos_wrapper_widget_1642359942501 .c1 .hhs-rich-text, #hs_cos_wrapper_widget_1642359942501 .c1 .hhs-rich-text h1, #hs_cos_wrapper_widget_1642359942501 .c1 .hhs-rich-text h2,#hs_cos_wrapper_widget_1642359942501 .c1 .hhs-rich-text h3, #hs_cos_wrapper_widget_1642359942501 .c1 .hhs-rich-text h4, #hs_cos_wrapper_widget_1642359942501 .c1 .hhs-rich-text h5, #hs_cos_wrapper_widget_1642359942501 .c1 .hhs-rich-text h6, #hs_cos_wrapper_widget_1642359942501 .c1 .hhs-rich-text p, #hs_cos_wrapper_widget_1642359942501 .c1 .hhs-rich-text span, #hs_cos_wrapper_widget_1642359942501 .c1 .hhs-rich-text li, #hs_cos_wrapper_widget_1642359942501 .c1 .hhs-rich-text blockquote {text-align: left; }@media (max-width: 992px) { #hs_cos_wrapper_widget_1642359942501 .c1 .hhs-rich-text h1, #hs_cos_wrapper_widget_1642359942501 .c1 .hhs-rich-text h2,#hs_cos_wrapper_widget_1642359942501 .c1 .hhs-rich-text h3, #hs_cos_wrapper_widget_1642359942501 .c1 .hhs-rich-text h4, #hs_cos_wrapper_widget_1642359942501 .c1 .hhs-rich-text h5, #hs_cos_wrapper_widget_1642359942501 .c1 .hhs-rich-text h6, #hs_cos_wrapper_widget_1642359942501 .c1 .hhs-rich-text p, #hs_cos_wrapper_widget_1642359942501 .c1 .hhs-rich-text span, #hs_cos_wrapper_widget_1642359942501 .c1 .hhs-rich-text li { text-align: left; } } @media (max-width: 575px) { #hs_cos_wrapper_widget_1642359942501 .c1 .hhs-rich-text h1, #hs_cos_wrapper_widget_1642359942501 .c1 .hhs-rich-text h2,#hs_cos_wrapper_widget_1642359942501 .c1 .hhs-rich-text h3, #hs_cos_wrapper_widget_1642359942501 .c1 .hhs-rich-text h4, #hs_cos_wrapper_widget_1642359942501 .c1 .hhs-rich-text h5, #hs_cos_wrapper_widget_1642359942501 .c1 .hhs-rich-text h6, #hs_cos_wrapper_widget_1642359942501 .c1 .hhs-rich-text p, #hs_cos_wrapper_widget_1642359942501 .c1 .hhs-rich-text span, #hs_cos_wrapper_widget_1642359942501 .c1 .hhs-rich-text li { text-align: left; } } /* BACKGROUND *//* SPACING *//* PULL UP CONTENT OPTION *//* FORM STYLE *//* DIVIDER *//* VERTICAL ALIGN *//* MODAL *//******************************* END *******************************/ /******************************* COLUMN 2 *******************************/ /******************************* END *******************************/ /******************************* COLUMN 3 *******************************/ /******************************* END *******************************/ /******************************* COLUMN 4 *******************************/ /******************************* END *******************************/ </style> <style> /******************************* ROW STYLE *******************************/ #hs_cos_wrapper_widget_1642360381667 .hhs-text-mod { padding-top: 10px; padding-bottom: 10px;background-color: rgba(#null, 0.0);} @media (max-width: 768px) { #hs_cos_wrapper_widget_1642360381667 .hhs-text-mod { padding-top: 50px; padding-bottom: 50px; } } @media (max-width: 575px) { #hs_cos_wrapper_widget_1642360381667 .hhs-text-mod { padding-top: 25px; padding-bottom: 25px; } } /* VIDEO BACKGROUND *//* PARALLAX */ /* HERO OVERLAY COLOR *//* OUTER/INNER SHADOW *//* PULL UP ROW *//* WAVE *//******************************* END *******************************/ /******************************* COLUMN 1 *******************************/ /* TEXT STYLES */ #hs_cos_wrapper_widget_1642360381667 .c1 .hhs-rich-text, #hs_cos_wrapper_widget_1642360381667 .c1 .hhs-rich-text h1, #hs_cos_wrapper_widget_1642360381667 .c1 .hhs-rich-text h2,#hs_cos_wrapper_widget_1642360381667 .c1 .hhs-rich-text h3, #hs_cos_wrapper_widget_1642360381667 .c1 .hhs-rich-text h4, #hs_cos_wrapper_widget_1642360381667 .c1 .hhs-rich-text h5, #hs_cos_wrapper_widget_1642360381667 .c1 .hhs-rich-text h6, #hs_cos_wrapper_widget_1642360381667 .c1 .hhs-rich-text p, #hs_cos_wrapper_widget_1642360381667 .c1 .hhs-rich-text span, #hs_cos_wrapper_widget_1642360381667 .c1 .hhs-rich-text li, #hs_cos_wrapper_widget_1642360381667 .c1 .hhs-rich-text blockquote {text-align: left; }@media (max-width: 992px) { #hs_cos_wrapper_widget_1642360381667 .c1 .hhs-rich-text h1, #hs_cos_wrapper_widget_1642360381667 .c1 .hhs-rich-text h2,#hs_cos_wrapper_widget_1642360381667 .c1 .hhs-rich-text h3, #hs_cos_wrapper_widget_1642360381667 .c1 .hhs-rich-text h4, #hs_cos_wrapper_widget_1642360381667 .c1 .hhs-rich-text h5, #hs_cos_wrapper_widget_1642360381667 .c1 .hhs-rich-text h6, #hs_cos_wrapper_widget_1642360381667 .c1 .hhs-rich-text p, #hs_cos_wrapper_widget_1642360381667 .c1 .hhs-rich-text span, #hs_cos_wrapper_widget_1642360381667 .c1 .hhs-rich-text li { text-align: left; } } @media (max-width: 575px) { #hs_cos_wrapper_widget_1642360381667 .c1 .hhs-rich-text h1, #hs_cos_wrapper_widget_1642360381667 .c1 .hhs-rich-text h2,#hs_cos_wrapper_widget_1642360381667 .c1 .hhs-rich-text h3, #hs_cos_wrapper_widget_1642360381667 .c1 .hhs-rich-text h4, #hs_cos_wrapper_widget_1642360381667 .c1 .hhs-rich-text h5, #hs_cos_wrapper_widget_1642360381667 .c1 .hhs-rich-text h6, #hs_cos_wrapper_widget_1642360381667 .c1 .hhs-rich-text p, #hs_cos_wrapper_widget_1642360381667 .c1 .hhs-rich-text span, #hs_cos_wrapper_widget_1642360381667 .c1 .hhs-rich-text li { text-align: left; } } /* BACKGROUND *//* SPACING *//* PULL UP CONTENT OPTION *//* FORM STYLE *//* DIVIDER *//* VERTICAL ALIGN *//* MODAL *//******************************* END *******************************/ /******************************* COLUMN 2 *******************************/ /******************************* END *******************************/ /******************************* COLUMN 3 *******************************/ /******************************* END *******************************/ /******************************* COLUMN 4 *******************************/ /******************************* END *******************************/ </style> <style> /******************************* ROW STYLE *******************************/ #hs_cos_wrapper_widget_1643664750927 .hhs-text-mod { padding-top: 10px; padding-bottom: 50px;background-color: rgba(255, 255, 255, 1);} @media (max-width: 768px) { #hs_cos_wrapper_widget_1643664750927 .hhs-text-mod { padding-top: 50px; padding-bottom: 50px; } } @media (max-width: 575px) { #hs_cos_wrapper_widget_1643664750927 .hhs-text-mod { padding-top: 25px; padding-bottom: 25px; } } /* VIDEO BACKGROUND *//* PARALLAX */ /* HERO OVERLAY COLOR *//* OUTER/INNER SHADOW *//* PULL UP ROW *//* WAVE *//******************************* END *******************************/ /******************************* COLUMN 1 *******************************/ /* TEXT STYLES */ #hs_cos_wrapper_widget_1643664750927 .c1 .hhs-rich-text, #hs_cos_wrapper_widget_1643664750927 .c1 .hhs-rich-text h1, #hs_cos_wrapper_widget_1643664750927 .c1 .hhs-rich-text h2,#hs_cos_wrapper_widget_1643664750927 .c1 .hhs-rich-text h3, #hs_cos_wrapper_widget_1643664750927 .c1 .hhs-rich-text h4, #hs_cos_wrapper_widget_1643664750927 .c1 .hhs-rich-text h5, #hs_cos_wrapper_widget_1643664750927 .c1 .hhs-rich-text h6, #hs_cos_wrapper_widget_1643664750927 .c1 .hhs-rich-text p, #hs_cos_wrapper_widget_1643664750927 .c1 .hhs-rich-text span, #hs_cos_wrapper_widget_1643664750927 .c1 .hhs-rich-text li, #hs_cos_wrapper_widget_1643664750927 .c1 .hhs-rich-text blockquote {text-align: left; }@media (max-width: 992px) { #hs_cos_wrapper_widget_1643664750927 .c1 .hhs-rich-text h1, #hs_cos_wrapper_widget_1643664750927 .c1 .hhs-rich-text h2,#hs_cos_wrapper_widget_1643664750927 .c1 .hhs-rich-text h3, #hs_cos_wrapper_widget_1643664750927 .c1 .hhs-rich-text h4, #hs_cos_wrapper_widget_1643664750927 .c1 .hhs-rich-text h5, #hs_cos_wrapper_widget_1643664750927 .c1 .hhs-rich-text h6, #hs_cos_wrapper_widget_1643664750927 .c1 .hhs-rich-text p, #hs_cos_wrapper_widget_1643664750927 .c1 .hhs-rich-text span, #hs_cos_wrapper_widget_1643664750927 .c1 .hhs-rich-text li { text-align: left; } } @media (max-width: 575px) { #hs_cos_wrapper_widget_1643664750927 .c1 .hhs-rich-text h1, #hs_cos_wrapper_widget_1643664750927 .c1 .hhs-rich-text h2,#hs_cos_wrapper_widget_1643664750927 .c1 .hhs-rich-text h3, #hs_cos_wrapper_widget_1643664750927 .c1 .hhs-rich-text h4, #hs_cos_wrapper_widget_1643664750927 .c1 .hhs-rich-text h5, #hs_cos_wrapper_widget_1643664750927 .c1 .hhs-rich-text h6, #hs_cos_wrapper_widget_1643664750927 .c1 .hhs-rich-text p, #hs_cos_wrapper_widget_1643664750927 .c1 .hhs-rich-text span, #hs_cos_wrapper_widget_1643664750927 .c1 .hhs-rich-text li { text-align: left; } } /* BACKGROUND *//* SPACING *//* PULL UP CONTENT OPTION *//* FORM STYLE *//* DIVIDER *//* VERTICAL ALIGN *//* MODAL *//******************************* END *******************************/ /******************************* COLUMN 2 *******************************/ /******************************* END *******************************/ /******************************* COLUMN 3 *******************************/ /******************************* END *******************************/ /******************************* COLUMN 4 *******************************/ /******************************* END *******************************/ </style> <style> /******************************* ROW STYLE *******************************/ #hs_cos_wrapper_widget_1647525501169 .hhs-testimonial-card-mod { padding-top: 50px; padding-bottom: 50px; background-color: rgba(255, 255, 255, 1); } @media (max-width: 768px) { #hs_cos_wrapper_widget_1647525501169 .hhs-testimonial-card-mod { padding-top: 50px; padding-bottom: 50px; } } @media (max-width: 575px) { #hs_cos_wrapper_widget_1647525501169 .hhs-testimonial-card-mod { padding-top: 25px; padding-bottom: 25px; } } /* SHADOW */ /* PARALLAX */ /* OVERLAY */ /* PULL UP */ /* WAVE *//******************************* END *******************************/ /******************************* CARD STYLE *******************************/ #hs_cos_wrapper_widget_1647525501169 .hhs-testimonial-card { background: rgba(255, 255, 255, 1); padding: 25px; -webkit-box-shadow: 0 0 15px 0 rgba(0,0,0,0.1); box-shadow: 0 0 15px 0 rgba(0,0,0,0.1); } #hs_cos_wrapper_widget_1647525501169 .hhs-testimonial-content { padding: 0px; text-align: center; } #hs_cos_wrapper_widget_1647525501169 .hhs-testimonial-card blockquote {font-size: 24px;} #hs_cos_wrapper_widget_1647525501169 .hhs-testimonial-card img { -webkit-border-radius: 100%; border-radius: 100%; text-align: center; display: block; margin: 0 auto 25px; } /* STAR RATING */ #hs_cos_wrapper_widget_1647525501169 .star-rating .star-solid { color: #f1a604; } #hs_cos_wrapper_widget_1647525501169 .star-rating .star-outline { color: #ccc; } </style> <link class="hs-async-css" rel="preload" href="https://www.veristat.com/hs-fs/hub/1333476/hub_generated/template_assets/63705167760/1726675699372/VERISTAT-CLEAN-2022/css/modules/row-testimonial-cards.min.css" as="style" onload="this.onload=null;this.rel='stylesheet'"> <noscript><link rel="stylesheet" href="https://www.veristat.com/hs-fs/hub/1333476/hub_generated/template_assets/63705167760/1726675699372/VERISTAT-CLEAN-2022/css/modules/row-testimonial-cards.min.css"></noscript> <style> /******************************* ROW STYLE *******************************/ #hs_cos_wrapper_widget_1642360696334 .hhs-text-mod { padding-top: 50px; padding-bottom: 50px;background-color: rgba(255, 255, 255, 1);} @media (max-width: 768px) { #hs_cos_wrapper_widget_1642360696334 .hhs-text-mod { padding-top: 50px; padding-bottom: 50px; } } @media (max-width: 575px) { #hs_cos_wrapper_widget_1642360696334 .hhs-text-mod { padding-top: 25px; padding-bottom: 25px; } } /* VIDEO BACKGROUND *//* PARALLAX */ /* HERO OVERLAY COLOR *//* OUTER/INNER SHADOW *//* PULL UP ROW *//* WAVE *//******************************* END *******************************/ /******************************* COLUMN 1 *******************************/ /* TEXT STYLES */ #hs_cos_wrapper_widget_1642360696334 .c1 .hhs-rich-text, #hs_cos_wrapper_widget_1642360696334 .c1 .hhs-rich-text h1, #hs_cos_wrapper_widget_1642360696334 .c1 .hhs-rich-text h2,#hs_cos_wrapper_widget_1642360696334 .c1 .hhs-rich-text h3, #hs_cos_wrapper_widget_1642360696334 .c1 .hhs-rich-text h4, #hs_cos_wrapper_widget_1642360696334 .c1 .hhs-rich-text h5, #hs_cos_wrapper_widget_1642360696334 .c1 .hhs-rich-text h6, #hs_cos_wrapper_widget_1642360696334 .c1 .hhs-rich-text p, #hs_cos_wrapper_widget_1642360696334 .c1 .hhs-rich-text span, #hs_cos_wrapper_widget_1642360696334 .c1 .hhs-rich-text li, #hs_cos_wrapper_widget_1642360696334 .c1 .hhs-rich-text blockquote {text-align: left; }@media (max-width: 992px) { #hs_cos_wrapper_widget_1642360696334 .c1 .hhs-rich-text h1, #hs_cos_wrapper_widget_1642360696334 .c1 .hhs-rich-text h2,#hs_cos_wrapper_widget_1642360696334 .c1 .hhs-rich-text h3, #hs_cos_wrapper_widget_1642360696334 .c1 .hhs-rich-text h4, #hs_cos_wrapper_widget_1642360696334 .c1 .hhs-rich-text h5, #hs_cos_wrapper_widget_1642360696334 .c1 .hhs-rich-text h6, #hs_cos_wrapper_widget_1642360696334 .c1 .hhs-rich-text p, #hs_cos_wrapper_widget_1642360696334 .c1 .hhs-rich-text span, #hs_cos_wrapper_widget_1642360696334 .c1 .hhs-rich-text li { text-align: left; } } @media (max-width: 575px) { #hs_cos_wrapper_widget_1642360696334 .c1 .hhs-rich-text h1, #hs_cos_wrapper_widget_1642360696334 .c1 .hhs-rich-text h2,#hs_cos_wrapper_widget_1642360696334 .c1 .hhs-rich-text h3, #hs_cos_wrapper_widget_1642360696334 .c1 .hhs-rich-text h4, #hs_cos_wrapper_widget_1642360696334 .c1 .hhs-rich-text h5, #hs_cos_wrapper_widget_1642360696334 .c1 .hhs-rich-text h6, #hs_cos_wrapper_widget_1642360696334 .c1 .hhs-rich-text p, #hs_cos_wrapper_widget_1642360696334 .c1 .hhs-rich-text span, #hs_cos_wrapper_widget_1642360696334 .c1 .hhs-rich-text li { text-align: left; } } /* BACKGROUND *//* SPACING *//* PULL UP CONTENT OPTION *//* FORM STYLE *//* DIVIDER *//* VERTICAL ALIGN *//* MODAL *//******************************* END *******************************/ /******************************* COLUMN 2 *******************************/ /* TEXT STYLES */ #hs_cos_wrapper_widget_1642360696334 .c2 .hhs-rich-text,#hs_cos_wrapper_widget_1642360696334 .c2 .hhs-rich-text h1, #hs_cos_wrapper_widget_1642360696334 .c2 .hhs-rich-text h2,#hs_cos_wrapper_widget_1642360696334 .c2 .hhs-rich-text h3, #hs_cos_wrapper_widget_1642360696334 .c2 .hhs-rich-text h4, #hs_cos_wrapper_widget_1642360696334 .c2 .hhs-rich-text h5, #hs_cos_wrapper_widget_1642360696334 .c2 .hhs-rich-text h6, #hs_cos_wrapper_widget_1642360696334 .c2 .hhs-rich-text p, #hs_cos_wrapper_widget_1642360696334 .c2 .hhs-rich-text span, #hs_cos_wrapper_widget_1642360696334 .c2 .hhs-rich-text li, #hs_cos_wrapper_widget_1642360696334 .c2 .hhs-rich-text blockquote {text-align: left; }@media (max-width: 992px) { #hs_cos_wrapper_widget_1642360696334 .c2 .hhs-rich-text h1, #hs_cos_wrapper_widget_1642360696334 .c2 .hhs-rich-text h2,#hs_cos_wrapper_widget_1642360696334 .c2 .hhs-rich-text h3, #hs_cos_wrapper_widget_1642360696334 .c2 .hhs-rich-text h4, #hs_cos_wrapper_widget_1642360696334 .c2 .hhs-rich-text h5, #hs_cos_wrapper_widget_1642360696334 .c2 .hhs-rich-text h6, #hs_cos_wrapper_widget_1642360696334 .c2 .hhs-rich-text p, #hs_cos_wrapper_widget_1642360696334 .c2 .hhs-rich-text span, #hs_cos_wrapper_widget_1642360696334 .c2 .hhs-rich-text li { text-align: left; } } @media (max-width: 575px) { #hs_cos_wrapper_widget_1642360696334 .c2 .hhs-rich-text h1, #hs_cos_wrapper_widget_1642360696334 .c2 .hhs-rich-text h2,#hs_cos_wrapper_widget_1642360696334 .c2 .hhs-rich-text h3, #hs_cos_wrapper_widget_1642360696334 .c2 .hhs-rich-text h4, #hs_cos_wrapper_widget_1642360696334 .c2 .hhs-rich-text h5, #hs_cos_wrapper_widget_1642360696334 .c2 .hhs-rich-text h6, #hs_cos_wrapper_widget_1642360696334 .c2 .hhs-rich-text p, #hs_cos_wrapper_widget_1642360696334 .c2 .hhs-rich-text span, #hs_cos_wrapper_widget_1642360696334 .c2 .hhs-rich-text li { text-align: left; 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style="display:none">endocrine-metabolic-disease</span> <span style="display:none">therapeutic-expertise/immunology-and-inflammation</span> <span style="display:none">therapeutic-expertise/infectious-disease</span> <span style="display:none">therapeutic-expertise/covid-19</span> <span style="display:none">therapeutic-expertise/cardiology</span> <span style="display:none">therapeutic-expertise/other</span> <span style="display:none">solutions</span> <span style="display:none">full-service-cro-biologics</span> <span style="display:none">cro-cell-gene</span> <span style="display:none">therapeutic-expertise/vaccines</span> <span style="display:none">therapeutic-expertise/rare-diseases</span> <span style="display:none">therapeutic-expertise/pediatric-clinical-trials</span> <span style="display:none">decentralizedclinicaltrials</span> <span style="display:none">clinical-trial-rescue-programs</span> <span style="display:none">services/full-service-solutions</span> <span style="display:none">clinical-trial-planning</span> <span style="display:none">clinical-trial-conduct</span> <span style="display:none">regulatory-submission</span> <span style="display:none">solutions/natural-history-studies</span> <span style="display:none">services</span> <span style="display:none">services/strategic-consulting</span> <span style="display:none">adaptive-designs</span> <span style="display:none">services/introduction-statistical-power</span> <span style="display:none">services/regulatory-affairs-overview</span> <span style="display:none">services/regulatory-affairs/regulatory-consulting-for-program-and-trial-design</span> <span style="display:none">services/regulatory-affairs/regulatory-approvals</span> <span style="display:none">services/chemistry-manufacturing-controls-cmc</span> <span style="display:none">services/regulatory-affairs/regulatory-agency-meeting-support</span> <span style="display:none">services/regulatory-affairs/regulatory-publishing</span> <span 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style="display:none">services/biometrics/biostatistics</span> <span style="display:none">services/medical-affairs/data-monitoring-committees</span> <span style="display:none">services/biometrics/statistical-programming</span> <span style="display:none">services/biometrics/standards-implementation</span> <span style="display:none">pharmacovigilance</span> <span style="display:none">services/strategic-resourcing</span> <span style="display:none"></span> <span style="display:none">library</span> <span style="display:none">blog</span> <span style="display:none"></span> <span style="display:none"></span> <span style="display:none"></span> <span style="display:none">latest-newsletter</span> <span style="display:none">contact-us</span> <span style="display:none">rfp</span> <!-- loop in main nav and get lastest item menu label --> <span style="display:none"> regulatory-consulting-for-program-and-trial-design </span> Regulatory Consulting <!-- if lastest item menu label empty => get default one in url--> </div> </div> </div> </div> </div> <!-- End breadcrumb--><div class="custom " style=" max-width: 1140px; margin: auto;"> <div class="row"> <div data-wow-delay="none" class="wow none col-sm-12 c1 "> <div class="col-inner"> <div class="hhs-rich-text-in"> <div class="hhs-rich-text"> <h4>Regulatory Expertise Throughout the Entire Product Development Lifecycle</h4> <p><img src="https://www.veristat.com/hs-fs/hubfs/RegulatoryLifecycleChart_DarkGreenwithFade%20Background_Aug2021_ForPPT_USETHISONE-1.png?width=2911&name=RegulatoryLifecycleChart_DarkGreenwithFade%20Background_Aug2021_ForPPT_USETHISONE-1.png" alt="RegulatoryLifecycleChart_DarkGreenwithFade Background_Aug2021_ForPPT_USETHISONE-1" width="2911" loading="lazy" style="width: 2911px;" srcset="https://www.veristat.com/hs-fs/hubfs/RegulatoryLifecycleChart_DarkGreenwithFade%20Background_Aug2021_ForPPT_USETHISONE-1.png?width=1456&name=RegulatoryLifecycleChart_DarkGreenwithFade%20Background_Aug2021_ForPPT_USETHISONE-1.png 1456w, 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<span style="display:none">global-reach-locations</span> <span style="display:none">careers</span> <span style="display:none">careers/open-positions</span> <span style="display:none">veristat-culture-our-core-values</span> <span style="display:none">careers/explore-benefits</span> <span style="display:none">careers/life-at-veristat</span> <span style="display:none">because-we-care</span> <span style="display:none">why-veristat</span> <span style="display:none">therapeutic-expertise</span> <span style="display:none">therapeutic-expertise/oncology</span> <span style="display:none">therapeutic-expertise/neurology</span> <span style="display:none">endocrine-metabolic-disease</span> <span style="display:none">therapeutic-expertise/immunology-and-inflammation</span> <span style="display:none">therapeutic-expertise/infectious-disease</span> <span style="display:none">therapeutic-expertise/covid-19</span> <span style="display:none">therapeutic-expertise/cardiology</span> <span style="display:none">therapeutic-expertise/other</span> <span style="display:none">solutions</span> <span style="display:none">full-service-cro-biologics</span> <span style="display:none">cro-cell-gene</span> <span style="display:none">therapeutic-expertise/vaccines</span> <span style="display:none">therapeutic-expertise/rare-diseases</span> <span style="display:none">therapeutic-expertise/pediatric-clinical-trials</span> <span style="display:none">decentralizedclinicaltrials</span> <span style="display:none">clinical-trial-rescue-programs</span> <span style="display:none">services/full-service-solutions</span> <span style="display:none">clinical-trial-planning</span> <span style="display:none">clinical-trial-conduct</span> <span style="display:none">regulatory-submission</span> <span style="display:none">solutions/natural-history-studies</span> <span style="display:none">services</span> <span style="display:none">services/strategic-consulting</span> <span 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style="display:none">blog</span> <span style="display:none"></span> <span style="display:none"></span> <span style="display:none"></span> <span style="display:none">latest-newsletter</span> <span style="display:none">contact-us</span> <span style="display:none">rfp</span> <!-- loop in main nav and get lastest item menu label --> <span style="display:none"> regulatory-consulting-for-program-and-trial-design </span> Regulatory Consulting <!-- if lastest item menu label empty => get default one in url--> </div> </div> </div> </div> </div> <!-- End breadcrumb--><div class="custom " style=" max-width: 1140px; margin: auto;"> <div class="row"> <div data-wow-delay="none" class="wow none col-sm-12 c1 "> <div class="col-inner"> <div class="hhs-rich-text-in"> <div class="hhs-rich-text"> <p style="text-align: left;">Our Regulatory experts provide regulatory guidance for product and program development through to the successful interactions with the FDA or other global regulatory agencies. We focus on helping you with:</p> <h4 style="text-align: left;">Strategic Program Planning</h4> <ul> <li style="text-align: left;">Develop the regulatory strategy and submission plan to support both US and global registrations</li> <li style="text-align: left;">Explore the possibility of<span> </span><a href="https://www.veristat.com/library/fda-expedited-pathways-explained" rel="nofollow noopener" target="_blank">pursuing expedited or alternate regulatory pathways for faster approval</a>, and writing the corresponding applications</li> <li style="text-align: left;">Create non-clinical development plans</li> <li style="text-align: left;">Assist in Contract Manufacturing Organization (CMO) selection, write and review full <a href="https://artpodcast.expert/podcast/cmc-pitfalls-from-benchtop-to-ind" rel="noopener" target="_blank">Chemistry, Manufacturing and Controls (CMC) sections</a> for submissions (Module 3, Module 2.3), and perform overall gap analysis</li> <li style="text-align: left;">Write and review the clinical development plans including trial design, sample size calculations, protocols, investigator brochures, electronic Case Report Forms (eCRFs), Statistical Analysis Plans (SAP) or Interim analysis plans (IAP)</li> <li style="text-align: left;">Draft regulatory agency, board meeting, or investor presentations of the clinical development, CMC, regulatory and/or statistical plans</li> </ul> </div> </div> </div> </div> </div> </div> <span class="hhs-row-overlay"></span> </div> <!-- MODAL POP UP FOR COL 1 ----> <!-- MODAL POP UP FOR COL 2 ----> <!-- MODAL POP UP FOR COL 3 ----> <!-- MODAL POP UP FOR COL 4 ----> <!-- ASYNC CSS LOAD ---> </div> </div><!--end widget-span --> </div><!--end row--> </div><!--end row-wrapper --> </div><!--end widget-span --> <div class="span6 widget-span widget-type-cell dnd-column" style="" data-widget-type="cell" data-x="6" data-w="6"> <div class="row-fluid-wrapper row-depth-1 row-number-10 dnd-row"> <div class="row-fluid "> 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https://www.veristat.com/hs-fs/hubfs/Veristat_icon_regulatory%20approval.png?width=100&height=100&name=Veristat_icon_regulatory%20approval.png 100w, https://www.veristat.com/hs-fs/hubfs/Veristat_icon_regulatory%20approval.png?width=150&height=150&name=Veristat_icon_regulatory%20approval.png 150w, https://www.veristat.com/hs-fs/hubfs/Veristat_icon_regulatory%20approval.png?width=200&height=200&name=Veristat_icon_regulatory%20approval.png 200w, https://www.veristat.com/hs-fs/hubfs/Veristat_icon_regulatory%20approval.png?width=250&height=250&name=Veristat_icon_regulatory%20approval.png 250w, https://www.veristat.com/hs-fs/hubfs/Veristat_icon_regulatory%20approval.png?width=300&height=300&name=Veristat_icon_regulatory%20approval.png 300w" sizes="(max-width: 100px) 100vw, 100px"> <div class="hhs-testimonial-content"> <blockquote>Scientific-Minded Expertise</blockquote> <h5>Veristat's Regulatory, statistical, medical/safety and communications experts prepared 165+ INDs/CTAs in the past 5 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style="display:none">contact-us</span> <span style="display:none">rfp</span> <!-- loop in main nav and get lastest item menu label --> <span style="display:none"> regulatory-consulting-for-program-and-trial-design </span> Regulatory Consulting <!-- if lastest item menu label empty => get default one in url--> </div> </div> </div> </div> </div> <!-- End breadcrumb--><div class="container " style=""> <div class="row"> <div data-wow-delay="none" class="wow none col-lg-4 col-md-12 c1 "> <div class="col-inner"> <div class="hhs-rich-text-in"> <div class="hhs-rich-text"> <h4>IND/CTA Writing, Gap Analysis, and Publishing</h4> <ul> <li>Protocol & Investigator Brochures</li> <li>Administrative documentation (module 1)</li> <li>General investigational plan</li> <li><a href="https://artpodcast.expert/podcast/cmc-pitfalls-from-benchtop-to-ind" rel="noopener" target="_blank">CMC</a> Writing</li> <li>Non-Clinical</li> <li><a href="/services/regulatory-affairs/regulatory-publishing" rel="noopener">Publishing of INDs and CTAs</a> to regulatory agencies</li> </ul> </div> </div> </div> </div> <div data-wow-delay="none" class="wow none col-lg-4 col-md-12 c2 "> <div class="col-inner"> <div class="hhs-rich-text-in"> <div class="hhs-rich-text"> <h4>Regulatory Agency Meeting Preparation & Support</h4> <ul> <li>Develop strategy and questions for regulatory agency interactions</li> <li>Write and submit meeting request letter and briefing packages</li> <li>Facilitate communications with FDA as regulatory representative or US Agent</li> <li>Prepare regulatory agency meeting logistics (face to face meetings for rehearsals, transportation to FDA, bar codes for FDA building entry, foreign visitor forms, etc.)</li> <li><a href="https://www.veristat.com/services/regulatory-affairs/regulatory-agency-meeting-support" rel="noopener" target="_blank">Plan and support FDA meeting rehearsals, face to face and teleconferences</a></li> <li><a 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