Chemistry, Manufacturing, and Controls (CMC) Regulatory Consulting

<!doctype html><html lang="en"><head> <meta charset="utf-8"> <title>Chemistry, Manufacturing, and Controls (CMC) Regulatory Consulting</title> <link rel="shortcut icon" href="https://www.veristat.com/hubfs/favicon.ico"> <meta name="description" content="Strategic product development and CMC regulatory planning start early on at the pre-IND stage and apply to the entire development lifecycle through to post-approval."> <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="Strategic product development and CMC regulatory planning start early on at the pre-IND stage and apply to the entire development lifecycle through to post-approval."> <meta property="og:title" content="Chemistry, Manufacturing, and Controls (CMC) Regulatory Consulting"> <meta name="twitter:description" content="Strategic product development and CMC regulatory planning start early on at the pre-IND stage and apply to the entire development lifecycle through to post-approval."> <meta name="twitter:title" content="Chemistry, Manufacturing, and Controls (CMC) Regulatory Consulting"> <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); padding: 12px 0; } .hhs-top-bar.sticky-menu.active { padding: 12px 0; } /* LOGOS */ .hhs-top-bar.hhs-alt-nav .logo-sticky, .logo-standard { max-width: 220px; float: left; } .hhs-top-bar.hhs-alt-nav.sticky-menu.active .logo-sticky, .logo-sticky { max-width: 240px; float: left; } .hhs-header-logo { padding-top: 0px; } /* MENU STYLE */ .hhs-nav-grid__menu { margin: 0 auto; } .hhs-top-bar .hs-menu-wrapper.hs-menu-flow-horizontal>ul li a, .hs-menu-wrapper.hs-menu-flow-horizontal ul.hhs-nav-links .hs-menu-item a { color: rgba(74, 74, 74, 1.0); } .hhs-top-bar .hs-menu-wrapper.hs-menu-flow-horizontal>ul li { margin: 15px 10px; } .hhs-top-bar .hs-menu-wrapper.hs-menu-flow-horizontal>ul li a:hover, .hs-menu-wrapper.hs-menu-flow-horizontal ul.hhs-nav-links .hs-menu-item a:hover, .hhs-top-bar .hs-menu-wrapper.hs-menu-flow-horizontal>ul li a:hover, .hhs-header-search a i:hover, .hhs-lang-switch .globe_class:hover{ color: rgba(153, 153, 153, 1.0); } .hhs-header-search a i{ color: rgba(74, 74, 74, 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_1648233536234 .hhs-text-mod { padding-top: 50px; padding-bottom: 50px;background-color: rgba(#null, 0.0);} @media (max-width: 768px) { #hs_cos_wrapper_widget_1648233536234 .hhs-text-mod { padding-top: 50px; padding-bottom: 50px; } } @media (max-width: 575px) { #hs_cos_wrapper_widget_1648233536234 .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_1648233536234 .c1 .hhs-rich-text, #hs_cos_wrapper_widget_1648233536234 .c1 .hhs-rich-text h1, #hs_cos_wrapper_widget_1648233536234 .c1 .hhs-rich-text h2,#hs_cos_wrapper_widget_1648233536234 .c1 .hhs-rich-text h3, #hs_cos_wrapper_widget_1648233536234 .c1 .hhs-rich-text h4, #hs_cos_wrapper_widget_1648233536234 .c1 .hhs-rich-text h5, #hs_cos_wrapper_widget_1648233536234 .c1 .hhs-rich-text h6, #hs_cos_wrapper_widget_1648233536234 .c1 .hhs-rich-text p, #hs_cos_wrapper_widget_1648233536234 .c1 .hhs-rich-text span, #hs_cos_wrapper_widget_1648233536234 .c1 .hhs-rich-text li, #hs_cos_wrapper_widget_1648233536234 .c1 .hhs-rich-text blockquote {text-align: left; }@media (max-width: 992px) { #hs_cos_wrapper_widget_1648233536234 .c1 .hhs-rich-text h1, #hs_cos_wrapper_widget_1648233536234 .c1 .hhs-rich-text h2,#hs_cos_wrapper_widget_1648233536234 .c1 .hhs-rich-text h3, #hs_cos_wrapper_widget_1648233536234 .c1 .hhs-rich-text h4, #hs_cos_wrapper_widget_1648233536234 .c1 .hhs-rich-text h5, #hs_cos_wrapper_widget_1648233536234 .c1 .hhs-rich-text h6, #hs_cos_wrapper_widget_1648233536234 .c1 .hhs-rich-text p, #hs_cos_wrapper_widget_1648233536234 .c1 .hhs-rich-text span, #hs_cos_wrapper_widget_1648233536234 .c1 .hhs-rich-text li { text-align: left; } } @media (max-width: 575px) { #hs_cos_wrapper_widget_1648233536234 .c1 .hhs-rich-text h1, #hs_cos_wrapper_widget_1648233536234 .c1 .hhs-rich-text h2,#hs_cos_wrapper_widget_1648233536234 .c1 .hhs-rich-text h3, #hs_cos_wrapper_widget_1648233536234 .c1 .hhs-rich-text h4, #hs_cos_wrapper_widget_1648233536234 .c1 .hhs-rich-text h5, #hs_cos_wrapper_widget_1648233536234 .c1 .hhs-rich-text h6, #hs_cos_wrapper_widget_1648233536234 .c1 .hhs-rich-text p, #hs_cos_wrapper_widget_1648233536234 .c1 .hhs-rich-text span, #hs_cos_wrapper_widget_1648233536234 .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_module_16849385202273 .hhs-text-mod { padding-top: 50px; padding-bottom: 10px;background-color: rgba(255, 255, 255, 1);} @media (max-width: 768px) { #hs_cos_wrapper_module_16849385202273 .hhs-text-mod { padding-top: 50px; padding-bottom: 50px; } } @media (max-width: 575px) { #hs_cos_wrapper_module_16849385202273 .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_module_16849385202273 .c1 .hhs-rich-text, #hs_cos_wrapper_module_16849385202273 .c1 .hhs-rich-text h1, #hs_cos_wrapper_module_16849385202273 .c1 .hhs-rich-text h2,#hs_cos_wrapper_module_16849385202273 .c1 .hhs-rich-text h3, #hs_cos_wrapper_module_16849385202273 .c1 .hhs-rich-text h4, #hs_cos_wrapper_module_16849385202273 .c1 .hhs-rich-text h5, #hs_cos_wrapper_module_16849385202273 .c1 .hhs-rich-text h6, #hs_cos_wrapper_module_16849385202273 .c1 .hhs-rich-text p, #hs_cos_wrapper_module_16849385202273 .c1 .hhs-rich-text span, #hs_cos_wrapper_module_16849385202273 .c1 .hhs-rich-text li, #hs_cos_wrapper_module_16849385202273 .c1 .hhs-rich-text blockquote {text-align: left; }@media (max-width: 992px) { #hs_cos_wrapper_module_16849385202273 .c1 .hhs-rich-text h1, #hs_cos_wrapper_module_16849385202273 .c1 .hhs-rich-text h2,#hs_cos_wrapper_module_16849385202273 .c1 .hhs-rich-text h3, #hs_cos_wrapper_module_16849385202273 .c1 .hhs-rich-text h4, #hs_cos_wrapper_module_16849385202273 .c1 .hhs-rich-text h5, #hs_cos_wrapper_module_16849385202273 .c1 .hhs-rich-text h6, #hs_cos_wrapper_module_16849385202273 .c1 .hhs-rich-text p, #hs_cos_wrapper_module_16849385202273 .c1 .hhs-rich-text span, #hs_cos_wrapper_module_16849385202273 .c1 .hhs-rich-text li { text-align: left; } } @media (max-width: 575px) { #hs_cos_wrapper_module_16849385202273 .c1 .hhs-rich-text h1, #hs_cos_wrapper_module_16849385202273 .c1 .hhs-rich-text h2,#hs_cos_wrapper_module_16849385202273 .c1 .hhs-rich-text h3, #hs_cos_wrapper_module_16849385202273 .c1 .hhs-rich-text h4, #hs_cos_wrapper_module_16849385202273 .c1 .hhs-rich-text h5, #hs_cos_wrapper_module_16849385202273 .c1 .hhs-rich-text h6, #hs_cos_wrapper_module_16849385202273 .c1 .hhs-rich-text p, #hs_cos_wrapper_module_16849385202273 .c1 .hhs-rich-text span, #hs_cos_wrapper_module_16849385202273 .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_module_16849386317713 .hhs-text-mod { padding-top: 50px; padding-bottom: 10px;background-color: rgba(255, 255, 255, 1);} @media (max-width: 768px) { #hs_cos_wrapper_module_16849386317713 .hhs-text-mod { padding-top: 50px; padding-bottom: 50px; } } @media (max-width: 575px) { #hs_cos_wrapper_module_16849386317713 .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_module_16849386317713 .c1 .hhs-rich-text, #hs_cos_wrapper_module_16849386317713 .c1 .hhs-rich-text h1, #hs_cos_wrapper_module_16849386317713 .c1 .hhs-rich-text h2,#hs_cos_wrapper_module_16849386317713 .c1 .hhs-rich-text h3, #hs_cos_wrapper_module_16849386317713 .c1 .hhs-rich-text h4, #hs_cos_wrapper_module_16849386317713 .c1 .hhs-rich-text h5, #hs_cos_wrapper_module_16849386317713 .c1 .hhs-rich-text h6, #hs_cos_wrapper_module_16849386317713 .c1 .hhs-rich-text p, #hs_cos_wrapper_module_16849386317713 .c1 .hhs-rich-text span, #hs_cos_wrapper_module_16849386317713 .c1 .hhs-rich-text li, #hs_cos_wrapper_module_16849386317713 .c1 .hhs-rich-text blockquote {text-align: left; }@media (max-width: 992px) { #hs_cos_wrapper_module_16849386317713 .c1 .hhs-rich-text h1, #hs_cos_wrapper_module_16849386317713 .c1 .hhs-rich-text h2,#hs_cos_wrapper_module_16849386317713 .c1 .hhs-rich-text h3, #hs_cos_wrapper_module_16849386317713 .c1 .hhs-rich-text h4, #hs_cos_wrapper_module_16849386317713 .c1 .hhs-rich-text h5, #hs_cos_wrapper_module_16849386317713 .c1 .hhs-rich-text h6, #hs_cos_wrapper_module_16849386317713 .c1 .hhs-rich-text p, #hs_cos_wrapper_module_16849386317713 .c1 .hhs-rich-text span, #hs_cos_wrapper_module_16849386317713 .c1 .hhs-rich-text li { text-align: left; } } @media (max-width: 575px) { #hs_cos_wrapper_module_16849386317713 .c1 .hhs-rich-text h1, #hs_cos_wrapper_module_16849386317713 .c1 .hhs-rich-text h2,#hs_cos_wrapper_module_16849386317713 .c1 .hhs-rich-text h3, #hs_cos_wrapper_module_16849386317713 .c1 .hhs-rich-text h4, #hs_cos_wrapper_module_16849386317713 .c1 .hhs-rich-text h5, #hs_cos_wrapper_module_16849386317713 .c1 .hhs-rich-text h6, #hs_cos_wrapper_module_16849386317713 .c1 .hhs-rich-text p, #hs_cos_wrapper_module_16849386317713 .c1 .hhs-rich-text span, #hs_cos_wrapper_module_16849386317713 .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_module_16849386317713 .c2 .hhs-rich-text,#hs_cos_wrapper_module_16849386317713 .c2 .hhs-rich-text h1, #hs_cos_wrapper_module_16849386317713 .c2 .hhs-rich-text h2,#hs_cos_wrapper_module_16849386317713 .c2 .hhs-rich-text h3, #hs_cos_wrapper_module_16849386317713 .c2 .hhs-rich-text h4, #hs_cos_wrapper_module_16849386317713 .c2 .hhs-rich-text h5, #hs_cos_wrapper_module_16849386317713 .c2 .hhs-rich-text h6, #hs_cos_wrapper_module_16849386317713 .c2 .hhs-rich-text p, #hs_cos_wrapper_module_16849386317713 .c2 .hhs-rich-text span, #hs_cos_wrapper_module_16849386317713 .c2 .hhs-rich-text li, #hs_cos_wrapper_module_16849386317713 .c2 .hhs-rich-text blockquote {text-align: right; }@media (max-width: 992px) { #hs_cos_wrapper_module_16849386317713 .c2 .hhs-rich-text h1, #hs_cos_wrapper_module_16849386317713 .c2 .hhs-rich-text h2,#hs_cos_wrapper_module_16849386317713 .c2 .hhs-rich-text h3, #hs_cos_wrapper_module_16849386317713 .c2 .hhs-rich-text h4, #hs_cos_wrapper_module_16849386317713 .c2 .hhs-rich-text h5, #hs_cos_wrapper_module_16849386317713 .c2 .hhs-rich-text h6, #hs_cos_wrapper_module_16849386317713 .c2 .hhs-rich-text p, #hs_cos_wrapper_module_16849386317713 .c2 .hhs-rich-text span, #hs_cos_wrapper_module_16849386317713 .c2 .hhs-rich-text li { text-align: center; } } @media (max-width: 575px) { #hs_cos_wrapper_module_16849386317713 .c2 .hhs-rich-text h1, #hs_cos_wrapper_module_16849386317713 .c2 .hhs-rich-text h2,#hs_cos_wrapper_module_16849386317713 .c2 .hhs-rich-text h3, #hs_cos_wrapper_module_16849386317713 .c2 .hhs-rich-text h4, #hs_cos_wrapper_module_16849386317713 .c2 .hhs-rich-text h5, #hs_cos_wrapper_module_16849386317713 .c2 .hhs-rich-text h6, #hs_cos_wrapper_module_16849386317713 .c2 .hhs-rich-text p, #hs_cos_wrapper_module_16849386317713 .c2 .hhs-rich-text span, #hs_cos_wrapper_module_16849386317713 .c2 .hhs-rich-text li { text-align: center; } } /* BACKGROUND *//* SPACING *//* PULL UP CONTENT OPTION *//* FORM STYLE *//* DIVIDER *//* VERTICAL ALIGN *//* MODAL */ /******************************* END *******************************/ /******************************* COLUMN 3 *******************************/ /******************************* END *******************************/ /******************************* COLUMN 4 *******************************/ /******************************* END *******************************/ </style> <style> /******************************* ROW STYLE *******************************/ #hs_cos_wrapper_widget_1684942031869 .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_1684942031869 .hhs-testimonial-card-mod { padding-top: 50px; padding-bottom: 50px; } } @media (max-width: 575px) { #hs_cos_wrapper_widget_1684942031869 .hhs-testimonial-card-mod { padding-top: 25px; padding-bottom: 25px; } } /* SHADOW */ /* PARALLAX */ /* OVERLAY */ /* PULL UP */ /* WAVE *//******************************* END *******************************/ /******************************* CARD STYLE *******************************/ #hs_cos_wrapper_widget_1684942031869 .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_1684942031869 .hhs-testimonial-content { padding: 0px; text-align: center; } #hs_cos_wrapper_widget_1684942031869 .hhs-testimonial-card blockquote {font-size: 24px;} #hs_cos_wrapper_widget_1684942031869 .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_1684942031869 .star-rating .star-solid { color: #f1a604; } #hs_cos_wrapper_widget_1684942031869 .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_module_1684939388277 .hhs-text-mod { padding-top: 50px; padding-bottom: 10px;background-color: rgba(255, 255, 255, 1);} @media (max-width: 768px) { #hs_cos_wrapper_module_1684939388277 .hhs-text-mod { padding-top: 50px; padding-bottom: 50px; } } @media (max-width: 575px) { #hs_cos_wrapper_module_1684939388277 .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_module_1684939388277 .c1 .hhs-rich-text, #hs_cos_wrapper_module_1684939388277 .c1 .hhs-rich-text h1, #hs_cos_wrapper_module_1684939388277 .c1 .hhs-rich-text h2,#hs_cos_wrapper_module_1684939388277 .c1 .hhs-rich-text h3, #hs_cos_wrapper_module_1684939388277 .c1 .hhs-rich-text h4, #hs_cos_wrapper_module_1684939388277 .c1 .hhs-rich-text h5, #hs_cos_wrapper_module_1684939388277 .c1 .hhs-rich-text h6, #hs_cos_wrapper_module_1684939388277 .c1 .hhs-rich-text p, #hs_cos_wrapper_module_1684939388277 .c1 .hhs-rich-text span, #hs_cos_wrapper_module_1684939388277 .c1 .hhs-rich-text li, #hs_cos_wrapper_module_1684939388277 .c1 .hhs-rich-text blockquote {text-align: left; }@media (max-width: 992px) { #hs_cos_wrapper_module_1684939388277 .c1 .hhs-rich-text h1, #hs_cos_wrapper_module_1684939388277 .c1 .hhs-rich-text h2,#hs_cos_wrapper_module_1684939388277 .c1 .hhs-rich-text h3, #hs_cos_wrapper_module_1684939388277 .c1 .hhs-rich-text h4, #hs_cos_wrapper_module_1684939388277 .c1 .hhs-rich-text h5, #hs_cos_wrapper_module_1684939388277 .c1 .hhs-rich-text h6, #hs_cos_wrapper_module_1684939388277 .c1 .hhs-rich-text p, #hs_cos_wrapper_module_1684939388277 .c1 .hhs-rich-text span, #hs_cos_wrapper_module_1684939388277 .c1 .hhs-rich-text li { text-align: left; } } @media (max-width: 575px) { #hs_cos_wrapper_module_1684939388277 .c1 .hhs-rich-text h1, #hs_cos_wrapper_module_1684939388277 .c1 .hhs-rich-text h2,#hs_cos_wrapper_module_1684939388277 .c1 .hhs-rich-text h3, #hs_cos_wrapper_module_1684939388277 .c1 .hhs-rich-text h4, #hs_cos_wrapper_module_1684939388277 .c1 .hhs-rich-text h5, #hs_cos_wrapper_module_1684939388277 .c1 .hhs-rich-text h6, #hs_cos_wrapper_module_1684939388277 .c1 .hhs-rich-text p, #hs_cos_wrapper_module_1684939388277 .c1 .hhs-rich-text span, #hs_cos_wrapper_module_1684939388277 .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_module_16849394701333 .hhs-text-mod { padding-top: 50px; padding-bottom: 10px;background-repeat: no-repeat; background-size: cover; background-position: left center;} @media (max-width: 768px) { #hs_cos_wrapper_module_16849394701333 .hhs-text-mod { padding-top: 50px; padding-bottom: 50px; } } @media (max-width: 575px) { #hs_cos_wrapper_module_16849394701333 .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_module_16849394701333 .c1 .hhs-rich-text, #hs_cos_wrapper_module_16849394701333 .c1 .hhs-rich-text h1, #hs_cos_wrapper_module_16849394701333 .c1 .hhs-rich-text h2,#hs_cos_wrapper_module_16849394701333 .c1 .hhs-rich-text h3, #hs_cos_wrapper_module_16849394701333 .c1 .hhs-rich-text h4, #hs_cos_wrapper_module_16849394701333 .c1 .hhs-rich-text h5, #hs_cos_wrapper_module_16849394701333 .c1 .hhs-rich-text h6, #hs_cos_wrapper_module_16849394701333 .c1 .hhs-rich-text p, #hs_cos_wrapper_module_16849394701333 .c1 .hhs-rich-text span, #hs_cos_wrapper_module_16849394701333 .c1 .hhs-rich-text li, #hs_cos_wrapper_module_16849394701333 .c1 .hhs-rich-text blockquote {text-align: left; }@media (max-width: 992px) { #hs_cos_wrapper_module_16849394701333 .c1 .hhs-rich-text h1, #hs_cos_wrapper_module_16849394701333 .c1 .hhs-rich-text h2,#hs_cos_wrapper_module_16849394701333 .c1 .hhs-rich-text h3, #hs_cos_wrapper_module_16849394701333 .c1 .hhs-rich-text h4, #hs_cos_wrapper_module_16849394701333 .c1 .hhs-rich-text h5, #hs_cos_wrapper_module_16849394701333 .c1 .hhs-rich-text h6, #hs_cos_wrapper_module_16849394701333 .c1 .hhs-rich-text p, #hs_cos_wrapper_module_16849394701333 .c1 .hhs-rich-text span, #hs_cos_wrapper_module_16849394701333 .c1 .hhs-rich-text li { text-align: left; } } @media (max-width: 575px) { #hs_cos_wrapper_module_16849394701333 .c1 .hhs-rich-text h1, #hs_cos_wrapper_module_16849394701333 .c1 .hhs-rich-text h2,#hs_cos_wrapper_module_16849394701333 .c1 .hhs-rich-text h3, #hs_cos_wrapper_module_16849394701333 .c1 .hhs-rich-text h4, #hs_cos_wrapper_module_16849394701333 .c1 .hhs-rich-text h5, #hs_cos_wrapper_module_16849394701333 .c1 .hhs-rich-text h6, #hs_cos_wrapper_module_16849394701333 .c1 .hhs-rich-text p, #hs_cos_wrapper_module_16849394701333 .c1 .hhs-rich-text span, #hs_cos_wrapper_module_16849394701333 .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_module_16849395779593 .hhs-text-mod { padding-top: 50px; padding-bottom: 10px;background-color: rgba(255, 255, 255, 1);} @media (max-width: 768px) { #hs_cos_wrapper_module_16849395779593 .hhs-text-mod { padding-top: 50px; padding-bottom: 50px; } } @media (max-width: 575px) { #hs_cos_wrapper_module_16849395779593 .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_module_16849395779593 .c1 .hhs-rich-text, #hs_cos_wrapper_module_16849395779593 .c1 .hhs-rich-text h1, #hs_cos_wrapper_module_16849395779593 .c1 .hhs-rich-text h2,#hs_cos_wrapper_module_16849395779593 .c1 .hhs-rich-text h3, #hs_cos_wrapper_module_16849395779593 .c1 .hhs-rich-text h4, #hs_cos_wrapper_module_16849395779593 .c1 .hhs-rich-text h5, #hs_cos_wrapper_module_16849395779593 .c1 .hhs-rich-text h6, #hs_cos_wrapper_module_16849395779593 .c1 .hhs-rich-text p, #hs_cos_wrapper_module_16849395779593 .c1 .hhs-rich-text span, #hs_cos_wrapper_module_16849395779593 .c1 .hhs-rich-text li, #hs_cos_wrapper_module_16849395779593 .c1 .hhs-rich-text blockquote {text-align: left; }@media (max-width: 992px) { #hs_cos_wrapper_module_16849395779593 .c1 .hhs-rich-text h1, #hs_cos_wrapper_module_16849395779593 .c1 .hhs-rich-text h2,#hs_cos_wrapper_module_16849395779593 .c1 .hhs-rich-text h3, #hs_cos_wrapper_module_16849395779593 .c1 .hhs-rich-text h4, #hs_cos_wrapper_module_16849395779593 .c1 .hhs-rich-text h5, #hs_cos_wrapper_module_16849395779593 .c1 .hhs-rich-text h6, #hs_cos_wrapper_module_16849395779593 .c1 .hhs-rich-text p, #hs_cos_wrapper_module_16849395779593 .c1 .hhs-rich-text span, #hs_cos_wrapper_module_16849395779593 .c1 .hhs-rich-text li { text-align: left; } } @media (max-width: 575px) { #hs_cos_wrapper_module_16849395779593 .c1 .hhs-rich-text h1, #hs_cos_wrapper_module_16849395779593 .c1 .hhs-rich-text h2,#hs_cos_wrapper_module_16849395779593 .c1 .hhs-rich-text h3, #hs_cos_wrapper_module_16849395779593 .c1 .hhs-rich-text h4, #hs_cos_wrapper_module_16849395779593 .c1 .hhs-rich-text h5, #hs_cos_wrapper_module_16849395779593 .c1 .hhs-rich-text h6, #hs_cos_wrapper_module_16849395779593 .c1 .hhs-rich-text p, #hs_cos_wrapper_module_16849395779593 .c1 .hhs-rich-text span, #hs_cos_wrapper_module_16849395779593 .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_1684942142638 .hhs-tab-mod { padding-top: 50px; padding-bottom: 50px; background-color: rgba(255, 255, 255, 1); } @media (max-width: 768px) { #hs_cos_wrapper_widget_1684942142638 .hhs-tab-mod { padding-top: 50px; padding-bottom: 50px; } } @media (max-width: 575px) { #hs_cos_wrapper_widget_1684942142638 .hhs-tab-mod { padding-top: 25px; padding-bottom: 25px; } } /* SHADOW */ /* PARALLAX */ /* OVERLAY *//* WAVE *//******************************* END *******************************/ /******************************* TAB STYLE *******************************/ /* TABS */ #hs_cos_wrapper_widget_1684942142638 .hhs-tab-wrapper button { background-color: rgba(238, 238, 238, 1.0); color: rgba(102, 102, 102, 1.0); border-top: 3px solid rgba(238, 238, 238, 1.0); font-size: 18px; font-weight: bold; } #hs_cos_wrapper_widget_1684942142638 .selected-tab, #hs_cos_wrapper_widget_1684942142638 .hhs-tab-wrapper button.is-active, #hs_cos_wrapper_widget_1684942142638 .hhs-tab-wrapper button:focus, #hs_cos_wrapper_widget_1684942142638 .hhs-tab-wrapper button:active { background-color: rgba(255, 255, 255, 1.0); 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} } @media (max-width: 575px) { #hs_cos_wrapper_module_16849407850152 .c2 .hhs-rich-text h1, #hs_cos_wrapper_module_16849407850152 .c2 .hhs-rich-text h2,#hs_cos_wrapper_module_16849407850152 .c2 .hhs-rich-text h3, #hs_cos_wrapper_module_16849407850152 .c2 .hhs-rich-text h4, #hs_cos_wrapper_module_16849407850152 .c2 .hhs-rich-text h5, #hs_cos_wrapper_module_16849407850152 .c2 .hhs-rich-text h6, #hs_cos_wrapper_module_16849407850152 .c2 .hhs-rich-text p, #hs_cos_wrapper_module_16849407850152 .c2 .hhs-rich-text span, #hs_cos_wrapper_module_16849407850152 .c2 .hhs-rich-text li { text-align: center; } } /* BACKGROUND *//* SPACING *//* PULL UP CONTENT OPTION *//* FORM STYLE *//* DIVIDER *//* VERTICAL ALIGN *//* MODAL */ /******************************* END *******************************/ /******************************* COLUMN 3 *******************************/ /******************************* END *******************************/ /******************************* COLUMN 4 *******************************/ /******************************* END *******************************/ </style> <style> #hs_cos_wrapper_module_16769317074323 .hhs-text-mod { padding-top: 50px; 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Regulatory Consulting</h2> <h1><strong>Phase-Appropriate CMC Support from pre-IND Through Commercialization</strong></h1> <p>Strategic product development and CMC regulatory planning start early on at the pre-IND stage and apply to the entire development lifecycle through to post-approval. Planning manufacturing and analytical programs and generating the required documentation are crucial to successfully supporting regulatory filings in a cost and time-effective manner and ensuring that FDA regulators support your development plan.<br><br>Whether you are preparing for an IND, getting ready to file a marketing application, or need to make post-marketing changes, Veristat regulatory experts are experienced in helping sponsors establish CMC strategies designed to meet FDA requirements.<br><br></p> <p><span class="hs-cta-wrapper" id="hs-cta-wrapper-cf72e8aa-8333-4b21-89f8-2f6d2a59be96"><span class="hs-cta-node hs-cta-cf72e8aa-8333-4b21-89f8-2f6d2a59be96" id="hs-cta-cf72e8aa-8333-4b21-89f8-2f6d2a59be96"><a href="https://cta-redirect.hubspot.com/cta/redirect/1333476/cf72e8aa-8333-4b21-89f8-2f6d2a59be96"><img class="hs-cta-img" id="hs-cta-img-cf72e8aa-8333-4b21-89f8-2f6d2a59be96" style="border-width:0px;" 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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>  <span style="display:none"> chemistry-manufacturing-controls-cmc </span> Chemistry, Manufacturing, and Controls (CMC)  </div> </div> </div> </div> </div> <div class="custom " style=" max-width: 1140px; margin: auto;"> <div class="row"> <div data-wow-delay="none" class="wow none col-lg-4 col-sm-12 c1 "> <div class="col-inner"> <div class="hhs-rich-text-in"> <div class="hhs-rich-text"> <p>Without comprehensive strategic planning and proper documentation, INDs can be placed on <a href="/library/helping-a-sponsor-overcome-a-partial-clinical-hold-and-seamlessly-steer-multiple-products-through-development" rel="noopener" target="_blank">clinical hold</a> for failing to properly demonstrate phase-appropriate CMC safety and quality requirements. Many NDA/BLA approvals also get delayed due to failure to address agency expectations or requests regarding manufacturing issues.<br><br>To help you overcome CMC challenges, Veristat is poised to support your manufacturing,</p> </div> </div> </div> </div> <div data-wow-delay="none" class="wow none col-lg-8 col-sm-12 c2 "> <div class="col-inner"> <div class="hhs-rich-text-in"> <div class="hhs-rich-text"> <ul> <li style="text-align: left;"><span></span>Support for established programs where additional CMC team members are needed.</li> <li style="text-align: left;"><span></span>Comprehensive CMC strategic development plans and submission filing plans.</li> <li style="text-align: left;"><span></span>Development of your analytical and characterization studies and stability programs needed to support clinical use.</li> <li style="text-align: left;"><span></span>Planning of batch size and disposition to meet all analytical, non-clinical, and clinical needs, including projection of appropriate overages to cover manufacturing losses and unforeseen analytical and clinical use.</li> <li style="text-align: left;"><span></span>Guidance on the required source documentation needed for IND and marketing application.</li> <li style="text-align: left;"><span></span>CMC submission and program Gap Analysis</li> <li style="text-align: left;"><span></span>CMC Technical Writing from meeting packages to market applications</li> <li style="text-align: left;"><span></span>Generation of <a href="/blog/unlock-the-secrets-of-effective-sd-file-preparation-for-fda-submissions" rel="noopener" target="_blank">Structure Data (SD) Files</a> that are now required for NDAs, DMFs, and ANDAs, for the FDA’s KASA review program, and strongly encouraged for other CMC submissions.</li> <li style="text-align: left;"><span></span>Prepare, lead, and facilitate CMC interactions with FDA.</li> </ul> </div> </div> </div> </div> </div> </div> <span class="hhs-row-overlay"></span> </div>      </div> </div> </div> </div> <div class="row-fluid-wrapper row-depth-1 row-number-8 dnd-row"> <div class="row-fluid "> <div class="span12 widget-span widget-type-custom_widget dnd-module" style="" data-widget-type="custom_widget" data-x="0" data-w="12"> <div id="hs_cos_wrapper_widget_1684942031869" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_module" style="" data-hs-cos-general-type="widget" data-hs-cos-type="module"> <div id="" class="hhs-testimonial-card-mod show-mobile show-tablet show-desktop " style=";"><div class="container " style=""> <div class="row"> <div class="col-lg-12"> <div class="hhs-testimonial-card"> <div class="hhs-testimonial-content"> <blockquote>The FDA guidance regarding Content and Format for INDs for Phase 1 points out, 'The identification of a safety concern or insufficient data to make an evaluation of safety is the only basis for a clinical hold based on the CMC section.</blockquote> <h5>U.S. FDA</h5> <h6></h6> </div> </div> </div> </div> </div> <span 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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 style="text-align: left;">CMC Points to Consider for Sponsors of First Initial IND</h4> <p> </p> <p>As a first-time IND applicant utilizing contract manufacturing, do you have the capacity and experience needed to:</p> <ul> <li><span></span>Develop an effective and efficient CMC program that will meet all current regulatory requirements to support an FIH clinical trial.</li> <li><span></span>Establish an effective regulatory strategy that utilizes appropriate pathways and or accelerated programs.</li> <li><span></span>Select and oversee contract manufacturers.</li> <li><span></span>Work with the manufacturer to establish and optimize the process.</li> <li><span></span>Work with the manufacturer to establish an analytical program appropriate to support a successful IND application.</li> <li><span></span>Work with the manufacturer to generate appropriate manufacturing documentation for the process and analytical programs including batch records, specifications, methods, and reports required to support an IND application. </li> <li><span></span>Author and/or review CMC content for PIND meetings and mediate interactions with the FDA.</li> <li><span></span>Author and/or review quality sections of an IND application.</li> </ul> </div> </div> </div> </div> </div> </div> <span class="hhs-row-overlay"></span> </div>      </div> </div> </div> </div> </div> </div> </div> <div class="row-fluid-wrapper row-depth-1 row-number-11 dnd-section"> <div class="row-fluid "> <div class="span12 widget-span widget-type-cell dnd-column" style="" data-widget-type="cell" data-x="0" data-w="12"> <div class="row-fluid-wrapper row-depth-1 row-number-12 dnd-row"> <div class="row-fluid "> <div class="span12 widget-span widget-type-custom_widget dnd-module" style="" data-widget-type="custom_widget" data-x="0" data-w="12"> <div 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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>  <span style="display:none"> chemistry-manufacturing-controls-cmc </span> Chemistry, Manufacturing, and Controls (CMC)  </div> </div> </div> </div> </div> <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 style="text-align: left;"><span style="color: #ffffff;">Podcast: CMC Pitfalls – From Benchtop to IND</span></h4> <p><span style="color: #ffffff;">Veristat CMC experts outline key fundamentals and pitfalls new sponsors must consider when determining readiness to file an IND from a manufacturing perspective. Listen to the full episode to learn more about how to successfully transition from academic or bench-top production to manufacturing clinical-grade material to support an IND with the FDA.</span></p> <p> </p> <p><span class="hs-cta-wrapper" id="hs-cta-wrapper-073fcf3d-e6ea-400c-b7b0-4b0014218c94"><span class="hs-cta-node hs-cta-073fcf3d-e6ea-400c-b7b0-4b0014218c94" id="hs-cta-073fcf3d-e6ea-400c-b7b0-4b0014218c94"><a href="https://cta-redirect.hubspot.com/cta/redirect/1333476/073fcf3d-e6ea-400c-b7b0-4b0014218c94" target="_blank" rel="noopener"><img class="hs-cta-img" id="hs-cta-img-073fcf3d-e6ea-400c-b7b0-4b0014218c94" style="border-width:0px;" src="https://no-cache.hubspot.com/cta/default/1333476/073fcf3d-e6ea-400c-b7b0-4b0014218c94.png" alt="LISTEN TO PODCAST"></a></span><script charset="utf-8" src="/hs/cta/cta/current.js"></script><script type="text/javascript"> hbspt.cta._relativeUrls=true;hbspt.cta.load(1333476, '073fcf3d-e6ea-400c-b7b0-4b0014218c94', 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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>  <span style="display:none"> chemistry-manufacturing-controls-cmc </span> Chemistry, Manufacturing, and Controls (CMC)  </div> </div> </div> </div> </div> <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 style="text-align: left;">Implement the Right CMC Regulatory Strategy for Your Drug/Biologic</h4> <p style="text-align: left;">Sponsors need to place an equivalent emphasis early on with their CMC or manufacturing development plans as they do their clinical development plans. Although the manufacturing plan is not a required component of an IND submission, carefully mapping out the projected analytical and clinical needs for each stage of development will help you anticipate CMC needs and reduces time delays and unexpected costs.<br><br>Veristat’s scientific-minded team of Regulatory Affairs CMC experts support these focus areas:</p> </div> </div> </div> </div> </div> </div> <span class="hhs-row-overlay"></span> </div>      </div> </div> </div> </div> </div> </div> </div> <div class="row-fluid-wrapper row-depth-1 row-number-14 dnd-section"> <div class="row-fluid "> <div class="span12 widget-span widget-type-cell dnd-column" style="" data-widget-type="cell" data-x="0" data-w="12"> <div class="row-fluid-wrapper row-depth-1 row-number-15 dnd-row"> <div class="row-fluid "> <div class="span12 widget-span widget-type-custom_widget dnd-module" style="" data-widget-type="custom_widget" data-x="0" data-w="12"> <div id="hs_cos_wrapper_widget_1684942142638" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_module" style="" data-hs-cos-general-type="widget" data-hs-cos-type="module"> <div id="" class="hhs-tab-mod show-mobile show-tablet show-desktop " style=";"><div class="container" style=""> <div class="row"> <div class="col-12"> <section class="hhs-tab-content hhs-tabs-block_widget_1684942142638"> <ul class="hhs-tab-wrapper is-d-flex tabs"> <li><button data-target="widget_1684942142638_1" data-open="true" class="selected">Comprehensive CMC Strategic Development from pre-IND to Submission</button></li> <li><button data-target="widget_1684942142638_2">IND and Marketing Applications</button></li> <li><button data-target="widget_1684942142638_3">CMC Meetings and CMC Content for Multi-Disciplinary Meetings</button></li> <li><button data-target="widget_1684942142638_4">Planning for CMC Changes and Comparability Studies</button></li> </ul> <div class="hhs-panel-wrapper"> <div class="panel" data-panel="widget_1684942142638_1"> <div class="row"> <div class="col-12"> <div id="hs_cos_wrapper_widget_1684942142638_" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_inline_rich_text" style="" data-hs-cos-general-type="widget" data-hs-cos-type="inline_rich_text" data-hs-cos-field="col_1.content"><p>Starting at the pre-IND stage, we support you in implementing long-range comprehensive planning for manufacturing and analytical programs to avoid CMC pitfalls that can result in unnecessary costs and extensive program delays.<br><br>Veristat guides sponsors through the planning process taking into consideration the product, the regulatory pathway, CMC requirements, key milestones, potential hurdles and risks, the current regulatory landscape, and business considerations.</p></div> </div></div> </div> <div class="panel" data-panel="widget_1684942142638_2"> <div class="row"> <div class="col-12"> <div id="hs_cos_wrapper_widget_1684942142638_" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_inline_rich_text" style="" data-hs-cos-general-type="widget" data-hs-cos-type="inline_rich_text" data-hs-cos-field="col_1.content"><p>Our Regulatory CMC experts support the authoring and/or review of the Module 3 section of an IND or marketing application by integrating the required content with an appropriate amount of detail in a clear, concise, and easy-to-review format for health authorities.<br><br>Sponsors new to development often fail to realize that CMOs (Contract Manufacturing Organizations) usually do not author regulatory submissions, or if they do, it is not done with the experience of a regulatory CMC expert and the resulting submission could result in information requests, and/or clinical holds.</p></div> </div></div> </div> <div class="panel" data-panel="widget_1684942142638_3"> <div class="row"> <div class="col-12"> <div id="hs_cos_wrapper_widget_1684942142638_" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_inline_rich_text" style="" data-hs-cos-general-type="widget" data-hs-cos-type="inline_rich_text" data-hs-cos-field="col_1.content"><p>Interactions with the FDA regarding CMC are critical, starting with Pre-IND meetings. During the Pre-IND meeting, discussions must take place about any manufacturing techniques where regulations/guidelines don’t exist yet or require flexibility (e.g., complex biologics, cell therapies, etc.)<br><br>Veristat supports the entire process of preparing for, attending, and performing follow-ups for all meetings with FDA that address CMC.</p></div> </div></div> </div> <div class="panel" data-panel="widget_1684942142638_4"> <div class="row"> <div class="col-12"> <div id="hs_cos_wrapper_widget_1684942142638_" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_inline_rich_text" style="" data-hs-cos-general-type="widget" data-hs-cos-type="inline_rich_text" data-hs-cos-field="col_1.content"><p>Manufacturing processes evolve throughout the lifecycle of a development program. Careful planning for the changes to reduce quality and regulatory risk is paramount. Demonstrating that the current product is comparable to the original is necessary with any manufacturing change.<br><br>FDA buy-in on comparability plans is crucial to avoid or reduce the scope of bridging studies. Our regulatory experts support the entire process from preparing for and implementing manufacturing changes to gaining FDA agreement of comparability.</p></div> </div></div> </div> </div> </section> </div> </div> </div> <span class="hhs-row-overlay"></span></div>  </div> </div> </div> </div> </div> </div> </div> <div class="row-fluid-wrapper row-depth-1 row-number-16 dnd-section"> <div class="row-fluid "> <div class="span12 widget-span widget-type-cell dnd-column" style="" data-widget-type="cell" data-x="0" data-w="12"> <div class="row-fluid-wrapper row-depth-1 row-number-17 dnd-row"> <div class="row-fluid "> <div class="span12 widget-span widget-type-custom_widget dnd-module" style="" data-widget-type="custom_widget" data-x="0" data-w="12"> <div id="hs_cos_wrapper_module_16849407850152" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_module" style="" data-hs-cos-general-type="widget" data-hs-cos-type="module">  <div id="" class="hhs-text-mod show-mobile show-tablet 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