Global Regulatory Services & Support - Patheon pharma services

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}); </script> </div> </div> </div> </header> <div class="responsivegrid aem-GridColumn aem-GridColumn--default--12"> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 aem-Grid--medium--12 "> <div class="cmp-hero aem-GridColumn aem-GridColumn--default--12"> <div id="hero" class="pb-5 pt-5 hero-no-hr "> <div class="container-fluid container-lg"> <h1 class="h1 d-inline-block " style="color:;">Global regulatory services and support </h1> <h2 class="h2 d-block" style="color:;"> Unmatched regulatory partner for end-to-end drug Chemistry, Manufacturing & Controls (CMC) strategies and deliverables </h2> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> </div> </div> </div> <style type="text/css"> .cmp-hero #hero h1 span::before { background-color: ; } #hero { min-height: 500px; } </style> <style type="text/css"> #hero { background-image: url('/content/dam/patheon/global/hero-images/regulatory_expertise_hero_v2.jpg'); background-position: left center; } </style> <style type="text/css"> @media (min-width: 576px) { #hero { background-image: url('/content/dam/patheon/global/hero-images/regulatory_expertise_hero_v2.jpg'); background-position: center center; } } </style> <style type="text/css"> @media (min-width: 768px) { #hero { background-image: url('/content/dam/patheon/global/hero-images/regulatory_expertise_hero_v2.jpg'); background-position: center center; } } </style> <style type="text/css"> @media (min-width: 992px) { #hero { background-image: url('/content/dam/patheon/global/hero-images/regulatory_expertise_hero_v2.jpg'); background-position: center center; } } </style> <style type="text/css"> @media (min-width: 1200px) { #hero { background-image: url('/content/dam/patheon/global/hero-images/regulatory_expertise_hero_v2.jpg'); background-position: center center; } } </style> <style type="text/css"> @media (min-width: 1400px) { #hero { background-image: url('/content/dam/patheon/global/hero-images/regulatory_expertise_hero_v2.jpg'); background-position: center center; } } </style> </div> <div class="cmp-well aem-GridColumn--offset--medium--0 aem-GridColumn--medium--none aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--default--12"> <div class="well " style="background-position-x: center;background-position-y: center;" id="well-1067269820"> <div class="container-fluid container-lg "> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 aem-Grid--medium--12 "> <div class="cmp-container aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--default--12"> <div class="cmp-container-inner " id="container-813483950"> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 aem-Grid--medium--12 "> <div class="text aem-GridColumn--offset--medium--0 aem-GridColumn--medium--none aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--default--12"> <div id="text-e522962c1e" class="cmp-text list-style-bullets"> <p>Thermo Fisher Scientific’s pharma services offering has an integrated global network of manufacturing sites that includes regulatory, technical, quality, Qualified Person (QP), and customer engagement teams that can support and solve complex challenges at every stage of your molecule’s lifecycle.</p> <p class="p-claim">Our proven track record and unparalleled expertise empowers the industry’s top biopharma companies to feel confident partnering with us.</p> <p>Our strong and diverse regulatory expertise, based on solid knowledge of the requirements of major entities (ICH/EMA/FDA) and a commitment to staying abreast of new regulatory trends, is the foundation that enables us to deliver exceptional services continuously recognized by our customers.</p> </div> </div> <div class="cmp-well aem-GridColumn aem-GridColumn--default--12"> <div class="well " id="well-1471805049"> <div class="container-fluid container-lg "> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> </div> </div> </div> <style type="text/css"> #well-1471805049 { border-radius: 0px; } </style> </div> <div class="text aem-GridColumn--offset--medium--0 aem-GridColumn--medium--none aem-GridColumn aem-GridColumn--default--12"> <div id="text-4f85975a89" class="cmp-text list-style-bullets"> <h2><b>Regulatory affairs expertise</b></h2> </div> </div> <div class="text aem-GridColumn aem-GridColumn--default--12"> <div id="text-3091590652" class="cmp-text list-style-check"> <p>Our regulatory affairs function provides industry-leading guidance to customers regarding the chemical and biological molecules we help develop and manufacture, spanning the product lifecycle from development through clinical and commercial. <span class="p-claim">To date, we have supported regulatory submissions in approximately 150 countries.</span></p> <p>Delivering professional support regarding regulatory affairs requirements and procedures, including:</p> <ul> <li>Independent and trustworthy advice on the best regulatory strategy</li> <li>Guidance through every step of the drug lifecycle, including:<ul> <li>Clinical applications. For example, preparation of Investigational New Drug (IND) applications and Investigational Medicinal Product Dossiers (IMPD)</li> <li>Pre-market applications. For example, preparation of Biological License Applications (BLA) and Marketing Authorization Applications (MAA)</li> <li>Post-market applications. For example, preparation of Post-Approval Supplements (PAS) and variations</li> </ul> </li> </ul> <p>Navigating a complex regulatory environment is vital to the success of your molecule’s lifecycle. Our industry-leading experience with regulatory bodies worldwide and close collaboration with your drug development, scale-up, and technology transfer teams empowers us to help get your medicine to market faster.</p> </div> </div> </div> </div> <style type="text/css"> #container-813483950{ background-image: url(''); background-color: ; background-size: cover; background-position: center; min-height: px; } #container-813483950 { border-radius: px; } </style> </div> </div> </div> </div> <style type="text/css"> #well-1067269820 { border-radius: 0px; } </style> </div> <div class="cmp-container aem-GridColumn aem-GridColumn--default--12"> <div class="cmp-container-inner " id="container-1492747908"> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> <div class="cmp-well aem-GridColumn aem-GridColumn--default--12"> <div class="well " id="well-682379125"> <div class="container-fluid container-lg "> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> <div class="text aem-GridColumn aem-GridColumn--default--12"> <div id="text-0fa3d8c0f5" class="cmp-text list-style-bullets"> <h4>Helpful Resources</h4> </div> </div> <div class="cmp-container aem-GridColumn aem-GridColumn--default--12"> <div class="cmp-container-inner " id="container-1385209365"> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> <div class="cmp-well aem-GridColumn aem-GridColumn--default--12"> <div class="well " id="well-1921339098"> <div class="container-fluid container-lg "> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 aem-Grid--xsmall--12 "> <div class="cmp-carousel aem-GridColumn--offset--xsmall--0 aem-GridColumn--xsmall--12 aem-GridColumn--xsmall--none aem-GridColumn aem-GridColumn--default--12"> <link rel="stylesheet" href="/etc.clientlibs/multisitecommons/clientlibs/vendor/slick_carousel.min.css" type="text/css"> <script src="/etc.clientlibs/multisitecommons/clientlibs/vendor/slick_carousel.min.js"></script> <div class="container-fluid container-md ps-0 pe-0"> <div class="carouselWrapper" data-arrowpos="sides" data-disableautoplay="true" data-objs="[{ "breakpoint": 594, "settings": { "speed": 2000, "slidesToShow": 1, "slidesToScroll": 1, "arrows": true, "infinite": true, "dots": false, "centerMode": true}}]" data-numslides="4" data-flex="false" id="carousel-981985379"> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 aem-Grid--medium--12 "> <div class="cmp-container aem-GridColumn--offset--medium--0 aem-GridColumn--offset--xsmall--0 aem-GridColumn--default--none aem-GridColumn--medium--newline aem-GridColumn--xsmall--newline aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--default--3 aem-GridColumn--offset--default--0"> <div class="cmp-container-inner me-3 " id="container-431733263"> <div class="aem-Grid aem-Grid--3 aem-Grid--default--3 aem-Grid--xsmall--3 aem-Grid--medium--3 "> <div class="cmp-library-card aem-GridColumn--offset--xsmall--0 aem-GridColumn--medium--3 aem-GridColumn--default--none aem-GridColumn--xsmall--3 aem-GridColumn--xsmall--newline aem-GridColumn aem-GridColumn--default--3 aem-GridColumn--offset--default--0"> <div class="library-card imgType-top" id="library_card-1956584882"> <div class="img-and-tag"> <img class="library-card-top-img" src="/content/dam/temp_patheon/library/thumbnails/generic/GenericI.png" alt=""/> <div class="upper-right-tag"> <i class="fak fa-patheon-factsheet pad-right icon"></i> Fact Sheet </div> </div> <div class="library-card-body"> <p class="library-card-preheader"> Fact Sheet </p> <p class="library-card-title"> Global regulatory services backed by industry experts </p> <span class="library-card-desc"> <p>Navigating a complex regulatory environment is vital to the success of your product’s lifecycle. Thermo Fisher Scientific provides a range of flexible regulatory solutions that can help easily address your molecule’s unique needs and challenges, while being backed by a global network and seasoned regulatory experts.</p> <p><a> </a></p> </span> <a href="https://www.patheon.com/us/en/insights-resources/fact-sheets/menu-for-global-regulatory-services-backed-by-industry-experts.html" target="_self" class="btn library-card-btn library-card-primary-btn "> View Fact Sheet </a> </div> </div> </div> </div> </div> <style type="text/css"> #container-431733263{ background-image: url(''); background-color: ; background-size: cover; background-position: center; min-height: px; } #container-431733263 { border-radius: px; } </style> </div> <div class="cmp-container aem-GridColumn--offset--medium--0 aem-GridColumn--offset--xsmall--0 aem-GridColumn--default--none aem-GridColumn--medium--newline aem-GridColumn--xsmall--newline aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--default--3 aem-GridColumn--offset--default--0"> <div class="cmp-container-inner me-3 " id="container-1284246306"> <div class="aem-Grid aem-Grid--3 aem-Grid--default--3 aem-Grid--xsmall--3 aem-Grid--medium--3 "> <div class="cmp-library-card aem-GridColumn--medium--3 aem-GridColumn--default--none aem-GridColumn--xsmall--3 aem-GridColumn aem-GridColumn--default--3 aem-GridColumn--offset--default--0"> <div class="library-card imgType-top" id="library_card-1141924735"> <div class="img-and-tag"> <img class="library-card-top-img" src="/content/dam/temp_patheon/library/thumbnails/oral-solid-dose/Oral_solid_doseH.png" alt=""/> <div class="upper-right-tag"> <i class="fak fa-patheon-brochure pad-right icon"></i> Brochure </div> </div> <div class="library-card-body"> <p class="library-card-preheader"> Brochure </p> <p class="library-card-title"> Developing a CMC and regulatory roadmap for your molecule’s lifecycle </p> <span class="library-card-desc"> <p>Getting your strategy right from the start of your molecule’s journey can help save time and money as you advance through each phase and proceed to commercialization.</p> <ol> </ol> </span> <a href="https://www.patheon.com/us/en/insights-resources/brochures/developing-a-cmc-and-regulatory-roadmap-for-your-molecules-lifecycle.html" target="_self" class="btn library-card-btn library-card-primary-btn "> View Brochure </a> </div> </div> </div> </div> </div> <style type="text/css"> #container-1284246306{ background-image: url(''); 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