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class="aem-GridColumn aem-GridColumn--default--5 aem-GridColumn--phone--12 hero-content"> <div class="copy-area"> <p><span class="eyebrow">Increase your probability of success and reveal new efficiencies</span></p> <h1>Regulatory Strategy Consulting</h1> </div> </div> <div class="aem-GridColumn aem-GridColumn--default--7 aem-GridColumn--phone--12 hero-pill"> <div class="image-container pill-right gassy"> <span class="gas"></span> <img src="/content/dam/fortrea/hero/GettyImages-536741082.jpg" alt title="536741082"/> </div> </div> </div> </div> <div class="aem_breadcrumb margin-bottom-50 aem-GridColumn aem-GridColumn--default--12"><!-- /* Optional styles to apply by author, with prefix "breadcrumb-" black */--> <nav aria-label="breadcrumb" class="breadcrumb" itemscope="" itemtype="http://schema.org/BreadcrumbList" data-cmp-data-layer="{&#34;breadcrumb-ffde12239b&#34;:{&#34;@type&#34;:&#34;fortrea/components/breadcrumb&#34;,&#34;repo:modifyDate&#34;:&#34;2023-09-22T16:40:44Z&#34;}}"> 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itemprop="position" content="4"/> </span> </nav> </div> <div class="aem_value-props aem-GridColumn aem-GridColumn--default--12"> <div class="value-props flex_grid flex_3x"> <div class="flex_item"> <div class="inset"> <i class="fas fa-check-circle fa-2x"></i> <p>Develop a regulatory strategy that helps you proactively navigate product development complexities. </p> </div> </div> <div class="flex_item"> <div class="inset"> <i class="fas fa-check-circle fa-2x"></i> <p>Get customized support to make the most of your meetings with regulatory agencies around the world. </p> </div> </div> <div class="flex_item"> <div class="inset"> <i class="fas fa-check-circle fa-2x"></i> <p>Access a wealth of experience to support your regulatory goals across each phase of development. </p> </div> </div> </div> </div> <div class="aem_text margin-none aem-GridColumn aem-GridColumn--default--12"> <link rel="stylesheet" href="/etc.clientlibs/fortrea/components/text-v2/clientlibs.min.css" type="text/css"> <div class="text"> <div class="text-body"><h2>Find the most appropriate regulatory path for your product.</h2> <p>Comprehensive planning significantly reduces the potential for regulatory-related delays by outlining your timeline alongside your nonclinical, CMC and clinical requirements. </p> <p>Even if you are planning to out-license or co-develop your product after proof of concept (PoC), our regulatory strategy consultants can help you look ahead to navigate several regulatory processes and programs, outline your expectations as well as help you address any issues, such as a clinical hold, to keep your program moving forward.<br /> </p> <p>Working side-by-side with our market access consulting and HEOR experts to ensure an optimal integrated stakeholder strategy, we offer vast experience implementing regulatory solutions spanning the spectrum of product development—from nonclinical to post-approval. We stay on the cutting edge of regulatory guidance and policies, in areas such as real-world evidence, digital health and software as a medical device (SaMD) as we support your regulatory goals at each phase and help you advance toward your commercial goals. </p> </div> </div> </div> <div class="html aem-GridColumn aem-GridColumn--default--12"> <style> .text-container-alternate-bg .fortrea_text-item p { font-size: 16px; } .text-container-alternate-bg .fortrea_text-item p b { font-size: 21px; font-family: 'GT Ultra Median'; font-weight: 300; color: #017e25; } .text-container-alternate-bg .fortrea_text-item p + p { Margin-top: 1rem; } </style> </div> <div class="text-container aem-GridColumn aem-GridColumn--default--12"> <div class="text-container-alternate-bg 3columntc"> <div class="fortrea_text-item"> <div class="fortrea_text_container_content"> <div class="fortrea_text-item-heading">Nonclinical regulatory strategy</div> <div class="fortrea_text-item-description"><p>Get scientific review of your data and subsequent guidance as we coordinate nonclinical laboratory testing with your selected vendor.  <br /> </p> </div></div> </div> <div class="fortrea_text-item"> <div class="fortrea_text_container_content"> <div class="fortrea_text-item-heading">CMC regulatory strategy</div> <div class="fortrea_text-item-description"><p>We can help develop your CMC plans, review data and provide writing services to support CMC submission documents.<br /> </p> </div></div> </div> <div class="fortrea_text-item"> <div class="fortrea_text_container_content"> <div class="fortrea_text-item-heading">Clinical regulatory strategy</div> <div class="fortrea_text-item-description"><p>Count on our team to prepare your clinical development plan, provide strategic input for your clinical protocol designs and support the development of your expedited program applications. <br /> </p> </div></div> </div> </div> </div> <div class="aem_text aem-GridColumn aem-GridColumn--default--12"> <div class="text"> <div class="text-body"><h2>Improve your interactions with Health Regulatory Agencies worldwide.</h2> <p>Make the most of your interactions with Health Regulatory Agencies (HRAs) with our team as your guide. We lead an average of 40-50 agency meetings worldwide each year—supporting products across all phases of development—and spanning many different objectives and needs. Our experience spans:</p> <ul> <li>United States and Canada: U.S. Food and Drug Administration (FDA); Health Canada</li> <li>European Union: European Medicines Agency (EMA); Committee for Orphan Medicinal Products (COMP); Paediatric Committee (PDCO)</li> <li>United Kingdom: Medicines and Healthcare products Regulatory Agency (MHRA) </li> <li>China: National Medical Products Administration (NMPA)</li> <li>Japan: Pharmaceuticals and Medical Devices Agency (PMDA); Ministry of Health, Labour and Welfare (MHLW)</li> </ul> <p> </p> <h2>Get support with specialized regulatory processes.</h2> <p>You can leverage our experience working directly with regulators to efficiently navigate the regulatory landscape.</p> <ul> <li>Submissions of Pediatric Plans, Diversity Plans, Fast Track, Breakthrough Therapy and RMAT designations in the US</li> <li>Expanded Access/Compassionate Use globally</li> <li>Orphan Designation in the US and the European Union</li> <li>SAKIGAKE designation in Japan</li> 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