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class="maybe-wrapper"> <div style="margin-left: auto; margin-right: auto;"> <h1 class="heading"> <span class="eyebrow ">Due Diligence Solutions</span> <span class="small has-lime-green-color">from</span><span class="large has-lime-green-color">thought</span><span class="small has-lighter-gray-color">to</span><span class="large has-lighter-gray-color">finish</span> </h1> </div> </div> </div> <div style="height:50px" aria-hidden="true" class="wp-block-spacer"></div> <h2 class="wp-block-heading is-style-no-margins has-dark-purple-color has-text-color has-sxlarge-font-size"><strong>Due Diligence</strong> Solutions</h2> <p class="has-splus-font-size">ELIQUENT understands the complex regulatory environment within which life sciences transactions take place. ELIQUENT regularly partners with investors to evaluate potential issues and regulatory risks that may be identified during life sciences transactions. Our team of experts provide investors with extensive research, regulatory history assessments, and recommendations on the path forward for potential deals that require regulatory risk analyses before and after decisions and transactions</p>  <div class=" my-[0px] copy" data-block="copy-block"> <div class=""> <p>ELIQUENT’s due diligence services are more than a compilation of public data – we go a step further by enabling the vast institutional knowledge of our regulatory experts to provide in-depth analyses tailored to our clients’ specific needs. ELIQUENT’s multidisciplinary team uses its extensive expertise to perform risk assessments that take into account business objectives, transaction timelines, and the industry and regulatory landscape. The result is an unbiased expert analysis of both expected and unexpected regulatory risks</p> </div> <div class="link-box"> <a class="copy-btn-link" href="https://eliquent.com/wp-content/uploads/2024/10/DUE-DILIGENCE-Info-Sheet-2024.11.01.pdf" target="_blank"> <svg class="copy-btn-icon" xmlns="http://www.w3.org/2000/svg" width="16" height="16" fill="currentColor" class="bi bi-download" viewBox="0 0 16 16"> <path d="M.5 9.9a.5.5 0 0 1 .5.5v3.1a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1v-3.1a.5.5 0 0 1 1 0v3.1a2 2 0 0 1-2 2h-12a2 2 0 0 1-2-2v-3.1a.5.5 0 0 1 .5-.5z" /> <path d="M5.354 7.854a.5.5 0 0 1 0-.708l2.5-2.5a.5.5 0 0 1 .707 0l2.5 2.5a.5.5 0 0 1-.707.708L8.5 6.207V11.5a.5.5 0 0 1-1 0V6.207L6.061 7.854a.5.5 0 0 1-.707 0z" /> </svg> INFO SHEET: Industry Due Diligence Solutions </a> </div> </div> <div style="height:50px" aria-hidden="true" class="wp-block-spacer"></div>  <div class="background-container-block alignfull is-style-no-margins has-lighter-gray-background-color"> <div class="maybe-wrapper"> <div class="acf-innerblocks-container"> <h2 class="wp-block-heading is-style-no-margins has-validant-blue-color has-text-color has-link-color has-sxlarge-font-size wp-elements-77bfc9e441b9eb103e2e6aa4def45ccf"><strong>Unlock </strong>Success</h2> <p class="is-style-default has-splus-font-size">ELIQUENT’s unique platform goes beyond traditional consulting to deliver <strong>full-service support</strong>. Our solutions address the entire product lifecycle with best-in-class insight and guidance that bridges the spectrum of regulatory challenges. </p> <p class="is-style-default has-splus-font-size">From the earliest phases of development, through regulatory submissions, to post-approval support, ELIQUENT’s robust blend of technical skill and clinical expertise guide companies <strong>to approval and beyond</strong>.</p> <div style="height:15px" aria-hidden="true" class="wp-block-spacer"></div> <div class="wp-block-columns is-style-no-margins is-layout-flex wp-container-core-columns-is-layout-1 wp-block-columns-is-layout-flex"> <div class="wp-block-column has-blue-background-color has-background is-layout-flow wp-block-column-is-layout-flow" style="flex-basis:45%"> <div style="height:10px" aria-hidden="true" class="wp-block-spacer"></div> </div> <div class="wp-block-column is-layout-flow wp-block-column-is-layout-flow" style="flex-basis:9%"></div> <div class="wp-block-column has-lime-green-background-color has-background is-layout-flow wp-block-column-is-layout-flow" style="flex-basis:46%"> <div style="height:10px" aria-hidden="true" class="wp-block-spacer"></div> </div> </div> <div class="wp-block-columns is-style-no-margins is-layout-flex wp-container-core-columns-is-layout-2 wp-block-columns-is-layout-flex"> <div class="wp-block-column is-layout-flow wp-block-column-is-layout-flow" style="flex-basis:45%"> <div style="height:10px" aria-hidden="true" class="wp-block-spacer"></div> <h2 class="wp-block-heading is-style-no-margins">Buy-Side Transactions</h2> <p class="is-style-no-margins">Our buy-side due diligence solutions empower investors with comprehensive insights to confidently navigate opportunities and achieve strategic objectives.</p> <div style="height:20px" aria-hidden="true" class="wp-block-spacer"></div> <h3 class="wp-block-heading is-style-no-margins">Scientific Rigor</h3> <p class="is-style-no-margins">With experience across the landscape of therapeutic areas and modalities, the ELIQUENT team provides the technical and scientific expertise investors need when considering a life sciences transaction. </p> <div style="height:20px" aria-hidden="true" class="wp-block-spacer"></div> <h3 class="wp-block-heading is-style-no-margins">Risk Mitigation</h3> <p class="is-style-no-margins">Investing in the life science arena comes with inherent risks. We go beyond identifying risks by providing strategic recommendations to mitigate them effectively, safeguarding your investments.</p> <div style="height:20px" aria-hidden="true" class="wp-block-spacer"></div> <h3 class="wp-block-heading is-style-no-margins">Market Intelligence</h3> <p class="is-style-no-margins">ELIQUENT’s industry knowledge and regulatory expertise offers invaluable market insights, enabling you to anticipate trends, assess competitive landscapes, and capitalize on emerging opportunities.</p> </div> <div class="wp-block-column is-layout-flow wp-block-column-is-layout-flow" style="flex-basis:10%"></div> <div class="wp-block-column is-layout-flow wp-block-column-is-layout-flow" style="flex-basis:45%"> <div style="height:10px" aria-hidden="true" class="wp-block-spacer"></div> <h2 class="wp-block-heading is-style-no-margins">Sell-Side Transactions</h2> <p class="is-style-no-margins">ELIQUENT provides clarity and an objective viewpoint, thereby maximizing value in a transaction, and empowering companies to make informed decisions.</p> <div style="height:20px" aria-hidden="true" class="wp-block-spacer"></div> <h3 class="wp-block-heading is-style-no-margins">Program Roadmap</h3> <p class="is-style-no-margins">ELIQUENT partners with companies to evaluate, prioritize, and optimize commercial assets and programs. By identifying areas for improvement and value enhancement, our team of experts create a roadmap to maximize the prospects for successful regulatory outcomes.</p> <div style="height:20px" aria-hidden="true" class="wp-block-spacer"></div> <h3 class="wp-block-heading is-style-no-margins">Risk Assessment</h3> <p class="is-style-no-margins">Our in-depth assessments go beyond identifying regulatory risks – the ELIQUENT team delivers strategic and technical recommendations for system-wide quality and regulatory enhancements.</p> <div style="height:20px" aria-hidden="true" class="wp-block-spacer"></div> <h3 class="wp-block-heading is-style-no-margins">Industry Insights</h3> <p class="is-style-no-margins">ELIQUENT provides companies with critical insights by monitoring and analyzing the life sciences sector for emerging trends, evolving regulatory reforms, and changes to the competitive landscape.</p> </div> </div> </div> </div> </div>  <div class="background-container-block alignfull is-style-no-margins has-dark-purple-background-color"> <div class="maybe-wrapper"> <div class="acf-innerblocks-container">  <div class="stats-slider-block is-style-default"> <div class="slides"> <div class="slide"><p><strong>Supported</strong> more than <strong>160 </strong>diligence deals since 2019</p> </div><div class="slide"><p><strong>120+</strong> diligence projects focused on</p> <p><strong>drug</strong>, <strong>biologic</strong>, <strong>vaccine</strong>, or <strong>CGT</strong></p> </div><div class="slide"><p>Partnered on diligence engagements with <strong>25+</strong></p> <p>of the <strong>top </strong>healthcare private equity firms globally</p> </div><div class="slide"><p>Diligence support for over <strong>$11 billion</strong> in realized client investments</p> </div> </div> </div> </div> </div> </div>  <div class="background-container-block alignfull is-style-no-margins background-none"> <div class="maybe-wrapper"> <div class="acf-innerblocks-container"> <h2 class="wp-block-heading is-style-default has-dark-purple-color has-text-color has-link-color has-sxlarge-font-size wp-elements-44d4f6385cf5a74222419a1c030f0013"><strong>Unmatched</strong> Expertise</h2> <p class="is-style-default has-splus-font-size">Our unprecedented assembly of regulatory leaders, industry experts, and technical specialists set the standard for regulatory consulting excellence. With <strong>decades of experience</strong> in senior positions at the FDA, EMA, and throughout industry, ELIQUENT’s team of respected professionals brings unmatched expertise that companies need when <strong>working directly with the regulators</strong> and when navigating today’s evolving regulatory environment.</p>  <div class="featured-team alignfull"> <div class="team-cards"> <div class="copy"></div> <div class="featured-team-grid" data-columns="3"> <a href="https://eliquent.com/team/elizabeth-oestreich-2/"> <article class="team-member"> <div class="team-member-image"> <img fetchpriority="high" decoding="async" width="1022" height="1024" src="https://eliquent.com/wp-content/uploads/2023/12/OESTREICH_HEADSHOT-WEB-headshot-1022x1024.png" class="team-member-photo wp-post-image" alt="" srcset="https://eliquent.com/wp-content/uploads/2023/12/OESTREICH_HEADSHOT-WEB-headshot-1022x1024.png 1022w, https://eliquent.com/wp-content/uploads/2023/12/OESTREICH_HEADSHOT-WEB-headshot-300x300.png 300w, https://eliquent.com/wp-content/uploads/2023/12/OESTREICH_HEADSHOT-WEB-headshot-150x150.png 150w, https://eliquent.com/wp-content/uploads/2023/12/OESTREICH_HEADSHOT-WEB-headshot-768x769.png 768w, https://eliquent.com/wp-content/uploads/2023/12/OESTREICH_HEADSHOT-WEB-headshot-519x520.png 519w, https://eliquent.com/wp-content/uploads/2023/12/OESTREICH_HEADSHOT-WEB-headshot.png 1078w" sizes="(max-width: 1022px) 100vw, 1022px" /> </div> <div class="team-member-info"> <h2 class="team-member-name">Elizabeth Oestreich</h2> <p class="team-member-job-title">Quality & Compliance Practice</p> </div> </article> </a> <a href="https://eliquent.com/team/john-taylor/"> <article class="team-member"> <div class="team-member-image"> <img decoding="async" width="1024" height="1024" src="https://eliquent.com/wp-content/uploads/2023/12/TAYLOR_JOHN-WEB-headshot-1080.2-1024x1024.png" class="team-member-photo wp-post-image" alt="" srcset="https://eliquent.com/wp-content/uploads/2023/12/TAYLOR_JOHN-WEB-headshot-1080.2-1024x1024.png 1024w, https://eliquent.com/wp-content/uploads/2023/12/TAYLOR_JOHN-WEB-headshot-1080.2-300x300.png 300w, https://eliquent.com/wp-content/uploads/2023/12/TAYLOR_JOHN-WEB-headshot-1080.2-150x150.png 150w, https://eliquent.com/wp-content/uploads/2023/12/TAYLOR_JOHN-WEB-headshot-1080.2-768x768.png 768w, https://eliquent.com/wp-content/uploads/2023/12/TAYLOR_JOHN-WEB-headshot-1080.2-520x520.png 520w, https://eliquent.com/wp-content/uploads/2023/12/TAYLOR_JOHN-WEB-headshot-1080.2.png 1080w" sizes="(max-width: 1024px) 100vw, 1024px" /> </div> <div class="team-member-info"> <h2 class="team-member-name">John M. Taylor, Esq.</h2> <p class="team-member-job-title">Head of Quality & Compliance Practice</p> </div> </article> </a> <a href="https://eliquent.com/team/donald-d-ashley-jd/"> <article class="team-member"> <div class="team-member-image"> <img decoding="async" width="1024" height="1024" src="https://eliquent.com/wp-content/uploads/2024/01/ASHLEY_DON-WEB-headshot-1024x1024.png" class="team-member-photo wp-post-image" alt="" srcset="https://eliquent.com/wp-content/uploads/2024/01/ASHLEY_DON-WEB-headshot-1024x1024.png 1024w, https://eliquent.com/wp-content/uploads/2024/01/ASHLEY_DON-WEB-headshot-300x300.png 300w, https://eliquent.com/wp-content/uploads/2024/01/ASHLEY_DON-WEB-headshot-150x150.png 150w, https://eliquent.com/wp-content/uploads/2024/01/ASHLEY_DON-WEB-headshot-768x768.png 768w, https://eliquent.com/wp-content/uploads/2024/01/ASHLEY_DON-WEB-headshot-520x520.png 520w, https://eliquent.com/wp-content/uploads/2024/01/ASHLEY_DON-WEB-headshot.png 1080w" sizes="(max-width: 1024px) 100vw, 1024px" /> </div> <div class="team-member-info"> <h2 class="team-member-name">Donald D. Ashley, JD</h2> <p class="team-member-job-title">Quality & Compliance Practice</p> </div> </article> </a> <a href="https://eliquent.com/team/daniel-schultz-md-f-a-c-s/"> <article class="team-member"> <div class="team-member-image"> <img decoding="async" width="1024" height="1024" src="https://eliquent.com/wp-content/uploads/2023/12/SCHULTZ_DAN-WEB-headshot-1024x1024.png" class="team-member-photo wp-post-image" alt="" srcset="https://eliquent.com/wp-content/uploads/2023/12/SCHULTZ_DAN-WEB-headshot-1024x1024.png 1024w, https://eliquent.com/wp-content/uploads/2023/12/SCHULTZ_DAN-WEB-headshot-300x300.png 300w, https://eliquent.com/wp-content/uploads/2023/12/SCHULTZ_DAN-WEB-headshot-150x150.png 150w, https://eliquent.com/wp-content/uploads/2023/12/SCHULTZ_DAN-WEB-headshot-768x768.png 768w, https://eliquent.com/wp-content/uploads/2023/12/SCHULTZ_DAN-WEB-headshot-520x520.png 520w, https://eliquent.com/wp-content/uploads/2023/12/SCHULTZ_DAN-WEB-headshot.png 1080w" sizes="(max-width: 1024px) 100vw, 1024px" /> </div> <div class="team-member-info"> <h2 class="team-member-name">Daniel Schultz, MD, F.A.C.S.</h2> <p class="team-member-job-title">Regulatory Affairs Practice</p> </div> </article> </a> </div> </div> <a class="cta" href="https://eliquent.com/team/" target="">See Full Team</a></div> </div> </div> </div>  <div class="background-container-block alignfull is-style-no-margins has-lighter-gray-background-color"> <div class="maybe-wrapper"> <div class="acf-innerblocks-container"> <h2 class="wp-block-heading is-style-no-margins has-validant-blue-color has-text-color has-link-color has-sxlarge-font-size wp-elements-8a4fe1d24bf6521f5050603de862940e"><strong>Strategic & </strong> Technical Capabilities</h2> <p class="has-splus-font-size">As former regulators and industry leaders, our understanding of the product lifecycle is unrivaled. ELIQUENT’s highly specialized experts provide both strategic direction and technical support from the earliest phases of development to post-approval regulatory support.</p> <div style="height:30px" aria-hidden="true" class="wp-block-spacer"></div> <div class="wp-block-columns is-style-no-margins is-layout-flex wp-container-core-columns-is-layout-3 wp-block-columns-is-layout-flex"> <div class="wp-block-column is-layout-flow wp-block-column-is-layout-flow" style="flex-basis:50%"> <div class="wp-block-media-text is-stacked-on-mobile is-vertically-aligned-top" style="grid-template-columns:20% auto"><figure class="wp-block-media-text__media"><img decoding="async" width="150" height="150" src="https://eliquent.com/wp-content/uploads/2024/04/CIRCLE-Medical-Product-outline-150x150.png" alt="" class="wp-image-1014 size-thumbnail"/></figure><div class="wp-block-media-text__content"> <p class="is-style-no-margins" style="font-size:22px"><strong>Product </strong>Development</p> <p class="is-style-no-margins" style="font-size:16px">Evaluation of clinical development plans, including review of clinical and nonclinical data, FDA correspondence, safety reporting, and sponsor proposals for future clinical studies.</p> </div></div> </div> <div class="wp-block-column is-layout-flow wp-block-column-is-layout-flow" style="flex-basis:50%"> <div class="wp-block-media-text is-stacked-on-mobile is-vertically-aligned-top" style="grid-template-columns:20% auto"><figure class="wp-block-media-text__media"><img decoding="async" width="150" height="150" src="https://eliquent.com/wp-content/uploads/2024/04/CIRCLE-Reg.-Pathway-Eva-outlinel-150x150.png" alt="" class="wp-image-1019 size-thumbnail"/></figure><div class="wp-block-media-text__content"> <p class="is-style-no-margins" style="font-size:22px"><strong>Pathway</strong> Evaluation</p> <p class="is-style-no-margins" style="font-size:16px">Determine eligibility for special designation(s), including priority review, fast track, accelerated approval, breakthrough therapy designation, and regenerative medicine advanced therapy designation.</p> </div></div> </div> </div> <div style="height:30px" aria-hidden="true" class="wp-block-spacer"></div> <div class="wp-block-columns is-style-no-margins is-layout-flex wp-container-core-columns-is-layout-4 wp-block-columns-is-layout-flex"> <div class="wp-block-column is-layout-flow wp-block-column-is-layout-flow" style="flex-basis:50%"> <div class="wp-block-media-text is-stacked-on-mobile is-vertically-aligned-top" style="grid-template-columns:20% auto"><figure class="wp-block-media-text__media"><img decoding="async" width="150" height="150" src="https://eliquent.com/wp-content/uploads/2024/04/CIRCLE-Regulatory-Submissions-outline-150x150.png" alt="" class="wp-image-1015 size-thumbnail"/></figure><div class="wp-block-media-text__content"> <p class="is-style-no-margins" style="font-size:22px"><strong>Regulatory </strong>Submissions</p> <p class="is-style-no-margins" style="font-size:16px">Review of pending product submissions to assess completeness and approval prospects, including FDA information requests, mid and late-cycle meetings, advisory committee outcomes, labeling negotiations, and inspectional results.</p> </div></div> </div> <div class="wp-block-column is-layout-flow wp-block-column-is-layout-flow" style="flex-basis:50%"> <div class="wp-block-media-text is-stacked-on-mobile is-vertically-aligned-top" style="grid-template-columns:20% auto"><figure class="wp-block-media-text__media"><img decoding="async" width="150" height="150" src="https://eliquent.com/wp-content/uploads/2024/04/CIRCLE-Compliance-outline-150x150.png" alt="" class="wp-image-1020 size-thumbnail"/></figure><div class="wp-block-media-text__content"> <p class="is-style-no-margins" style="font-size:22px"><strong>Compliance </strong>Status</p> <p class="is-style-no-margins" style="font-size:16px">Analysis of target company’s FDA compliance and enforcement history, including a review of FDA correspondence relating to compliance matters and identification of outstanding or pending compliance and remediation actions.</p> </div></div> </div> </div> <div style="height:30px" aria-hidden="true" class="wp-block-spacer"></div> <div class="wp-block-columns is-style-no-margins is-layout-flex wp-container-core-columns-is-layout-5 wp-block-columns-is-layout-flex"> <div class="wp-block-column is-layout-flow wp-block-column-is-layout-flow" style="flex-basis:50%"> <div class="wp-block-media-text is-stacked-on-mobile is-vertically-aligned-top" style="grid-template-columns:20% auto"><figure class="wp-block-media-text__media"><img decoding="async" width="150" height="150" src="https://eliquent.com/wp-content/uploads/2024/04/CIRCLE-Distribution-outline-1-150x150.png" alt="" class="wp-image-1016 size-thumbnail"/></figure><div class="wp-block-media-text__content"> <p class="is-style-no-margins" style="font-size:22px"><strong>Distribution & </strong>Supply Chain</p> <p class="is-style-no-margins" style="font-size:16px">Assessment of import-export practices, supply chain audit reports, outsourcing arrangements, and distribution procedures.</p> </div></div> </div> <div class="wp-block-column is-layout-flow wp-block-column-is-layout-flow" style="flex-basis:50%"> <div class="wp-block-media-text is-stacked-on-mobile is-vertically-aligned-top" style="grid-template-columns:20% auto"><figure class="wp-block-media-text__media"><img decoding="async" width="150" height="150" src="https://eliquent.com/wp-content/uploads/2024/04/CIRCLE-Clinical-outline-150x150.png" alt="" class="wp-image-1021 size-thumbnail"/></figure><div class="wp-block-media-text__content"> <p class="is-style-no-margins" style="font-size:22px"><strong>Preclinical & Clinical </strong>Systems</p> <p class="is-style-no-margins" style="font-size:16px">Assessment of compliance with FDA current good laboratory practice (GLP) and good clinical practice (GCP) regulations. </p> </div></div> </div> </div> <div style="height:30px" aria-hidden="true" class="wp-block-spacer"></div> <div class="wp-block-columns is-style-no-margins is-layout-flex wp-container-core-columns-is-layout-6 wp-block-columns-is-layout-flex"> <div class="wp-block-column is-layout-flow wp-block-column-is-layout-flow" style="flex-basis:50%"> <div class="wp-block-media-text is-stacked-on-mobile is-vertically-aligned-top" style="grid-template-columns:20% auto"><figure class="wp-block-media-text__media"><img decoding="async" width="150" height="150" src="https://eliquent.com/wp-content/uploads/2024/04/CIRCLE-Reporting-Requirements-outline-150x150.png" alt="" class="wp-image-1017 size-thumbnail"/></figure><div class="wp-block-media-text__content"> <p class="is-style-no-margins" style="font-size:22px"><strong>Reporting </strong>Requirements</p> <p class="is-style-no-margins" style="font-size:16px">Confirm that the target company has complied with all requirements for registration, authorization, filing, and listing associated with approved products, including user fee payments and fulfillment of postmarket obligations. </p> </div></div> </div> <div class="wp-block-column is-layout-flow wp-block-column-is-layout-flow" style="flex-basis:50%"> <div class="wp-block-media-text is-stacked-on-mobile is-vertically-aligned-top" style="grid-template-columns:20% auto"><figure class="wp-block-media-text__media"><img decoding="async" width="150" height="150" src="https://eliquent.com/wp-content/uploads/2024/04/CIRCLE-Quality-Manufacturing-outline-150x150.png" alt="" class="wp-image-1022 size-thumbnail"/></figure><div class="wp-block-media-text__content"> <p class="is-style-no-margins" style="font-size:22px">Q<strong>uality </strong>Manufacturing</p> <p class="is-style-no-margins" style="font-size:16px">Evaluation of the target company’s compliance with FDA quality and manufacturing regulations related to inspections, standard operating procedures, quality assurance activities, and relevant contract manufacturers.</p> </div></div> </div> </div> <div style="height:30px" aria-hidden="true" class="wp-block-spacer"></div> <div class="wp-block-columns is-style-no-margins is-layout-flex wp-container-core-columns-is-layout-7 wp-block-columns-is-layout-flex"> <div class="wp-block-column is-layout-flow wp-block-column-is-layout-flow" style="flex-basis:50%"> <div class="wp-block-media-text is-stacked-on-mobile is-vertically-aligned-top" style="grid-template-columns:20% auto"><figure class="wp-block-media-text__media"><img decoding="async" width="150" height="150" src="https://eliquent.com/wp-content/uploads/2024/04/CIRCLE-Adverse-Event-outline-1-150x150.png" alt="" class="wp-image-1018 size-thumbnail"/></figure><div class="wp-block-media-text__content"> <p class="is-style-no-margins" style="font-size:22px"><strong>Adverse Event </strong>Reporting</p> <p class="is-style-no-margins" style="font-size:16px">Review of adverse event reports (AERs) and good manufacturing practice complaints to ensure that the target company has taken appropriate measures for review and investigation. </p> </div></div> </div> <div class="wp-block-column is-layout-flow wp-block-column-is-layout-flow" style="flex-basis:50%"> <div class="wp-block-media-text is-stacked-on-mobile is-vertically-aligned-top" style="grid-template-columns:20% auto"><figure class="wp-block-media-text__media"><img decoding="async" src="https://eliquent.com/wp-content/uploads/2024/06/CIRCLE-with-Shaddow-Medium-Blue-POSTMARKET.svg" alt="" class="wp-image-3555 size-thumbnail"/></figure><div class="wp-block-media-text__content"> <p class="is-style-no-margins" style="font-size:22px"><strong>Marketing & </strong>Promotion</p> <p class="is-style-no-margins" style="font-size:16px">Evaluation of promotional practices and marketing materials, including labeling claims, promotion of unapproved products or off-label uses, and related FDA correspondence or enforcement actions. </p> </div></div> </div> </div> </div> </div> </div>  <div class="banner-link is-style-no-margins alignfull "> <img decoding="async" class="bg-image" src="https://eliquent.com/wp-content/uploads/2024/06/Regulatory-image-1.jpg" alt=""> <img decoding="async" class="bg-image-mobile" src="https://eliquent.com/wp-content/uploads/2024/06/GettyImages-1150962749-1.jpg" alt=""> <div class="maybe-wrapper"> <div class="content-area-aligment"> <div class="content-area"> <div class="copy"><h2>Regulatory & Medical Writing Solutions</h2> <p class="copy"><strong>Experience the power of clarity</strong></p> <p class="copy">From streamlining regulatory approvals to enhancing market presence, our medical writing solutions support your regulatory objectives and strengthen your market position.</p> </div> <a class="cta" href="https://eliquent.com/wp-content/uploads/2024/10/REG-WRITING-Info-Sheet-2024.11.01.pdf" target="_blank">Learn More</a> </div> </div> </div> </div>  <div class="background-container-block alignfull is-style-no-margins background-none"> <div class="maybe-wrapper"> <div class="acf-innerblocks-container"> <h2 class="wp-block-heading is-style-default has-dark-purple-color has-text-color has-link-color has-sxlarge-font-size wp-elements-8402806101e578f34c9b6331c17d3c56"><strong>Global</strong> Solutions</h2> <p class="has-splus-font-size"><strong>Expertise beyond borders. </strong>ELIQUENT’S established and growing global presence spans the regulatory process and major markets. Our premier team of global regulatory experts support markets across the U.S., Europe, and Asia.</p>  <div class="global-solutions is-style-no-margins"> <h3 class="main-heading"></h3> <div class="globe-outer-container"> <a class="highlight-united-states"></a> <a class="highlight-europe"></a> <a class="highlight-asia"></a> <div class="globe-inner-container"> <img decoding="async" src="https://eliquent.com/wp-content/uploads/2024/06/Globe-1.svg" alt=""> </div> </div> <div class="united-states-content"> <div> <h3 class="content-heading united-states-heading">United States</h3> <div class="content-description"><p class="content-description">ELIQUENT is a leading Food & Drug Administration (FDA) regulatory consulting firm that provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies.<br /> Our experts have shaped the landscape of FDA regulatory policy and strategy for decades. We bring this unrivaled knowledge and unique insight to our work with clients every day.</p> </div> </div> <svg class="united-states-line" xmlns="http://www.w3.org/2000/svg" width="83" height="157" viewBox="0 0 83 157" fill="none"> <path d="M2 0.5V155H83" stroke="#7F3483" stroke-width="3" stroke-dasharray="6 6" /> </svg> </div> <div class="europe-content"> <svg class="europe-line" xmlns="http://www.w3.org/2000/svg" width="116" height="191" viewBox="0 0 116 191" fill="none"> <path d="M114 0L114 189L3.14663e-06 189" stroke="#005178" stroke-width="3" stroke-dasharray="6 6" /> </svg> <div> <h3 class="content-heading europe-heading">Europe</h3> <div class="content-description"><p class="content-description">The ELIQUENT team applies their deep and diverse knowledge of European regulations to keep clients in lock-step with evolving global standards. With decades of experience in the European market, our team understands the intricacies of the European Medicines Agency (EMA) and offers tailored solutions to ensure products meet and exceed the needs of our clients.</p> </div> </div> </div> <div class="asia-content"> <svg class="asia-line" xmlns="http://www.w3.org/2000/svg" width="116" height="122" viewBox="0 0 116 122" fill="none"> <path d="M114 0L114 120L-4.77154e-07 120" stroke="#48A24F" stroke-width="3" stroke-dasharray="6 6" /> </svg> <div> <h3 class="content-heading asia-heading">Asia</h3> <div class="content-description"><p class="content-description">ELIQUENT offers regionally specialized solutions for the innovators across Asia. Our comprehensive solutions include expert guidance to innovators seeking approval in Japan, the third-largest pharmaceutical market in the world. Explore ELIQUENT’s solutions for clients in Japan’s life sciences market.</p> <p class="content-description"><strong>Explore ELIQUENT Japan</strong> <span style="color: #339966"><a style="color: #339966" href="https://eliquent.com/wp-content/uploads/2024/10/REG-AFFAIRS-JAPAN-Info-Sheet-2024.11.01.pdf" target="_blank" rel="noopener"><strong>>></strong></a></span></p> </div> </div> </div> </div> </div> </div> </div>  <div class="background-container-block alignfull is-style-no-margins has-light-blue-background-color"> <div class="maybe-wrapper"> <div class="acf-innerblocks-container"> <h2 class="wp-block-heading is-style-no-margins has-validant-blue-color has-text-color has-link-color has-sxlarge-font-size wp-elements-1775f49b716f1deb50cf4185824de0d6"><strong>Focus </strong>Areas</h2> <div style="height:10px" aria-hidden="true" class="wp-block-spacer"></div> <p class="is-style-default has-splus-font-size">ELIQUENT’s foundation is built on experts with the foremost strategic and technical skill across markets, pathways, and global regulations. ELIQUENT’s specialized solutions showcase our collective capabilities and combined expertise. Together, we create a full-service model that equips clients with a premier regulatory resource.</p> <div style="height:20px" aria-hidden="true" class="wp-block-spacer"></div>  <div class="callout-grid-block is-style-no-margins hide-mobile-pagination callout-grid" data-columns="3"> <div class="callout expands no-image" data-index="0"> <div class="content-area"> <div class="colour-line has-magenta-background-color"> </div> <div class="inner"> <h3 class="heading no-image">Market Solutions</h3> <p class="copy no-image"><p>Guided by decades of regulatory and clinical experience, our premier team of life science experts have the specialized skills to assist clients across therapeutic areas, modalities and markets.</p> </p> <a class="cta no-image" href="https://eliquent.com/focus-areas-landing/#market-solutions" target="">Market Solutions <span aria-hidden="true">></span></a> </div> </div> </div> <div class="callout expands no-image" data-index="1"> <div class="content-area"> <div class="colour-line has-lime-green-background-color"> </div> <div class="inner"> <h3 class="heading no-image">Pathway Solutions</h3> <p class="copy no-image"><p>As former regulators and industry leaders, our understanding of the product lifecycle is unrivaled. Clients turn to our team for strategic direction and hands-on execution services that support the earliest phases of development to post-approval and beyond.</p> </p> <a class="cta no-image" href="https://eliquent.com/focus-areas-landing/#pathway-solutions" target="">Pathway Solutions <span aria-hidden="true">></span></a> </div> </div> </div> <div class="callout expands no-image" data-index="2"> <div class="content-area"> <div class="colour-line has-blue-background-color"> </div> <div class="inner"> <h3 class="heading no-image">Global Solutions</h3> <p class="copy no-image"><p>ELIQUENT’S established and growing global presence spans the regulatory process and major markets. Our premier team of global regulatory experts support markets across the U.S., Europe, and Asia.</p> </p> <a class="cta no-image" href="https://eliquent.com/focus-areas-landing/#global_solutions" target="">Global Solutions <span aria-hidden="true">></span></a> </div> </div> </div> <div class="pagination"> <svg class="pagination-circle" data-page="0" xmlns="http://www.w3.org/2000/svg" width="26" height="26" viewBox="0 0 26 26" fill="none"> <circle cx="12.8" cy="12.8" r="12.8" transform="rotate(-90 12.8 12.8)" fill="#3E3D3D" /> </svg> <svg class="pagination-circle" data-page="1" xmlns="http://www.w3.org/2000/svg" width="26" height="26" viewBox="0 0 26 26" fill="none"> <circle cx="12.8" cy="12.8" r="12.8" transform="rotate(-90 12.8 12.8)" fill="#BBBABA" /> </svg> </div> </div> <script> document.addEventListener("DOMContentLoaded", function() { const calloutGridBlock = document.querySelector(".callout-grid-block"); const noImageCallouts = document.querySelectorAll(".callout.no-image"); // Check if there are any .callout elements with the .no-image class if (noImageCallouts.length > 0 && calloutGridBlock) { // Remove row-gap when .no-image is detected calloutGridBlock.style.rowGap = "30px"; } }); </script> </div> </div> </div>  <div class="background-container-block alignfull is-style-no-margins has-lighter-gray-background-color"> <div class="maybe-wrapper"> <div class="acf-innerblocks-container"> <h2 class="wp-block-heading is-style-no-margins has-dark-purple-color has-text-color has-link-color has-sxlarge-font-size wp-elements-10630a1730f608f4a87692793c9f4978">Integrated Solutions. </h2> <h2 class="wp-block-heading is-style-no-margins has-dark-purple-color has-text-color has-link-color has-sxlarge-font-size wp-elements-57aa09ccb9fac95788c9c3e34a03ec92"><strong>Full-Service Support</strong></h2> <p class="is-style-more-margins has-splus-font-size">ELIQUENT’s unprecedented assembly of regulatory leaders, industry experts, and technical specialists collaborate seamlessly to provide a full-service engagement that delivers end-to-end support. No matter your pathway position, regulatory requirements, global market or therapeutic area – <strong>ELIQUENT’s integrated solutions align with your regulatory goals to unlock regulatory success.</strong></p> <div style="height:0px" aria-hidden="true" class="wp-block-spacer"></div>  <div class="progression-block is-style-default"> <div class="outer"> <div class="progs"> <div class="prog-wrap"><div class="prog"><div class="circle"></div><div class="inner1"><div class="inner2"><h3>Regulatory Affairs Solutions</h3></div></div></div></div><div class="prog-wrap"><div class="prog"><div class="circle"></div><div class="inner1"><div class="inner2"><h3>PV+ Postmarket Surveillance</h3></div></div></div></div><div class="prog-wrap"><div class="prog"><div class="circle"></div><div class="inner1"><div class="inner2"><h3>Quality & Compliance</h3></div></div></div></div><div class="prog-wrap"><div class="prog"><div class="circle"></div><div class="inner1"><div class="inner2"><h3>Remediation 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class="has-dark-purple-color has-text-color has-link-color wp-elements-7ad32abe6f064a89e03154b063fab5e3"></p> </div> <div class="wp-block-column is-vertically-aligned-bottom is-layout-flow wp-block-column-is-layout-flow"> <p>With an approach that includes both strategic direction and hands-on global support, ELIQUENT’s customized <strong>pharmacovigilance</strong> solutions empower companies to operate with confidence.</p> <div class="wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex"> <div class="wp-block-button"><a class="wp-block-button__link wp-element-button" href="https://eliquent.com/solution/pharmacovigilance/">Learn More</a></div> </div> <p class="has-medium-purple-color has-text-color has-link-color wp-elements-cc926274b05a0322fe289a8cb8190686"></p> </div> <div class="wp-block-column is-vertically-aligned-bottom is-layout-flow wp-block-column-is-layout-flow"> <p>Our team of highly specialized <strong>quality & compliance</strong> experts build customized 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class="background-container-block alignfull is-style-no-margins background-none"> <div class="maybe-wrapper"> <div class="acf-innerblocks-container"> <div class="wp-block-columns is-style-no-margins is-layout-flex wp-container-core-columns-is-layout-9 wp-block-columns-is-layout-flex"> <div class="wp-block-column is-layout-flow wp-block-column-is-layout-flow" style="flex-basis:66.66%"> <div style="height:50px" aria-hidden="true" class="wp-block-spacer"></div> <figure class="wp-block-image size-large"><img decoding="async" width="417" height="61" src="https://eliquent.com/wp-content/uploads/2024/06/iqcentral-1.svg" alt="" class="wp-image-1341"/></figure> </div> <div class="wp-block-column is-layout-flow wp-block-column-is-layout-flow" style="flex-basis:33.33%"></div> </div> <p class="has-splus-font-size"><strong>Your resource for regulatory clarity.</strong></p> <p>IQ Central is your resource for industry insights, expert perspectives, and valuable tools. Here, you’ll find a comprehensive collection of collateral, expert resources, and thought leadership designed to support your goals and keep you informed on the latest trends and help you navigate today’s regulatory landscape.</p>  <div class="resource-icons-block resource-icons-grid" data-columns="3"> <div class="resource-icons expands" data-index="0"> <div class="content-area"> <h3 class="heading-main heading">RESOURCES</h3> <div class="inner"> <img decoding="async" src="https://eliquent.com/wp-content/uploads/2024/10/RESOURCE-Icon-info-sheet.png" alt=""> <div> <h3 class="heading">Information Sheet</h3> <p><p>ELIQUENT’s Industry Due Diligence Solutions</p> </p> <a class="cta" href="https://eliquentstg.wpenginepowered.com/wp-content/uploads/2024/10/DUE-DILIGENCE-Info-Sheet-2024.11.01.pdf" target="_blank">Download Info Sheet <span aria-hidden="true">></span></a> </div> </div> <div class=" inner" id="bottom-inner"> <img decoding="async" src="https://eliquent.com/wp-content/uploads/2024/10/RESOURCE-Icon-info-sheet.png" alt=""> <div> <h3 class="heading">Information Sheet</h3> <p><p>ELIQUENT’s Integrated Solutions for Full-Service Support</p> </p> <a class="cta" href="https://eliquentstg.wpenginepowered.com/wp-content/uploads/2024/10/FULL-SERVICE-Info-Sheet-P2-2024.11.01-1.svg" target="_blank">Download Info Sheet <span aria-hidden="true">></span></a> </div> </div> </div> </div> <div class="resource-icons expands" data-index="1"> <div class="content-area"> <h3 class="heading-main heading">THOUGHT LEADERSHIP</h3> <div class="inner"> <img decoding="async" src="https://eliquent.com/wp-content/uploads/2024/10/RESOURCE-Icon-white-paper.png" alt=""> <div> <h3 class="heading">Impact of R&D Quality Systems & Data Integrity in Drug Development</h3> <p><p>Read Steven Bowen, Ph.D.’s article in the <em>Journal of Pharmaceutical Sciences.</em></p> </p> <a class="cta" href="/" target="">Read more <span aria-hidden="true">></span></a> 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src="https://eliquent.com/wp-content/uploads/2024/10/RESOURCE-Icon-lightbulb.svg" alt=""> <div> <h3 class="heading">QMSR</h3> <p><p>Explore ELIQUENT’s Quality Management System Regulation (QMSR) Solutions.</p> </p> <a class="cta" href="/" target="">QMSR Solutions <span aria-hidden="true">></span></a> </div> </div> </div> </div> </div>  <div class="featured-resources-with-heading-block is-style-default"> <div class="resource-articles"> <h3 class="related-heading"></h3> <div class="resources-grid four-col"> <article id="post-1428" class="featured-resource-with-heading post-1428 resource type-resource status-publish has-post-thumbnail hentry resource_type-news-release"> <a href="https://eliquent.com/resource/new-post-iq-central-case-study-detail/" style="background-image:url(https://eliquent.com/wp-content/uploads/2024/11/BLOCK-with-overlay21.svg);"> <div class="post-type">resource</div> <p>IQ Central</p> <h3>ELIQUENT Launches Industry Due Diligence Solutions</h3> </a> </article> <article id="post-3842" class="featured-resource-with-heading post-3842 resource type-resource status-publish has-post-thumbnail hentry resource_type-case-study"> <a href="https://eliquent.com/resource/eliquent-outcomes-global-medical-device-firm-acquisition/" style="background-image:url(https://eliquent.com/wp-content/uploads/2024/11/BLOCK-with-overlay4.svg);"> <div class="post-type">resource</div> <p>IQ Central</p> <h3>ELIQUENT Outcomes: Global Medical Device Firm Acquisition</h3> </a> </article> <article id="post-3846" class="featured-resource-with-heading post-3846 resource type-resource status-publish has-post-thumbnail hentry resource_type-case-study"> <a href="https://eliquent.com/resource/eliquent-outcomes-private-equity-diligence-of-multiple-excipient-manufacturing/" style="background-image:url(https://eliquent.com/wp-content/uploads/2024/11/BLOCK-with-overlay17.svg);"> <div class="post-type">resource</div> <p>IQ Central</p> <h3>ELIQUENT Outcomes: Private Equity Diligence of Multiple Excipient Manufacturing</h3> </a> </article> <article id="post-3844" class="featured-resource-with-heading post-3844 resource type-resource status-publish has-post-thumbnail hentry resource_type-case-study"> <a href="https://eliquent.com/resource/eliquent-outcomes-sell-side-assessment-of-vaccine-manufacturer/" style="background-image:url(https://eliquent.com/wp-content/uploads/2024/11/BLOCK-with-overlay3.svg);"> <div class="post-type">resource</div> <p>IQ Central</p> <h3>ELIQUENT Outcomes: Sell-Side Assessment of Vaccine Manufacturer</h3> </a> </article> </div> </div> </div> </div> </div> </div>  <div class="background-container-block alignfull is-style-no-margins background-none"> <div class="maybe-wrapper"> <div class="acf-innerblocks-container"> <h2 class="wp-block-heading has-text-align-center is-style-no-margins has-dark-purple-color has-text-color">Ready for regulatory clarity? 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'<span class="ninja-forms-req-symbol">*</span>' : '' }}} {{{ data.maybeRenderHelp() }}} </span> <# } else { #> <label for="nf-field-{{{ data.id }}}" id="nf-label-field-{{{ data.id }}}" class="{{{ data.renderLabelClasses() }}}"> {{{ ( data.maybeFilterHTML() === 'true' ) ? _.escape( data.label ) : data.label }}} {{{ ( 'undefined' != typeof data.required && 1 == data.required ) ? '<span class="ninja-forms-req-symbol">*</span>' : '' }}} {{{ data.maybeRenderHelp() }}} </label> <# } #> </div> </script><script id="tmpl-nf-field-error" type="text/template"> <div class="nf-error-msg nf-error-{{{ data.id }}}" aria-live="assertive">{{{ data.msg }}}</div> </script><script id="tmpl-nf-form-error" type="text/template"> <div class="nf-error-msg nf-error-{{{ data.id }}}">{{{ data.msg }}}</div> </script><script id="tmpl-nf-field-input-limit" type="text/template"> {{{ data.currentCount() }}} {{{ nfi18n.of }}} {{{ data.input_limit }}} {{{ data.input_limit_msg }}} </script><script id="tmpl-nf-field-null" type="text/template"> </script><script id="tmpl-nf-field-textbox" type="text/template"> <input type="text" value="{{{ _.escape( data.value ) }}}" class="{{{ data.renderClasses() }}} nf-element" {{{ data.renderPlaceholder() }}} {{{ data.maybeDisabled() }}} {{{ data.maybeInputLimit() }}} id="nf-field-{{{ data.id }}}" name="{{ data.custom_name_attribute || 'nf-field-' + data.id + '-' + data.type }}" {{{ data.maybeDisableAutocomplete() }}} aria-invalid="false" aria-describedby="nf-error-{{{ data.id }}} nf-description-{{{ data.id }}}" aria-labelledby="nf-label-field-{{{ data.id }}}" {{{ data.maybeRequired() }}} > </script> <script id='tmpl-nf-field-input' type='text/template'> <input id="nf-field-{{{ data.id }}}" name="nf-field-{{{ data.id }}}" aria-invalid="false" aria-describedby="nf-error-{{{ data.id }}} nf-description-{{{ data.id }}}" class="{{{ data.renderClasses() }}} nf-element" type="text" value="{{{ _.escape( data.value ) }}}" {{{ data.renderPlaceholder() }}} {{{ data.maybeDisabled() }}} aria-labelledby="nf-label-field-{{{ data.id }}}" {{{ data.maybeRequired() }}} > </script> <script id="tmpl-nf-field-email" type="text/template"> <input type="email" value="{{{ _.escape( data.value ) }}}" class="{{{ data.renderClasses() }}} nf-element" id="nf-field-{{{ data.id }}}" name="{{ data.custom_name_attribute || 'nf-field-' + data.id + '-' + data.type }}" {{{data.maybeDisableAutocomplete()}}} {{{ data.renderPlaceholder() }}} {{{ data.maybeDisabled() }}} aria-invalid="false" aria-describedby="nf-error-{{{ data.id }}} nf-description-{{{ data.id }}}" aria-labelledby="nf-label-field-{{{ data.id }}}" {{{ data.maybeRequired() }}} > </script> <script id="tmpl-nf-field-textarea" type="text/template"> <textarea id="nf-field-{{{ data.id }}}" name="nf-field-{{{ data.id }}}" aria-invalid="false" aria-describedby="nf-error-{{{ data.id }}} nf-description-{{{ data.id }}}" class="{{{ data.renderClasses() }}} nf-element" {{{ data.renderPlaceholder() }}} {{{ data.maybeDisabled() }}} {{{ data.maybeDisableAutocomplete() }}} {{{ data.maybeInputLimit() }}} aria-labelledby="nf-label-field-{{{ data.id }}}" {{{ data.maybeRequired() }}} >{{{ _.escape( data.value ) }}}</textarea> </script>  <script id="tmpl-nf-rte-media-button" type="text/template"> <span class="dashicons dashicons-admin-media"></span> </script> <script id="tmpl-nf-rte-link-button" type="text/template"> <span class="dashicons dashicons-admin-links"></span> </script> <script id="tmpl-nf-rte-unlink-button" type="text/template"> <span class="dashicons dashicons-editor-unlink"></span> </script> <script id="tmpl-nf-rte-link-dropdown" type="text/template"> <div class="summernote-link"> URL <input type="url" class="widefat code link-url"> <br /> Text <input type="url" class="widefat code link-text"> <br /> <label> <input type="checkbox" class="link-new-window"> {{{ nfi18n.fieldsTextareaOpenNewWindow }}} </label> <input type="button" class="cancel-link extra" value="Cancel"> <input type="button" class="insert-link extra" value="Insert"> </div> </script> <script id="tmpl-nf-field-submit" type="text/template"> <# let myType = data.type if('save'== data.type){ myType = 'button' } #> <input id="nf-field-{{{ data.id }}}" class="{{{ data.renderClasses() }}} nf-element " type="{{{myType}}}" value="{{{ ( data.maybeFilterHTML() === 'true' ) ? _.escape( data.label ) : data.label }}}" {{{ ( data.disabled ) ? 'aria-disabled="true" disabled="true"' : '' }}}> </script><script id='tmpl-nf-field-button' type='text/template'> <button id="nf-field-{{{ data.id }}}" name="nf-field-{{{ data.id }}}" class="{{{ data.classes }}} nf-element"> {{{ ( data.maybeFilterHTML() === 'true' ) ? _.escape( data.label ) : data.label }}} </button> </script></body> </html>