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Regulatory Affairs - Eliquent

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margin-right: auto;"> <h1 class="heading"> <span class="eyebrow ">Regulatory clarity</span> <span class="small ">from</span><span class="large ">thought</span><span class="small has-lime-green-color">to</span><span class="large has-lime-green-color">finish</span> </h1> </div> </div> </div> <div style="height:30px" aria-hidden="true" class="wp-block-spacer"></div> <h2 class="wp-block-heading is-style-default has-dark-purple-color has-text-color has-sxlarge-font-size"><strong><strong>Regulatory Affairs </strong></strong>Solutions</h2> <h4 class="wp-block-heading has-splus-font-size"><strong>To approval and beyond.</strong></h4> <!-- BLOCK: COPY --> <div class=" my-[0px] copy" data-block="copy-block"> <div class=""> <p>In the complex life sciences landscape, where innovation meets regulation, a trusted regulatory partner is paramount.</p> <p>ELIQUENT is the singular regulatory resource that clients around the world trust. Our unique platform goes beyond traditional consulting to deliver end-to-end solutions. ELIQUENT is more than a service provider—we are your strategic partner in regulatory success.</p> <p>With a deep understanding of the regulatory landscape, we work as an extension of your team, offering proactive solutions that streamline your path to approval and beyond. Our premier team of regulatory experts have served in senior positions at global regulatory authorities and throughout industry. This rare blend of perspectives developed as leaders in both the public and private sectors enables us to deliver valuable insight throughout the product lifecycle.</p> <p>No matter your pathway position, regulatory requirements, global market or therapeutic area – ELIQUENT’s integrated solutions align with your regulatory goals to unlock success.</p> </div> <div class="link-box"> <a class="copy-btn-link" href="https://eliquent.com/wp-content/uploads/2024/10/REG-AFFAIRS-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: Regulatory Affairs Solutions </a> </div> </div> <div style="height:30px" aria-hidden="true" class="wp-block-spacer"></div> <!-- Block: background-container --> <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-65106e92b80f74f359f6148cccf5abad"><strong>Strategic &amp; Technical </strong>Capabilities </h2> <p class="is-style-default has-splus-font-size">Guided by decades of regulatory and clinical experience, and firmly grounded in the principles of public health, ELIQUENT’s team of regulatory experts is unmatched.</p> <p class="is-style-default has-splus-font-size">Clients count on us to provide objective advice and valuable insight throughout the product lifecycle. As former regulators and industry leaders, our understanding of the product lifecycle is unrivaled. ELIQUENT’s highly specialized experts provide both strategic direction and hands-on execution services to to support clients 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-1 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:26% auto"><figure class="wp-block-media-text__media"><img decoding="async" src="https://eliquent.com/wp-content/uploads/2024/10/ICON-Venn-Md-Blue.svg" alt="" class="wp-image-3159 size-thumbnail"/></figure><div class="wp-block-media-text__content"> <p class="is-style-no-margins" style="font-size:22px"><strong>Pipeline Review</strong> &amp; Optimization</p> <p class="is-style-no-margins" style="font-size:16px">Our team of regulatory experts evaluate and prioritize development pipelines to identify valuable portfolio opportunities and to understand and effectively manage regulatory risks.</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:26% auto"><figure class="wp-block-media-text__media"><img decoding="async" src="https://eliquent.com/wp-content/uploads/2024/10/ICON-Gears-Green.svg" alt="" class="wp-image-3133 size-thumbnail"/></figure><div class="wp-block-media-text__content"> <p class="is-style-no-margins" style="font-size:22px"><strong>CMC </strong>Strategy</p> <p class="is-style-no-margins" style="font-size:16px">ELIQUENT’s highly experienced team of specialists strengthen CMC packages by facilitating risk-based evaluations that enable effective design and implementation strategies.</p> </div></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:50%"> <div class="wp-block-media-text is-stacked-on-mobile is-vertically-aligned-top" style="grid-template-columns:26% auto"><figure class="wp-block-media-text__media"><img decoding="async" src="https://eliquent.com/wp-content/uploads/2024/10/ICON-BLANK-Pre-Non-CLINICAL-copy.svg" alt="" class="wp-image-3146 size-thumbnail"/></figure><div class="wp-block-media-text__content"> <p class="is-style-no-margins" style="font-size:22px"><strong>Clinical</strong> Programs</p> <p class="is-style-no-margins" style="font-size:16px">With decades of hands-on experience, ELIQUENT professionals provide best-in-class scientific and regulatory guidance on nonclinical, pre-clinical, and clinical programs across all therapeutic areas.</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:26% auto"><figure class="wp-block-media-text__media"><img decoding="async" src="https://eliquent.com/wp-content/uploads/2024/10/ICON-Policy-Plum-.svg" alt="" class="wp-image-3100 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">ELIQUENT applies extensive regulatory perspective to develop and implement actionable strategies that optimize a product’s regulatory submission and enhance agency interactions.</p> </div></div> </div> </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:26% auto"><figure class="wp-block-media-text__media"><img decoding="async" src="https://eliquent.com/wp-content/uploads/2024/10/ICON-Path-Purple.svg" alt="" class="wp-image-3118 size-thumbnail"/></figure><div class="wp-block-media-text__content"> <p class="is-style-no-margins" style="font-size:22px"><strong>Pathway</strong> Solutions</p> <p class="is-style-no-margins" style="font-size:16px">ELIQUENT experts work with companies to develop comprehensive regulatory strategies that take into account special designation eligibility and the pathway selection for a successful result.</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:26% auto"><figure class="wp-block-media-text__media"><img decoding="async" src="https://eliquent.com/wp-content/uploads/2024/10/ICON-Megaphone-Md-Blue.svg" alt="" class="wp-image-3160 size-thumbnail"/></figure><div class="wp-block-media-text__content"> <p class="is-style-no-margins" style="font-size:22px"><strong>Marketing, Promotion</strong> &amp; Labeling</p> <p class="is-style-no-margins" style="font-size:16px">Our team of skilled advisors provide specialized support and strategic direction on labeling requirements, promotional materials, and marketing programs.promotional materials, and marketing programs</p> </div></div> </div> </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:26% auto"><figure class="wp-block-media-text__media"><img decoding="async" src="https://eliquent.com/wp-content/uploads/2024/10/ICON-Comms-Md-Blue.svg" alt="" class="wp-image-3051 size-thumbnail"/></figure><div class="wp-block-media-text__content"> <p class="is-style-no-margins" style="font-size:22px"><strong>Regulatory </strong>Communications</p> <p class="is-style-no-margins" style="font-size:16px">ELIQUENT’s team of respected professionals bring an unmatched level of credibility and trust when interacting with global regulators and guiding companies on the regulatory pathway.</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:26% auto"><figure class="wp-block-media-text__media"><img decoding="async" src="https://eliquent.com/wp-content/uploads/2024/10/ICON-TEST.svg" alt="" class="wp-image-3168 size-thumbnail"/></figure><div class="wp-block-media-text__content"> <p class="is-style-no-margins" style="font-size:22px"><strong>Lifecycle</strong> Support</p> <p class="is-style-no-margins" style="font-size:16px">ELIQUENT’s integrated solutions equip innovators with strategic insight and actionable strategies that span the product lifecycle and unlock regulatory success.</p> </div></div> </div> </div> </div> </div> </div> <!-- Block: background-container --> <div class="background-container-block alignfull is-style-no-margins has-validant-blue-background-color"> <div class="maybe-wrapper"> <div class="acf-innerblocks-container"> <!-- Block: stats-slider --> <div class="stats-slider-block"> <div class="slides"> <div class="slide"><p><strong>300+</strong> years of collective <strong>FDA</strong> experience</p> </div><div class="slide"><p>Over <strong>160 INDs</strong> submitted with a <strong>98%</strong> success rate.</p> </div><div class="slide"><p>Submitted over <strong>50</strong> applications for <strong>breakthrough</strong> <strong>therapies.</strong></p> </div> </div> </div> </div> </div> </div> <!-- Block: background-container --> <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-no-margins has-dark-purple-color has-text-color has-link-color has-sxlarge-font-size wp-elements-ba3d25ca02df322f08c18d81e4327cf2"><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> <!-- Block: featured-teams --> <div class="featured-team is-style-no-margins alignfull"> <div class="team-cards"> <div class="copy"></div> <div class="featured-team-grid" data-columns="3"> <a href="https://eliquent.com/team/michele-dougherty-ph-d/"> <article class="team-member"> <div class="team-member-image"> <img fetchpriority="high" decoding="async" width="1024" height="1024" src="https://eliquent.com/wp-content/uploads/2023/12/DOUGHERTY_MICHELE-WEB-headshot-FINAL-1080.2-1024x1024.png" class="team-member-photo wp-post-image" alt="" srcset="https://eliquent.com/wp-content/uploads/2023/12/DOUGHERTY_MICHELE-WEB-headshot-FINAL-1080.2-1024x1024.png 1024w, https://eliquent.com/wp-content/uploads/2023/12/DOUGHERTY_MICHELE-WEB-headshot-FINAL-1080.2-300x300.png 300w, https://eliquent.com/wp-content/uploads/2023/12/DOUGHERTY_MICHELE-WEB-headshot-FINAL-1080.2-150x150.png 150w, https://eliquent.com/wp-content/uploads/2023/12/DOUGHERTY_MICHELE-WEB-headshot-FINAL-1080.2-768x768.png 768w, https://eliquent.com/wp-content/uploads/2023/12/DOUGHERTY_MICHELE-WEB-headshot-FINAL-1080.2-520x520.png 520w, https://eliquent.com/wp-content/uploads/2023/12/DOUGHERTY_MICHELE-WEB-headshot-FINAL-1080.2.png 1080w" sizes="(max-width: 1024px) 100vw, 1024px" /> </div> <div class="team-member-info"> <h2 class="team-member-name">Michele Dougherty, Ph.D.</h2> <p class="team-member-job-title">Head, Regulatory Affairs Practice</p> </div> </article> </a> <a href="https://eliquent.com/team/sandra-kweder-m-d/"> <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/KWEDER_SANDRA-WEB-headshot-1024x1024.png" class="team-member-photo wp-post-image" alt="" srcset="https://eliquent.com/wp-content/uploads/2024/01/KWEDER_SANDRA-WEB-headshot-1024x1024.png 1024w, https://eliquent.com/wp-content/uploads/2024/01/KWEDER_SANDRA-WEB-headshot-300x300.png 300w, https://eliquent.com/wp-content/uploads/2024/01/KWEDER_SANDRA-WEB-headshot-150x150.png 150w, https://eliquent.com/wp-content/uploads/2024/01/KWEDER_SANDRA-WEB-headshot-768x768.png 768w, https://eliquent.com/wp-content/uploads/2024/01/KWEDER_SANDRA-WEB-headshot-1536x1536.png 1536w, https://eliquent.com/wp-content/uploads/2024/01/KWEDER_SANDRA-WEB-headshot-2048x2048.png 2048w, https://eliquent.com/wp-content/uploads/2024/01/KWEDER_SANDRA-WEB-headshot-1900x1900.png 1900w, https://eliquent.com/wp-content/uploads/2024/01/KWEDER_SANDRA-WEB-headshot-520x520.png 520w" sizes="(max-width: 1024px) 100vw, 1024px" /> </div> <div class="team-member-info"> <h2 class="team-member-name">Sandra L. Kweder, M.D.</h2> <p class="team-member-job-title">Regulatory Affairs Practice</p> </div> </article> </a> <a href="https://eliquent.com/team/chris-leptak-m-d-ph-d/"> <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/LEPTAK_CHRIS-WEB-headshot-1024x1024.png" class="team-member-photo wp-post-image" alt="" srcset="https://eliquent.com/wp-content/uploads/2024/01/LEPTAK_CHRIS-WEB-headshot-1024x1024.png 1024w, https://eliquent.com/wp-content/uploads/2024/01/LEPTAK_CHRIS-WEB-headshot-300x300.png 300w, https://eliquent.com/wp-content/uploads/2024/01/LEPTAK_CHRIS-WEB-headshot-150x150.png 150w, https://eliquent.com/wp-content/uploads/2024/01/LEPTAK_CHRIS-WEB-headshot-768x768.png 768w, https://eliquent.com/wp-content/uploads/2024/01/LEPTAK_CHRIS-WEB-headshot-1536x1536.png 1536w, https://eliquent.com/wp-content/uploads/2024/01/LEPTAK_CHRIS-WEB-headshot-2048x2048.png 2048w, https://eliquent.com/wp-content/uploads/2024/01/LEPTAK_CHRIS-WEB-headshot-1900x1900.png 1900w, https://eliquent.com/wp-content/uploads/2024/01/LEPTAK_CHRIS-WEB-headshot-520x520.png 520w" sizes="(max-width: 1024px) 100vw, 1024px" /> </div> <div class="team-member-info"> <h2 class="team-member-name">Chris Leptak, M.D., Ph.D.</h2> <p class="team-member-job-title">Regulatory Affairs Practice</p> </div> </article> </a> <a href="https://eliquent.com/team/ifty-saiyed/"> <article class="team-member"> <div class="team-member-image"> <img decoding="async" width="1024" height="1024" src="https://eliquent.com/wp-content/uploads/2024/10/Ifty-Saiyed-square-1024x1024.jpg" class="team-member-photo wp-post-image" alt="" srcset="https://eliquent.com/wp-content/uploads/2024/10/Ifty-Saiyed-square-1024x1024.jpg 1024w, https://eliquent.com/wp-content/uploads/2024/10/Ifty-Saiyed-square-300x300.jpg 300w, https://eliquent.com/wp-content/uploads/2024/10/Ifty-Saiyed-square-150x150.jpg 150w, https://eliquent.com/wp-content/uploads/2024/10/Ifty-Saiyed-square-768x768.jpg 768w, https://eliquent.com/wp-content/uploads/2024/10/Ifty-Saiyed-square-520x520.jpg 520w, https://eliquent.com/wp-content/uploads/2024/10/Ifty-Saiyed-square.jpg 1134w" sizes="(max-width: 1024px) 100vw, 1024px" /> </div> <div class="team-member-info"> <h2 class="team-member-name">Ifty Saiyed</h2> <p class="team-member-job-title">Regulatory Affairs Practice &#8211; Europe</p> </div> </article> </a> </div> </div> <a class="cta" href="https://eliquent.com/team/" target="">See Full Team</a></div> </div> </div> </div> <!-- Block: background-container --> <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-f0b363d24123f2da0b42b859c2bc4b6a"><strong>Market</strong> Solutions</h2> <p class="has-splus-font-size">With a robust understanding of global regulatory requirements, ELIQUENT provides tailored solutions that support pharmaceutical, biotechnology, medical device, and combination product companies navigating the complex regulatory landscape. Our team of highly qualified experts bring decades of regulatory, quality, safety, and clinical experience in the following markets specialties:</p> <div class="wp-block-columns 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:48%"> <p class="is-style-no-margins has-validant-blue-color has-text-color has-link-color wp-elements-c2796a65b12f59285e0923eba4938e98" style="font-size:25px"><strong>Drugs &amp; Biological</strong> Products</p> <p class="is-style-no-margins" style="font-size:18px">ELIQUENT’s team of experts provide strategic and technical guidance on drugs and biologics from product development to regulatory review and beyond post-market requirements.</p> <!-- BLOCK: FAQ ACCORDION --> <div class="tablist accordion-version-two" data-block="faq-accordion-block" data-accordion-id="faq-accordion-67421104b3847"> <dl class=""> <div class="py-[32px] faq-border" style="background-color: #005178;"> <dt class="mb-[8px]"> <button type="button" style="background-color: #005178; --toggle-color: #FFF;" class="faq-toggle white-font #FFF" aria-controls="faq-accordion-67421104b3847-faq-0" aria-expanded="false"> <p>Areas of expertise</p> </button> </dt> <dd class="hidden faq-content black-font" style="background-color: #ffffff;" id="faq-accordion-67421104b3847-faq-0"> <p><strong>Areas of expertise:</strong></p> <p>Monoclonal Antibodies<br /> Enzyme Replacement Therapies<br /> Biosimilars<br /> Tissue-Based Therapies<br /> Vaccines</p> <p><strong>Learn more about ELIQUENT&#8217;s Drug &amp; Biological Product Solutions:</strong></p> <p>Drug &amp; Biological Product Solutions <a href="https://eliquent.com/wp-content/uploads/2024/10/DRUGS-Info-Sheet-2024.11.01.pdf" target="_blank" rel="noopener">&gt;&gt;</a></p> <p>INFO SHEET: Drug &amp; Biological Product Solutions <a href="https://eliquent.com/focus-area/drugs-biologics/">&gt;&gt;</a></p> </dd> </div> </dl> </div> <script> document.addEventListener('DOMContentLoaded', function() { // Initialize each accordion separately document.querySelectorAll('[data-block="faq-accordion-block"]').forEach(function(accordion) { const accordionId = accordion.dataset.accordionId; 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CGTs</p> <p class="is-style-no-margins" style="font-size:18px">Our team of regulatory and clinical experts apply their specialized skill-set to move complex therapies through the regulatory process to manufacturing and beyond.</p> <!-- BLOCK: FAQ ACCORDION --> <div class="tablist accordion-version-two" data-block="faq-accordion-block" data-accordion-id="faq-accordion-67421104b4964"> <dl class=""> <div class="py-[32px] faq-border" style="background-color: #7f3483;"> <dt class="mb-[8px]"> <button type="button" style="background-color: #7f3483; --toggle-color: #FFF;" class="faq-toggle white-font #FFF" aria-controls="faq-accordion-67421104b4964-faq-0" aria-expanded="false"> <p>Areas of expertise</p> </button> </dt> <dd class="hidden faq-content black-font" style="background-color: #ffffff;" id="faq-accordion-67421104b4964-faq-0"> <p><strong>Areas of Expertise:</strong></p> <p>Monoclonal Antibodies<br /> Enzyme Replacement Therapies<br /> Biosimilars<br /> Tissue-Based Therapies<br /> Vaccines</p> </dd> </div> </dl> </div> <script> document.addEventListener('DOMContentLoaded', function() { // Initialize each accordion separately document.querySelectorAll('[data-block="faq-accordion-block"]').forEach(function(accordion) { const accordionId = accordion.dataset.accordionId; const toggles = accordion.querySelectorAll('.faq-toggle'); let currentlyOpen = null; toggles.forEach(function(toggle) { toggle.addEventListener('click', function() { const contentId = this.getAttribute('aria-controls'); const content = document.getElementById(contentId); // If clicking the currently open toggle, close it if (this === currentlyOpen) { this.setAttribute('aria-expanded', 'false'); content.classList.add('hidden'); currentlyOpen = null; return; } // Close currently open item in this accordion if (currentlyOpen) { const openContentId = currentlyOpen.getAttribute('aria-controls'); const openContent = document.getElementById(openContentId); currentlyOpen.setAttribute('aria-expanded', 'false'); openContent.classList.add('hidden'); } // Open clicked item this.setAttribute('aria-expanded', 'true'); content.classList.remove('hidden'); currentlyOpen = this; }); }); }); }); </script></div> </div> <div class="wp-block-columns 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:48%"> <p class="is-style-no-margins has-dark-purple-color has-text-color has-link-color wp-elements-d27e14068e210ca3723613cf3538caf6" style="font-size:25px"><strong>Combination</strong> Products</p> <p class="is-style-no-margins" style="font-size:18px">Unlock the full potential of your combination product. Our team supports companies developing combination products with expert guidance throughout the product lifecycle.</p> <!-- BLOCK: FAQ ACCORDION --> <div class="tablist accordion-version-two" data-block="faq-accordion-block" data-accordion-id="faq-accordion-67421104b5838"> <dl class=""> <div class="py-[32px] faq-border" style="background-color: #483285;"> <dt class="mb-[8px]"> <button type="button" style="background-color: #483285; --toggle-color: #FFF;" class="faq-toggle white-font #FFF" aria-controls="faq-accordion-67421104b5838-faq-0" aria-expanded="false"> <p>Areas of expertise</p> </button> </dt> <dd class="hidden faq-content black-font" style="background-color: #ffffff;" id="faq-accordion-67421104b5838-faq-0"> <p><strong>Areas of Expertise:</strong></p> <p>Single-entity, co-packaged, and cross-labeled products</p> <p>Drug-coated devices</p> <p>Drug delivery systems</p> <p>Companion Diagnostics</p> <p><strong>Learn more about ELIQUENT&#8217;s Combination Product Product Solutions:</strong></p> <p>Combination Product Solutions <a href="https://eliquent.com/focus-area/combination-products/" target="_blank" rel="noopener">&gt;&gt;</a></p> <p>INFO SHEET: Combination Product Solutions <a href="https://eliquent.com/wp-content/uploads/2024/10/COMBO-PRODUCTS-Info-Sheet-2024.11.01.pdf" target="_blank" rel="noopener">&gt;&gt;</a></p> </dd> </div> </dl> </div> <script> document.addEventListener('DOMContentLoaded', function() { // Initialize each accordion separately document.querySelectorAll('[data-block="faq-accordion-block"]').forEach(function(accordion) { const accordionId = accordion.dataset.accordionId; const toggles = accordion.querySelectorAll('.faq-toggle'); let currentlyOpen = null; toggles.forEach(function(toggle) { toggle.addEventListener('click', function() { const contentId = this.getAttribute('aria-controls'); const content = document.getElementById(contentId); // If clicking the currently open toggle, close it if (this === currentlyOpen) { this.setAttribute('aria-expanded', 'false'); content.classList.add('hidden'); currentlyOpen = null; return; } // Close currently open item in this accordion if (currentlyOpen) { const openContentId = currentlyOpen.getAttribute('aria-controls'); const openContent = document.getElementById(openContentId); currentlyOpen.setAttribute('aria-expanded', 'false'); openContent.classList.add('hidden'); } // Open clicked item this.setAttribute('aria-expanded', 'true'); content.classList.remove('hidden'); currentlyOpen = this; }); }); }); }); </script></div> <div class="wp-block-column is-layout-flow wp-block-column-is-layout-flow" style="flex-basis:4%"></div> <div class="wp-block-column is-layout-flow wp-block-column-is-layout-flow" style="flex-basis:48%"> <p class="is-style-no-margins has-green-color has-text-color has-link-color wp-elements-ee6d7d0dbdda9f427a6375df6ef9f1b5" style="font-size:25px"><strong>Devices</strong> &amp; Diagnostics</p> <p class="is-style-no-margins" style="font-size:18px">Leverage our team’s extensive experience as you navigate the process of bringing new devices and diagnostics to market and manufacturing them to quality standards.</p> <!-- BLOCK: FAQ ACCORDION --> <div class="tablist accordion-version-two" data-block="faq-accordion-block" data-accordion-id="faq-accordion-67421104b673f"> <dl class=""> <div class="py-[32px] faq-border" style="background-color: #45a24f;"> <dt class="mb-[8px]"> <button type="button" style="background-color: #45a24f; --toggle-color: #FFF;" class="faq-toggle white-font #FFF" aria-controls="faq-accordion-67421104b673f-faq-0" aria-expanded="false"> <p>Areas of expertise</p> </button> </dt> <dd class="hidden faq-content black-font" style="background-color: #ffffff;" id="faq-accordion-67421104b673f-faq-0"> <p><strong>Areas of Expertise:</strong></p> <p>Class I, II, and III devices<br /> Digital Health<br /> Molecular Diagnostics<br /> Immunoassays<br /> Laboratory Tests</p> <p><strong>Learn more about ELIQUENT&#8217;s Medical Devices &amp; Diagnostics Solutions:</strong></p> <p>Medical Devices &amp; Diagnostics Solutions <a href="https://eliquent.com/focus-area/med-device/" target="_blank" rel="noopener">&gt;&gt;</a></p> <p>INFO SHEET: Medical Devices &amp; Diagnostics Solutions <a href="https://eliquent.com/wp-content/uploads/2024/10/MED-DEVICE-Info-Sheet-2024.11.01.pdf" target="_blank" rel="noopener">&gt;&gt;</a></p> </dd> </div> </dl> </div> <script> document.addEventListener('DOMContentLoaded', function() { // Initialize each accordion separately document.querySelectorAll('[data-block="faq-accordion-block"]').forEach(function(accordion) { const accordionId = accordion.dataset.accordionId; const toggles = accordion.querySelectorAll('.faq-toggle'); let currentlyOpen = null; toggles.forEach(function(toggle) { toggle.addEventListener('click', function() { const contentId = this.getAttribute('aria-controls'); const content = document.getElementById(contentId); // If clicking the currently open toggle, close it if (this === currentlyOpen) { this.setAttribute('aria-expanded', 'false'); content.classList.add('hidden'); currentlyOpen = null; return; } // Close currently open item in this accordion if (currentlyOpen) { const openContentId = currentlyOpen.getAttribute('aria-controls'); const openContent = document.getElementById(openContentId); currentlyOpen.setAttribute('aria-expanded', 'false'); openContent.classList.add('hidden'); } // Open clicked item this.setAttribute('aria-expanded', 'true'); content.classList.remove('hidden'); currentlyOpen = this; }); }); }); }); </script></div> </div> <div class="wp-block-columns 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:48%"> <p class="is-style-no-margins has-magenta-color has-text-color has-link-color wp-elements-514fadd039d94b0e5994b13c5a97f999" style="font-size:25px"><strong>Industry</strong> Due Diligence</p> <p class="is-style-no-margins" style="font-size:18px">ELIQUENT applies vast institutional knowledge to equip investors with the information needed to ensure life science transactions account for business objectives, regulatory risks, and the industry landscape.</p> <!-- BLOCK: FAQ ACCORDION --> <div class="tablist accordion-version-two" data-block="faq-accordion-block" data-accordion-id="faq-accordion-67421104b76df"> <dl class=""> <div class="py-[32px] faq-border" style="background-color: #7f3483;"> <dt class="mb-[8px]"> <button type="button" style="background-color: #7f3483; 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const toggles = accordion.querySelectorAll('.faq-toggle'); let currentlyOpen = null; toggles.forEach(function(toggle) { toggle.addEventListener('click', function() { const contentId = this.getAttribute('aria-controls'); const content = document.getElementById(contentId); // If clicking the currently open toggle, close it if (this === currentlyOpen) { this.setAttribute('aria-expanded', 'false'); content.classList.add('hidden'); currentlyOpen = null; return; } // Close currently open item in this accordion if (currentlyOpen) { const openContentId = currentlyOpen.getAttribute('aria-controls'); const openContent = document.getElementById(openContentId); currentlyOpen.setAttribute('aria-expanded', 'false'); openContent.classList.add('hidden'); } // Open clicked item this.setAttribute('aria-expanded', 'true'); content.classList.remove('hidden'); currentlyOpen = this; }); }); }); }); </script></div> <div class="wp-block-column is-layout-flow wp-block-column-is-layout-flow" style="flex-basis:4%"></div> <div class="wp-block-column is-layout-flow wp-block-column-is-layout-flow" style="flex-basis:48%"> <p class="is-style-no-margins has-blue-color has-text-color has-link-color wp-elements-06f3648037bbc09875901d3429902772" style="font-size:25px"><strong>Cosmetics</strong> </p> <p class="is-style-no-margins" style="font-size:18px">ELIQUENT’s knowledge and understanding of the evolving cosmetics regulatory landscape provides clients with a trusted partner when developing and commercializing cosmetic products in compliance with regulations.</p> <!-- BLOCK: FAQ ACCORDION --> <div class="tablist accordion-version-two" data-block="faq-accordion-block" data-accordion-id="faq-accordion-67421104b8864"> <dl class=""> <div class="py-[32px] faq-border" style="background-color: #3578bd;"> <dt class="mb-[8px]"> <button type="button" style="background-color: #3578bd; --toggle-color: #FFF;" class="faq-toggle white-font #FFF" aria-controls="faq-accordion-67421104b8864-faq-0" aria-expanded="false"> <p>Areas of expertise</p> </button> </dt> <dd class="hidden faq-content black-font" style="background-color: #ffffff;" id="faq-accordion-67421104b8864-faq-0"> <p><strong>Areas of Expertise:</strong></p> <p>Product labeling &amp; claims<br /> MoCRA Requirements<br /> Compliance service offerings<br /> Regulatory policy solutions<br /> Expert training</p> <p><strong>Learn more about ELIQUENT&#8217;s Cosmetics Solutions:</strong></p> <p>INFO SHEET: Cosmetics Regulatory Solutions <a href="https://eliquent.com/wp-content/uploads/2024/10/COSMETICS-Info-Sheet-2024.11.01.pdf" target="_blank" rel="noopener">&gt;&gt;</a></p> </dd> </div> </dl> </div> <script> document.addEventListener('DOMContentLoaded', function() { // Initialize each accordion separately document.querySelectorAll('[data-block="faq-accordion-block"]').forEach(function(accordion) { const accordionId = accordion.dataset.accordionId; const toggles = accordion.querySelectorAll('.faq-toggle'); let currentlyOpen = null; toggles.forEach(function(toggle) { toggle.addEventListener('click', function() { const contentId = this.getAttribute('aria-controls'); const content = document.getElementById(contentId); // If clicking the currently open toggle, close it if (this === currentlyOpen) { this.setAttribute('aria-expanded', 'false'); content.classList.add('hidden'); currentlyOpen = null; return; } // Close currently open item in this accordion if (currentlyOpen) { const openContentId = currentlyOpen.getAttribute('aria-controls'); const openContent = document.getElementById(openContentId); currentlyOpen.setAttribute('aria-expanded', 'false'); openContent.classList.add('hidden'); } // Open clicked item this.setAttribute('aria-expanded', 'true'); content.classList.remove('hidden'); currentlyOpen = this; }); }); }); }); </script></div> </div> </div> </div> </div> <!-- Block: background-container --> <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-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> <!-- Block: Callout-grid --> <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> <!-- Block: banner-link --> <div class="banner-link is-style-no-margins alignfull "> <img decoding="async" class="bg-image" src="https://eliquent.com/wp-content/uploads/2024/06/GettyImages-482185539-1-2.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>QMSR Solutions</h2> <p class="copy"><!-- wp:paragraph {"fontSize":"paragraph"} --></p> <p class="has-paragraph-font-size">The FDA’s transition from the Quality System Regulation (QSR) to the new Quality Management System Regulation (QMSR) marks a pivotal shift for the medical device, in-vitro diagnostic, and combination product industry.</p> <p class="has-paragraph-font-size">The migration to QMSR will have far-reaching impact on how medical device manufacturers approach quality management systems.  ELIQUENT Life Sciences is uniquely positioned to support organizations during this critical transformation.</p> <!-- /wp:paragraph --></div> <a class="cta" href="https://eliquent.com/wp-content/uploads/2024/10/QMSR-Info-Sheet-2024.11.01.pdf" target="_blank">Learn More</a> </div> </div> </div> </div> <!-- Block: background-container --> <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> <!-- Block: Global Solutions --> <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 &amp; 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&#8217;s solutions for clients in Japan&#8217;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>&gt;&gt;</strong></a></span></p> </div> </div> </div> </div> </div> </div> </div> <!-- Block: background-container --> <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> <!-- Block: progression --> <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 &#038; 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 Solutions</h3></div></div></div></div><div class="prog-wrap"><div class="prog"><div class="circle"></div><div class="inner1"><div class="inner2"><h3>Talent Solutions</h3></div></div></div></div> </div> <div class="acf-innerblocks-container"> <div class="wp-block-columns is-layout-flex wp-container-core-columns-is-layout-8 wp-block-columns-is-layout-flex"> <div class="wp-block-column is-vertically-aligned-bottom is-layout-flow wp-block-column-is-layout-flow"> <p>From the earliest phases of innovation through <strong>regulatory</strong> submissions, to post- approval support, our robust blend of technical skill and clinical expertise guide companies to approval and beyond.</p> <div class="wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex"> <div class="wp-block-button has-custom-width wp-block-button__width-100"><a class="wp-block-button__link wp-element-button" href="https://eliquent.com/solution/regulatory-affairs/">Learn more</a></div> </div> <p 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 &amp; compliance</strong> experts build customized solutions that equip companies with best-in-class strategic support, technical expertise, and project-based solutions.</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/quality-compliance/">Learn More</a></div> </div> <p class="has-magenta-color has-text-color has-link-color wp-elements-e8e45655dee70373c4e02aba19569cbc"></p> </div> <div class="wp-block-column is-vertically-aligned-bottom is-layout-flow wp-block-column-is-layout-flow"> <p>ELIQUENT&#8217;s <strong>Remediation Solutions </strong>address challenges head-on, providing the expert guidance life science innovators need to bring your operations back into compliance and securing your path forward.</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/remediation-solutions/">Learn More</a></div> </div> <p class="has-validant-blue-color has-text-color has-link-color wp-elements-9d92c98e2759519daae73dde05f6c651"></p> </div> <div class="wp-block-column is-vertically-aligned-bottom is-layout-flow wp-block-column-is-layout-flow"> <p>Whether you need a team of one or 100+, ELIQUENT&#8217;s <strong>talent solutions</strong> gives you the ability to rapidly scale your team to the right size, with the right level of expertise, in the right locations.</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/talent-solutions/">Learn More</a></div> </div> <p class="has-blue-color has-text-color has-link-color wp-elements-173987c3113f5607f84f3071a761f5bd"></p> </div> </div> </div> </div> <div class="button-container"> </div> </div> </div> </div> </div> <!-- Block: background-container --> <div 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&#8217;s regulatory landscape.</p> <!-- Block: resource-icons --> <div class="resource-icons-block is-style-no-margins 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>Global Regulatory<br /> Affairs Solutions</p> </p> <a class="cta" href="https://eliquent.com/wp-content/uploads/2024/11/2024.11.02-PV-Info-Sheet.pdf" target="_blank">Download <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>Quality &amp;<br /> Compliance Solutions</p> </p> <a class="cta" href="https://eliquent.com/wp-content/uploads/2024/10/QC-Info-Sheet-2024.11.01.pdf" target="_blank">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">Quality Systems in Drug Development</h3> <p><p>Read Steven Bowen, Ph.D.&#8217;s article in the <em>Journal of Pharmaceutical Sciences.</em></p> </p> <a class="cta" href="https://eliquent.com/resource/eliquent-expert-…drug-development/" target="_blank">Read more <span aria-hidden="true">></span></a> </div> </div> <div class=" inner" id="bottom-inner"> <img decoding="async" src="https://eliquent.com/wp-content/uploads/2024/08/RESOURCE-Icon-globe-1.svg" alt=""> <div> <h3 class="heading">Case Study: ELIQUENT Outcomes</h3> <p><p>Global regulatory strategy for immunology company to regulatory success.</p> </p> </div> </div> </div> </div> <div class="resource-icons expands" data-index="2"> <div class="content-area"> <h3 class="heading-main heading">SOLUTIONS</h3> <div class="inner"> <img decoding="async" src="https://eliquent.com/wp-content/uploads/2024/10/RESOURCE-Icon-lightbulb.svg" alt=""> <div> <h3 class="heading">Pharmacovigilance &amp; Risk Management Solutions</h3> <p><p>Explore ELIQUENT&#8217;s PV &amp; Risk Management Solutions</p> </p> <a class="cta" href="https://eliquent.com/solution/pharmacovigilance/" target="_blank">Pharmacovigilance &amp; Risk Management <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-lightbulb.svg" alt=""> <div> <h3 class="heading">QMSR Solutions</h3> <p><p>Explore ELIQUENT&#8217;s Quality Management System Regulation (QMSR) Solutions.</p> </p> <a class="cta" href="https://eliquent.com/wp-content/uploads/2024/10/QMSR-Info-Sheet-2024.11.01.pdf" target="_blank">QMSR Solutions <span aria-hidden="true">></span></a> </div> </div> </div> </div> </div> <!-- Block: Featured-Resources-with-heading --> <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-3802" class="featured-resource-with-heading post-3802 resource type-resource status-publish has-post-thumbnail hentry resource_type-news-release"> <a href="https://eliquent.com/resource/shelley-gandhi-joins-eliquent/" style="background-image:url(https://eliquent.com/wp-content/uploads/2024/11/BLOCK-with-overlay18.svg);"> 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style="background-image:url(https://eliquent.com/wp-content/uploads/2024/11/BLOCK-with-overlay20.svg);"> <div class="post-type">resource</div> <p>IQ Central</p> <h3>ELIQUENT Expert Co-Authors Journal Article &#8211; Impact of R&#038;D Quality Systems &#038; Data Integrity in Drug Development</h3> </a> </article> <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> </div> </div> </div> </div> </div> </div> <div style="height:50px" aria-hidden="true" class="wp-block-spacer"></div> <h2 class="wp-block-heading has-text-align-center has-dark-purple-color 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