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Our highly specialized experts provide both strategic direction and hands-on execution services to support clients from the earliest phases of development to post-approval regulatory support.</p> </p> <a class="cta" href="/" target=""> Learn More <span aria-hidden="true">></span> </a> </div> </div> </div> <div class="hero-callout expands"> <div class="content-area"> <div class="colour-line has-blue-background-color"> </div> <div class="inner"> <h3 class="heading">Market Solutions</h3> <p class="copy "><p>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.</p> </p> <a class="cta" href="/" target=""> Learn More <span aria-hidden="true">></span> </a> </div> </div> </div> <div class="hero-callout expands"> <div class="content-area"> <div class="colour-line has-dark-purple-background-color"> </div> <div class="inner"> <h3 class="heading">Global Solutions</h3> <p class="copy "><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" href="/" target=""> Learn More <span aria-hidden="true">></span> </a> </div> </div> </div> </div> </div> <div class="wp-block-columns 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:60%"> <p class="is-style-no-margins has-dark-purple-color has-text-color has-sxlarge-font-size" id="AnnouncementFeature">Introducing </p> <p class="is-style-no-margins has-dark-purple-color has-text-color has-sxlarge-font-size"><strong>ELIQUENT Life Sciences</strong></p> <p class="is-style-default has-splus-font-size">ELIQUENT Life Sciences is a leading global consulting group delivering regulatory affairs, pharmacovigilance, quality, and compliance solutions that support pharmaceutical, biotechnology, medical device, and combination product companies across therapeutic modalities, phase-based pathways, and major global markets.</p> <div style="height:20px" aria-hidden="true" class="wp-block-spacer"></div> <p class="is-style-no-margins has-medium-purple-color has-text-color has-link-color wp-elements-b217dd7d10ab8549df426bb7890a27f9" style="font-size:30px">About <strong>ELIQUENT</strong></p> <p class="is-style-no-margins" style="font-size:18px">ELIQUENT is the singular regulatory resource that clients around the world trust. No matter your pathway position, regulatory requirements, global market or therapeutic area – ELIQUENT’s integrated solutions align with your regulatory goals to unlock regulatory success.</p> <div style="height:30px" aria-hidden="true" class="wp-block-spacer"></div> <p class="is-style-no-margins has-medium-purple-color has-text-color has-link-color wp-elements-a7bc46b0d5ba1caaf63669ed607343cf" style="font-size:30px"><strong>Unprecedented </strong>Assembly</p> <p class="is-style-no-margins" style="font-size:18px">ELIQUENT’s foundation is built on experts with the foremost strategic and technical skill. Our unprecedented assembly of regulatory leaders, industry experts, and technical specialists collaborate seamlessly to deliver objective, reliable guidance across the product lifecycle.</p> <div style="height:30px" aria-hidden="true" class="wp-block-spacer"></div> <p class="is-style-no-margins has-medium-purple-color has-text-color has-link-color wp-elements-316a92ec011ea2a54f089db08e1bff39" style="font-size:30px"><strong>Unmatched </strong>Expertise</p> <p class="is-style-no-margins" style="font-size:18px">With decades of experience in senior positions at the FDA, EMA and throughout industry, ELIQUENT’s team of respected professionals brings unmatched expertise that companies need when working directly with regulators and navigating today’s evolving regulatory environment.</p> <div style="height:30px" aria-hidden="true" class="wp-block-spacer"></div> <p class="is-style-no-margins has-medium-purple-color has-text-color has-link-color wp-elements-69fa2bb6bbe2e2c1db7b29d795a34f64" style="font-size:30px"><strong>Full-Service</strong> Solutions</p> <p class="is-style-no-margins" style="font-size:18px">Our unique platform goes beyond traditional consulting to deliver full-service solutions that equip clients with a premier regulatory resource. Together, we redefine regulatory consulting with integrated solutions that unlock success and clear the path to better health.</p> <div style="height:51px" aria-hidden="true" class="wp-block-spacer"></div> <!-- BLOCK: COPY --> <div class=" my-[0px] copy" data-block="copy-block"> <div class="link-box"> <a class="copy-btn-link" href="https://eliquent.com/resource/info-sheet-full-service-support/" 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: Full-Service Support </a> <a class="copy-btn-link" href="https://eliquent.com/wp-content/uploads/2024/01/2024.01.17.1-ELIQUENT-Complete-Capabilities.pdf" target=""> <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> Slide Deck: Full-Service Solutions </a> </div> </div></div> <div class="wp-block-column is-layout-flow wp-block-column-is-layout-flow" style="flex-basis:33.33%"> <!-- Block: Featured-Resources-Sidebar --> <div class="featured-resources-sidebar" style="border-left: 1px solid #e8ecf0"> <img decoding="async" src="https://eliquent.com/wp-content/uploads/2024/06/iqcentral-1.svg" alt=""> <p class="copy"><p><strong>Unlock Excellence</strong></p> <p>Explore industry insights, expert perspectives, and valuable tools.</p> </p> <div class="resource-articles-cta"> <div class="resources-grid-featured-cta "> <article id="post-3832" class="featured-resource has-dark-image post-3832 resource type-resource status-publish has-post-thumbnail hentry resource_type-blog-article" > <a href="https://eliquent.com/resource/analysis-of-two-fda-guidances-impacting-cgt/" style="background-image:url(https://eliquent.com/wp-content/uploads/2024/10/Colorful-tubes-768x360.png);"> <h3>Analysis of Two FDA Guidances Impacting CGT</h3> </a> </article><article id="post-3837" class="featured-resource has-dark-image post-3837 resource type-resource status-publish has-post-thumbnail hentry resource_type-white-paper" > <a href="https://eliquent.com/resource/best-practices-for-meeting-management-under-pdufa-vi/" style="background-image:url(https://eliquent.com/wp-content/uploads/2024/10/HERO-SHORT-multi-1.svg);"> <h3>Best Practices for Meeting Management Under PDUFA VI</h3> </a> </article><article id="post-3839" class="featured-resource has-dark-image post-3839 resource type-resource status-publish has-post-thumbnail hentry resource_type-white-paper" > <a href="https://eliquent.com/resource/clinical-considerations-in-the-development-of-adcs/" style="background-image:url(https://eliquent.com/wp-content/uploads/2024/10/HERO-SHORT-green.svg);"> <h3>Clinical Considerations in the Development of ADCs</h3> </a> </article> </div> </div> <a class="cta" href="https://eliquent.com/iq-central-landing/" target="">Go to IQ Central</a></div></div> </div> <!-- Block: background-container --> <div class="background-container-block alignfull is-style-no-margins background-image1"> <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-2 wp-block-columns-is-layout-flex"> <div class="wp-block-column is-layout-flow wp-block-column-is-layout-flow" style="flex-basis:100%"> <h2 class="wp-block-heading is-style-default has-dark-purple-color has-text-color has-sxlarge-font-size" id="combined-qualifications"><strong>Combined Qualifications. <br></strong>Unmatched Expertise.</h2> <p class="has-black-color has-text-color has-splus-font-size">ELIQUENT Life Sciences is built on the foundation of six global life science consultancies. Working together as an aligned, coordinated regulatory team, ELIQUENT delivers <strong>comprehensive solutions</strong> that support pharmaceutical, biotechnology, medical device, and combination product companies navigating the complex regulatory landscape.</p> <p class="has-black-color has-text-color has-splus-font-size">This unprecedented assembly of regulatory experts enables a unique understanding of the life sciences industry and the unmatched expertise companies need when navigating today’s evolving regulatory environment.</p> <div style="height:20px" aria-hidden="true" class="wp-block-spacer"></div> </div> </div> <!-- Block: logos --> <div class="logos-block is-style-no-margins"> <div class="logos"> <div class="logo expands"> <div class="inner has-validant-blue-background-color"> <img fetchpriority="high" decoding="async" width="450" height="224" src="https://eliquent.com/wp-content/uploads/2023/11/867f610d41622187538836d8a46a8801-e1704435271859.png" class="attachment-medium_large size-medium_large" alt="" srcset="https://eliquent.com/wp-content/uploads/2023/11/867f610d41622187538836d8a46a8801-e1704435271859.png 450w, https://eliquent.com/wp-content/uploads/2023/11/867f610d41622187538836d8a46a8801-e1704435271859-300x149.png 300w" sizes="(max-width: 450px) 100vw, 450px" /> <button type="button" class="close"><span>Close</span></button> <div class="extra"> <p class="description">A full-service life science consulting firm serving developers and manufacturers of pharmaceuticals, biologics, medical devices, and diagnostics worldwide. Validant provides strategy, execution, and ongoing support for a range of regulatory, compliance, and quality needs.<br /> </p> </div> </div> </div> <div class="logo expands"> <div class="inner has-green-background-color"> <img decoding="async" width="450" height="214" src="https://eliquent.com/wp-content/uploads/2023/11/db207be0f3ec740300cb59a7aae5718c-e1704435234749.png" class="attachment-medium_large size-medium_large" alt="" srcset="https://eliquent.com/wp-content/uploads/2023/11/db207be0f3ec740300cb59a7aae5718c-e1704435234749.png 450w, https://eliquent.com/wp-content/uploads/2023/11/db207be0f3ec740300cb59a7aae5718c-e1704435234749-300x143.png 300w" sizes="(max-width: 450px) 100vw, 450px" /> <button type="button" class="close"><span>Close</span></button> <div class="extra"> <p class="description">A leading FDA regulatory consulting firm that provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies researching, developing, and manufacturing innovative solutions to pressing global public health challenges.</p> </div> </div> </div> <div class="logo expands"> <div class="inner has-dark-purple-background-color"> <img decoding="async" width="450" height="212" src="https://eliquent.com/wp-content/uploads/2023/11/99228883bb8fdcbe813c457f72e0af15-e1704435305341.png" class="attachment-medium_large size-medium_large" alt="" srcset="https://eliquent.com/wp-content/uploads/2023/11/99228883bb8fdcbe813c457f72e0af15-e1704435305341.png 450w, https://eliquent.com/wp-content/uploads/2023/11/99228883bb8fdcbe813c457f72e0af15-e1704435305341-300x141.png 300w" sizes="(max-width: 450px) 100vw, 450px" /> <button type="button" class="close"><span>Close</span></button> <div class="extra"> <p class="description">A regulatory strategy and consultancy firm that focuses on supporting pharma and biotech to navigate the regulatory approval pathway for global clients in the U.S. market. DataRevive&#8217;s legacy team delivers deep real-world regulatory, CMC, preclinical, clinical, and GxP expertise to innovators seeking product approvals in major global markets.</p> </div> </div> </div> <div class="logo expands"> <div class="inner has-medium-purple-background-color"> <img decoding="async" width="450" height="198" src="https://eliquent.com/wp-content/uploads/2023/11/db30fccbc47309f034e01b23f3f2edb9-e1704435366348.png" class="attachment-medium_large size-medium_large" alt="" srcset="https://eliquent.com/wp-content/uploads/2023/11/db30fccbc47309f034e01b23f3f2edb9-e1704435366348.png 450w, https://eliquent.com/wp-content/uploads/2023/11/db30fccbc47309f034e01b23f3f2edb9-e1704435366348-300x132.png 300w" sizes="(max-width: 450px) 100vw, 450px" /> <button type="button" class="close"><span>Close</span></button> <div class="extra"> <p class="description">Regionally specialized regulatory guidance and end-to-end drug product support for pharmaceutical innovators seeking approval in the Japanese market. The legacy IDEC team assists with both design and implementation of market entry, commercialization, and product management strategies.<br /> </p> </div> </div> </div> <div class="logo expands"> <div class="inner has-magenta-background-color"> <img decoding="async" width="450" height="187" src="https://eliquent.com/wp-content/uploads/2023/11/a2c48a7266f82044f5054dcb054fba43-e1704435397592.png" class="attachment-medium_large size-medium_large" alt="" srcset="https://eliquent.com/wp-content/uploads/2023/11/a2c48a7266f82044f5054dcb054fba43-e1704435397592.png 450w, https://eliquent.com/wp-content/uploads/2023/11/a2c48a7266f82044f5054dcb054fba43-e1704435397592-300x125.png 300w" sizes="(max-width: 450px) 100vw, 450px" /> <button type="button" class="close"><span>Close</span></button> <div class="extra"> <p class="description">A global leader in training and consulting for business process improvement, regulatory compliance, and quality management systems. Oriel&#8217;s legacy capabilities support life sciences companies’ programs for compliance with FDA and international regulations, prepares product submissions, and makes their processes more effective and efficient.</p> </div> </div> </div> <div class="logo expands"> <div class="inner has-validant-blue-background-color"> <img decoding="async" width="768" height="549" src="https://eliquent.com/wp-content/uploads/2024/01/Rapport-Logo-KO-1-768x549.png" class="attachment-medium_large size-medium_large" alt="" srcset="https://eliquent.com/wp-content/uploads/2024/01/Rapport-Logo-KO-1-768x549.png 768w, https://eliquent.com/wp-content/uploads/2024/01/Rapport-Logo-KO-1-300x214.png 300w, https://eliquent.com/wp-content/uploads/2024/01/Rapport-Logo-KO-1-1024x732.png 1024w, https://eliquent.com/wp-content/uploads/2024/01/Rapport-Logo-KO-1-728x520.png 728w, https://eliquent.com/wp-content/uploads/2024/01/Rapport-Logo-KO-1.png 1458w" sizes="(max-width: 768px) 100vw, 768px" /> <button type="button" class="close"><span>Close</span></button> <div class="extra"> <p class="description">A UK-based international regulatory consultancy supporting life science innovators as they navigate the regulatory landscape. RApport’s team of highly experienced professionals are experts in European regulatory pathways. RApport’s European expertise extends ELIQUENT’s global capabilities and provides our clients with an expanded portfolio of solutions. In addition to our already robust U.S. and Asia Pacific regulatory capabilities, RApport’s specialized skills bring added value to companies gaining and maintaining authorization for products in the European market.</p> </div> </div> </div> </div> </div> </div> </div> </div> <div style="height:40px" aria-hidden="true" class="wp-block-spacer"></div> <div class="wp-block-group is-layout-constrained wp-block-group-is-layout-constrained"> <h2 class="wp-block-heading has-dark-purple-color has-text-color has-link-color has-sxlarge-font-size wp-elements-7e94fd1984614cdabfb20e6091504bae"><strong>Full-Service </strong>Support</h2> <p class="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 – ELIQUENT’s integrated solutions align with your regulatory goals to unlock regulatory success.</p> <!-- Block: progression --> <div class="progression-block is-style-no-margins hide-prog-mobile"> <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</h3></div></div></div></div><div class="prog-wrap"><div class="prog"><div class="circle"></div><div class="inner1"><div class="inner2"><h3>PV + Safety</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> </div> <div class="button-container"> </div> </div> <!-- BLOCK: FAQ ACCORDION --> <div class="tablist accordion-version-two" data-block="faq-accordion-block" data-accordion-id="faq-accordion-67479fb4c7b23"> <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-67479fb4c7b23-faq-0" aria-expanded="false"> <p>Regulatory Affairs Solutions</p> </button> </dt> <dd class="hidden faq-content black-font" style="background-color: #ffffff;" id="faq-accordion-67479fb4c7b23-faq-0"> <p><!-- wp:paragraph --></p> <p>From the earliest phases of innovation through regulatory submissions, to post-approval support, ELIQUENT’s robust blend of technical skill and clinical expertise guide companies to approval and beyond.</p> <p>&nbsp;</p> <p><!-- /wp:paragraph --> <!-- wp:paragraph --></p> <p><strong>Pipeline Review &amp; Optimization</strong> &#8211; Skilled evaluation and prioritization to effectively manage regulatory risk</p> <p><!-- /wp:paragraph --> <!-- wp:paragraph --></p> <p><strong>Clinical Programs</strong> &#8211; Specialized guidance and strategic design of nonclinical, pre-clinical, and clinical programs</p> <p><!-- /wp:paragraph --> <!-- wp:paragraph --></p> <p><strong>CMC Strategy </strong>&#8211; Risk-based design and effective implementation of phase-appropriate CMC solutions</p> <p><!-- /wp:paragraph --> <!-- wp:paragraph --></p> <p><strong>Pathway Decisions &amp; Eligibility </strong>&#8211; Expert support on product classifications, special designations, and expedited program pathways</p> <p><!-- /wp:paragraph --> <!-- wp:paragraph --></p> <p><strong>Regulatory Meetings &amp; Communications</strong> &#8211; Actionable strategies and insight for milestone meetings and regulatory communications</p> <p><!-- /wp:paragraph --> <!-- wp:paragraph --></p> <p><strong>Regulatory Policy Guidance</strong> &#8211; Customized solutions to understand, implement, and comply with regulatory policies and programs</p> <p><strong>Marketing, Promotion &amp; Labeling</strong> &#8211; Strategic direction on labeling requirements, promotional materials, and marketing programs</p> <p><!-- /wp:paragraph --> <!-- wp:paragraph --></p> <p><strong>Lifecycle Support</strong> &#8211; Valuable expertise throughout the product lifecycle, including post-approval requirements and commitments</p> <p><!-- /wp:paragraph --></p> </dd> </div> <div class="py-[32px] faq-border" style="background-color: #654990;"> <dt class="mb-[8px]"> <button type="button" style="background-color: #654990; --toggle-color: #FFF;" class="faq-toggle white-font #FFF" aria-controls="faq-accordion-67479fb4c7b23-faq-1" aria-expanded="false"> <p>Pharmacovigilance + Risk Management Solutions</p> </button> </dt> <dd class="hidden faq-content black-font" style="background-color: #ffffff;" id="faq-accordion-67479fb4c7b23-faq-1"> <p><!-- wp:paragraph --><br /> With an approach that includes both strategic direction and hands-on global support, ELIQUENT’s customized pharmacovigilance services empower companies to operate with confidence.<br /> &nbsp;</p> <p><!-- /wp:paragraph --> <!-- wp:paragraph --></p> <p><strong>Global Support</strong> &#8211; Trusted guidance when navigating and complying with global pharmacovigilance regulations</p> <p><!-- /wp:paragraph --> <!-- wp:paragraph --></p> <p><strong>Adverse Event Reporting</strong> &#8211; Systematic identification, objective analysis, and strategic guidance responding to unintended occurrences</p> <p><!-- /wp:paragraph --> <!-- wp:paragraph --></p> <p><strong>Regulatory Reporting</strong> &#8211; Technical skill and institutional knowledge of complex regulatory reporting obligations</p> <p><!-- /wp:paragraph --> <!-- wp:paragraph --></p> <p><strong>Signal Detection</strong> &#8211; Expert development and implementation of detection processes, including reporting and risk communication</p> <p><!-- /wp:paragraph --> <!-- wp:paragraph --></p> <p><strong>Risk Assessment &amp; Management</strong> &#8211; Proactive identification, assessment and planning to manage potential risk and ensure regulatory compliance</p> <p><strong>Post-Marketing Surveillance</strong> &#8211; Established network experts to support commercial product safety systems and reporting functions</p> <p><!-- /wp:paragraph --> <!-- wp:paragraph --></p> <p><strong>Risk Communication</strong> &#8211; Strategic development of communications plans to address emerging safety concerns and instill confidence in the market</p> <p><!-- /wp:paragraph --> <!-- wp:paragraph --></p> <p><strong>Clinical Trials Safety Oversight</strong> &#8211; On-demand resources to support safety monitoring before and after regulatory approval</p> <p><!-- /wp:paragraph --></p> </dd> </div> <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-67479fb4c7b23-faq-2" aria-expanded="false"> <p>Quality &amp; Compliance Solutions</p> </button> </dt> <dd class="hidden faq-content black-font" style="background-color: #ffffff;" id="faq-accordion-67479fb4c7b23-faq-2"> <p><!-- wp:paragraph --></p> <p>ELIQUENT’s team of highly specialized compliance experts build customized solutions that equip companies with best-in-class strategic support, technical expertise, and project- based solutions.<br /> &nbsp;</p> <p><!-- /wp:paragraph --> <!-- wp:paragraph --></p> <p><strong>Quality Systems</strong> &#8211; Objective evaluation and expert direction on quality system design, optimization &amp; implementation</p> <p><!-- /wp:paragraph --> <!-- wp:paragraph --></p> <p><strong>Inspectional Readiness</strong> &#8211; Customized strategies to prepare for inspections and align with regulatory expectations</p> <p><!-- /wp:paragraph --> <!-- wp:paragraph --></p> <p><strong>Compliance &amp; Enforcement Actions </strong>&#8211; Proven expertise when responding to regulatory compliance and enforcement actions</p> <p><strong>Regulatory Meetings &amp; Communications </strong>&#8211; Valuable guidance on regulatory communications, meetings, and correspondence</p> <p><strong>Good Clinical Practices</strong> &#8211; Risk-based methodology applied to the design and improvement of clinical quality systems</p> <p><strong>Laboratory Controls &amp; Data Integrity Systems</strong> &#8211; Tailored solutions to ensure data integrity and manufacturing excellence</p> <p><strong>Supply Chain Optimization</strong> &#8211; Skilled support to evaluate and strengthen supply chain management practices</p> <p><strong>Consultation, Training and Regulatory Guidance</strong> &#8211; Strategic insight and actionable strategies spanning the product lifecycle</p> <p><!-- /wp:paragraph --></p> </dd> </div> <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-67479fb4c7b23-faq-3" aria-expanded="false"> <p>Remediation Solutions</p> </button> </dt> <dd class="hidden faq-content black-font" style="background-color: #ffffff;" id="faq-accordion-67479fb4c7b23-faq-3"> <p><!-- wp:paragraph --><br /> Our team of respected professionals and global experts bring an unmatched level of credibility and trust when interacting with regulators and guiding companies to remediation solutions.<br /> &nbsp;<br /> <!-- /wp:paragraph --> <!-- wp:paragraph --></p> <p><strong>Compliance Assessments</strong> &#8211; Strategic and technical evaluations to identify areas of non-compliance &amp; mitigate other potential risks</p> <p><strong>Rapid Response</strong> &#8211; Immediate deployment of compliance experts to provide valuable on-site support when time is of the essence</p> <p><strong>Customized Solutions </strong>&#8211; Actionable remediation plans to correct known problems, prevent future occurrences, and meet regulatory expectations</p> <p><strong>Corrective Action Plans</strong> &#8211; Design and enable action plans that are both effective and sustainable for your business</p> <p><strong>Comprehensive Communications</strong> &#8211; Valuable direction when interacting with and effectively responding to regulatory communications</p> <p><!-- /wp:paragraph --> <!-- wp:paragraph --></p> <p><strong>Implementation Expertise</strong> &#8211; Tailored support to implement both acute and systemic improvements across facilities and product lines</p> <p><strong>On-Demand &amp; On-Site</strong> &#8211; Skilled resources ready to support implementation plans, sustain compliance, and respond to evolving demands</p> <p><strong>Third-Party Reporting</strong> &#8211; Trusted third-party reporting of progress against improvement commitments</p> <p><strong>Maintenance &amp; Monitoring</strong> &#8211; Uphold the integrity of implemented practices with ongoing monitoring and maintenance programs</p> <p><!-- /wp:paragraph --></p> </dd> </div> <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-67479fb4c7b23-faq-4" aria-expanded="false"> <p>Talent Solutions</p> </button> </dt> <dd class="hidden faq-content black-font" style="background-color: #ffffff;" id="faq-accordion-67479fb4c7b23-faq-4"> <p><!-- wp:paragraph --><br /> Whether you need a team of one or 100+, ELIQUENT&#8217;s talent solutions give you the ability to rapidly scale your team to the right size, with the right level of expertise, in the right locations.<br /> &nbsp;</p> <p><!-- /wp:paragraph --> <!-- wp:paragraph --></p> <p><strong>Interim Leadership</strong> &#8211; tailored to the unique needs of the life sciences industry, ELIQUENT’s Interim Leadership Solutions enable organizations to fill temporary leadership gaps with skilled professionals and an eye toward regulatory success.</p> <p><strong>Project Based Teams</strong> &#8211; ELIQUENT’s Interim Project Based Teams provide the expertise, leadership, and support needed to successfully execute project-based objectives on time, within budget, and to the highest quality standards.</p> <p><strong>Contractor Interim Staffing</strong> &#8211; ELIQUENT’s Contractor Interim Staffing Solutions are designed for organizations addressing immediate staffing needs. Our team of experts bridge skills gaps, manage workload fluctuations, and execute specific project initiatives.</p> <p><strong>Functional Service Provider (FSP) Outsourcing</strong> &#8211; ELIQUENT’s Functional Service Provider (FSP) outsourcing solutions provide organizations with custom solutions that deliver specialized expertise, flexible engagement models, and an eye toward meeting your business objectives.</p> <p><strong>Recruitment Process Outsourcing (RPO)</strong> &#8211; Life science innovators rely on ELIQUENT’S Recruitment Process Outsourcing (RPO) Solutions for a streamlined recruitment process that attracts top talent and builds high-performing teams capable of driving business success.</p> <p><!-- /wp:paragraph --></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> <!-- Block: background-container --> <div class="background-container-block alignfull 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-validant-blue-color has-text-color has-link-color has-sxlarge-font-size wp-elements-2e87a7547eaf58c46a1eec10c0046623" id="market-solutions"><strong>Market </strong>Solutions</h2> <p class="is-style-default 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 <strong>decades</strong> of regulatory, quality, safety, and clinical <strong>experience</strong> across markets and therapeutic specialties.</p> <!-- Block: Callout-grid --> <div class="callout-grid-block is-style-no-margins show-mobile-pagination callout-grid" data-columns="3"> <div class="callout expands has-image" data-index="0"> <img decoding="async" width="768" height="771" src="https://eliquent.com/wp-content/uploads/2024/04/WEBSITE-Media-Block-PLUM-768x771.jpg" class="attachment-medium_large size-medium_large" alt="" srcset="https://eliquent.com/wp-content/uploads/2024/04/WEBSITE-Media-Block-PLUM-768x771.jpg 768w, https://eliquent.com/wp-content/uploads/2024/04/WEBSITE-Media-Block-PLUM-300x300.jpg 300w, https://eliquent.com/wp-content/uploads/2024/04/WEBSITE-Media-Block-PLUM-1020x1024.jpg 1020w, https://eliquent.com/wp-content/uploads/2024/04/WEBSITE-Media-Block-PLUM-150x150.jpg 150w, https://eliquent.com/wp-content/uploads/2024/04/WEBSITE-Media-Block-PLUM-1529x1536.jpg 1529w, https://eliquent.com/wp-content/uploads/2024/04/WEBSITE-Media-Block-PLUM-2039x2048.jpg 2039w, https://eliquent.com/wp-content/uploads/2024/04/WEBSITE-Media-Block-PLUM-1900x1908.jpg 1900w, https://eliquent.com/wp-content/uploads/2024/04/WEBSITE-Media-Block-PLUM-518x520.jpg 518w" sizes="(max-width: 768px) 100vw, 768px" /> <div class="content-area"> <div class="colour-line has-magenta-background-color"> </div> <div class="inner"> <h3 class="heading ">Drugs &#038; Biological Products</h3> <p class="copy "><p>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> </p> <a class="cta " href="https://eliquent.com/focus-area/drugs-biologics/" target="">Learn More <span aria-hidden="true">></span></a> </div> </div> </div> <div class="callout expands has-image" data-index="1"> <img decoding="async" width="768" height="769" src="https://eliquent.com/wp-content/uploads/2024/04/WEBSITE-Media-Block-green-768x769.png" class="attachment-medium_large size-medium_large" alt="" srcset="https://eliquent.com/wp-content/uploads/2024/04/WEBSITE-Media-Block-green-768x769.png 768w, https://eliquent.com/wp-content/uploads/2024/04/WEBSITE-Media-Block-green-300x300.png 300w, https://eliquent.com/wp-content/uploads/2024/04/WEBSITE-Media-Block-green-1024x1024.png 1024w, https://eliquent.com/wp-content/uploads/2024/04/WEBSITE-Media-Block-green-150x150.png 150w, https://eliquent.com/wp-content/uploads/2024/04/WEBSITE-Media-Block-green-1536x1536.png 1536w, https://eliquent.com/wp-content/uploads/2024/04/WEBSITE-Media-Block-green-2046x2048.png 2046w, https://eliquent.com/wp-content/uploads/2024/04/WEBSITE-Media-Block-green-1900x1902.png 1900w, https://eliquent.com/wp-content/uploads/2024/04/WEBSITE-Media-Block-green-520x520.png 520w" sizes="(max-width: 768px) 100vw, 768px" /> <div class="content-area"> <div class="colour-line has-lime-green-background-color"> </div> <div class="inner"> <h3 class="heading ">Advanced Therapies &#038; 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Uses the template for the field being rendered. */ #> <div class="nf-field-element">{{{ data.renderElement() }}}</div> <# /* * Render our Description Text. */ #> {{{ data.renderDescText() }}} </div> </script> <script id="tmpl-nf-field-wrap-no-label" type="text/template"> <div id="nf-field-{{{ data.id }}}-wrap" class="{{{ data.renderWrapClass() }}}" data-field-id="{{{ data.id }}}"> <div class="nf-field-label"></div> <div class="nf-field-element">{{{ data.renderElement() }}}</div> <div class="nf-error-wrap"></div> </div> </script> <script id="tmpl-nf-field-wrap-no-container" type="text/template"> {{{ data.renderElement() }}} <div class="nf-error-wrap"></div> </script> <script id="tmpl-nf-field-label" type="text/template"> <div class="nf-field-label"> <# if ( data.type === "listcheckbox" || data.type === "listradio" || data.type === "listimage" || data.type === "date" || data.type === "starrating" ) { #> <span id="nf-label-field-{{{ data.id }}}" class="nf-label-span {{{ 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() }}} </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> <!-- Rich Text Editor Templates --> <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>

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