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<div style="margin-left: auto; margin-right: auto;"> <h1 class="heading"> </h1> </div> </div> </div> <div style="height:50px" aria-hidden="true" class="wp-block-spacer"></div> <h2 class="wp-block-heading is-style-no-margins has-dark-purple-color has-text-color has-sxlarge-font-size"><strong>Medical Device</strong> Solutions</h2> <p class="has-splus-font-size">To ensure success in today’s rapidly evolving biopharmaceutical industry, companies must recognize and be prepared for a dynamic regulatory landscape.</p>  <div class=" my-[0px] copy" data-block="copy-block"> <div class=""> <p></p> <p class="has-sparagraph-font-size">ELIQUENT Life Sciences redefines regulatory consulting with a full-service approach and comprehensive solutions that bridge the spectrum of regulatory challenges. Guided by decades of experience, ELIQUENT’s Medical Device Team supports clients through the complete regulatory process. Our in-depth knowledge and understanding of the global regulatory landscape provides clients with a trusted partner when navigating the complex process of bringing medical technologies to market.</p>  </div> <div class="link-box"> <a class="copy-btn-link" href="https://eliquent.com/wp-content/uploads/2024/10/MED-DEVICE-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: Medical Devices </a> <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:50px" aria-hidden="true" class="wp-block-spacer"></div>  <div class="background-container-block alignfull is-style-no-margins has-lighter-gray-background-color"> <div class="maybe-wrapper"> <div class="acf-innerblocks-container"> <h2 class="wp-block-heading is-style-no-margins has-validant-blue-color has-text-color has-link-color has-sxlarge-font-size wp-elements-65106e92b80f74f359f6148cccf5abad"><strong>Strategic & Technical </strong>Capabilities </h2> <p class="is-style-default has-splus-font-size">ELIQUENT’s unique platform goes beyond traditional consulting to deliver <strong>full-service support</strong>. Our solutions address the entire product lifecycle with best-in-class insight and guidance that bridges the spectrum of regulatory challenges. </p> <p class="is-style-default has-splus-font-size">From the earliest phases of development, through regulatory submissions, to post-approval support, ELIQUENT’s robust blend of technical skill and clinical expertise guide companies <strong>to approval and beyond</strong>.</p> <div style="height:30px" aria-hidden="true" class="wp-block-spacer"></div>  <div class="callout-grid-block is-style-no-margins show-mobile-pagination callout-grid" data-columns="2"> <div class="callout expands no-image" data-index="0"> <div class="content-area"> <div class="colour-line has-validant-blue-background-color"> </div> <div class="inner"> <h3 class="heading no-image">Regulatory Expertise</h3> <p class="copy no-image"><p>Guided by former FDA, EMA, and industry leaders, ELIQUENT collaborates seamlessly to provide the strategic and technical guidance that unlocks excellence throughout the product lifecycle.</p> </p> </div> </div> </div> <div class="callout expands no-image" data-index="1"> <div class="content-area"> <div class="colour-line has-dark-purple-background-color"> </div> <div class="inner"> <h3 class="heading no-image">Digital Health</h3> <p class="copy no-image"><p class="p1">ELIQUENT experts provide guidance to clients developing, commercializing, utilizing, and investing in innovative digital health technologies as they navigate the evolving landscape of digital health regulatory requirements.</p> </p> </div> </div> </div> <div class="callout expands no-image" data-index="2"> <div class="content-area"> <div class="colour-line has-magenta-background-color"> </div> <div class="inner"> <h3 class="heading no-image">Quality & Manufacturing</h3> <p class="copy no-image"><p class="p1">ELIQUENT’s experts build customized solutions that equip companies with best-in-class solutions to ensure their medical devices and combination products are manufactured according to applicable quality standards and regulations.</p> </p> </div> </div> </div> <div class="callout expands no-image" data-index="3"> <div class="content-area"> <div class="colour-line has-green-background-color"> </div> <div class="inner"> <h3 class="heading no-image">Combination Products</h3> <p class="copy no-image"><p class="p1">ELIQUENT experts are a valued partner to sponsors when determining how regulatory agencies will likely regulate their combination products throughout the product lifecycle.</p> </p> </div> </div> </div> <div class="callout expands no-image" data-index="4"> <div class="content-area"> <div class="colour-line has-lime-green-background-color"> </div> <div class="inner"> <h3 class="heading no-image">Premarket Pathway & Submissions</h3> <p class="copy no-image"><p class="p1">Guided by decades of regulatory experience, ELIQUENT experts work with companies to determine the best pathway to market for a product and develop a comprehensive strategy to achieve a successful result.</p> </p> </div> </div> </div> <div class="callout expands no-image" data-index="5"> <div class="content-area"> <div class="colour-line has-blue-background-color"> </div> <div class="inner"> <h3 class="heading no-image">Marketing & Promotional Practices</h3> <p class="copy no-image"><p class="p1">ELIQUENT provides companies with regulatory support on product labeling and promotional materials, including direct-to consumer (DTC) promotion on social media and assistance with remediating alleged promotional violations.</p> </p> </div> </div> </div> <div class="pagination"> <svg class="pagination-circle" data-page="0" xmlns="http://www.w3.org/2000/svg" width="26" height="26" viewBox="0 0 26 26" fill="none"> <circle cx="12.8" cy="12.8" r="12.8" transform="rotate(-90 12.8 12.8)" fill="#3E3D3D" /> </svg> <svg class="pagination-circle" data-page="1" xmlns="http://www.w3.org/2000/svg" width="26" height="26" viewBox="0 0 26 26" fill="none"> <circle cx="12.8" cy="12.8" r="12.8" transform="rotate(-90 12.8 12.8)" fill="#BBBABA" /> </svg> </div> </div> <script> document.addEventListener("DOMContentLoaded", function() { const calloutGridBlock = document.querySelector(".callout-grid-block"); const noImageCallouts = document.querySelectorAll(".callout.no-image"); // Check if there are any .callout elements with the .no-image class if (noImageCallouts.length > 0 && calloutGridBlock) { // Remove row-gap when .no-image is detected calloutGridBlock.style.rowGap = "30px"; } }); </script> </div> </div> </div>  <div class="background-container-block alignfull has-validant-blue-background-color"> <div class="maybe-wrapper"> <div class="acf-innerblocks-container">  <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>  <div class="background-container-block alignfull is-style-no-margins background-none"> <div class="maybe-wrapper"> <div class="acf-innerblocks-container"> <h2 class="wp-block-heading is-style-default has-dark-purple-color has-text-color has-link-color has-sxlarge-font-size wp-elements-44d4f6385cf5a74222419a1c030f0013"><strong>Unmatched</strong> Expertise</h2> <p class="is-style-default has-splus-font-size">Our unprecedented assembly of regulatory leaders, industry experts, and technical specialists set the standard for regulatory consulting excellence. With <strong>decades of experience</strong> in senior positions at the FDA, EMA, and throughout industry, ELIQUENT’s team of respected professionals brings unmatched expertise that companies need when <strong>working directly with the regulators</strong> and when navigating today’s evolving regulatory environment.</p> <div class="wp-block-columns is-style-default is-layout-flex wp-container-core-columns-is-layout-1 wp-block-columns-is-layout-flex"> <div class="wp-block-column is-vertically-aligned-top is-layout-flow wp-block-column-is-layout-flow" style="flex-basis:25%"> <figure class="wp-block-image size-medium is-resized is-style-default"><a href="https://eliquent.com/team/michele-dougherty/"><img fetchpriority="high" decoding="async" width="300" height="300" src="https://eliquent.com/wp-content/uploads/2023/12/DOUGHERTY_MICHELE-WEB-headshot-FINAL-1080.2-300x300.png" alt="" class="wp-image-606" style="box-shadow:var(--wp--preset--shadow--natural);aspect-ratio:1;object-fit:contain;width:250px" srcset="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-1080.2-1024x1024.png 1024w, 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: 300px) 100vw, 300px" /></a></figure> <h2 class="wp-block-heading is-style-no-margins has-validant-blue-color has-text-color has-link-color has-sparagraph-font-size wp-elements-a064c904d2852c85ecc6efdb9b2c59f3">Michele <strong>Dougherty</strong>, Ph.D.</h2> </div> <div class="wp-block-column is-vertically-aligned-top is-layout-flow wp-block-column-is-layout-flow" style="flex-basis:25%"> <figure class="wp-block-image size-medium is-resized is-style-default"><a href="https://eliquent.com/team/daniel-schultz-md-f-a-c-s/"><img decoding="async" width="300" height="300" src="https://eliquent.com/wp-content/uploads/2023/12/SCHULTZ_DAN-WEB-headshot-300x300.png" alt="" class="wp-image-678" style="box-shadow:var(--wp--preset--shadow--natural);aspect-ratio:1;object-fit:contain;width:250px" srcset="https://eliquent.com/wp-content/uploads/2023/12/SCHULTZ_DAN-WEB-headshot-300x300.png 300w, https://eliquent.com/wp-content/uploads/2023/12/SCHULTZ_DAN-WEB-headshot-1024x1024.png 1024w, https://eliquent.com/wp-content/uploads/2023/12/SCHULTZ_DAN-WEB-headshot-150x150.png 150w, https://eliquent.com/wp-content/uploads/2023/12/SCHULTZ_DAN-WEB-headshot-768x768.png 768w, https://eliquent.com/wp-content/uploads/2023/12/SCHULTZ_DAN-WEB-headshot-520x520.png 520w, https://eliquent.com/wp-content/uploads/2023/12/SCHULTZ_DAN-WEB-headshot.png 1080w" sizes="(max-width: 300px) 100vw, 300px" /></a></figure> <h2 class="wp-block-heading is-style-default has-validant-blue-color has-text-color has-link-color has-sparagraph-font-size wp-elements-2cb6f70ac9bd99026f6ef5d788b1c62b">Dan <strong>Schultz</strong>, M.D.</h2> </div> <div class="wp-block-column is-vertically-aligned-top is-layout-flow wp-block-column-is-layout-flow" style="flex-basis:25%"> <figure class="wp-block-image size-medium is-resized is-style-default"><a href="https://eliquent.com/team/mark-d-kramer/"><img decoding="async" width="300" height="300" src="https://eliquent.com/wp-content/uploads/2024/01/KRAMER_MARK-WEB-headshot-300x300.png" alt="" class="wp-image-659" style="box-shadow:var(--wp--preset--shadow--natural);aspect-ratio:1;object-fit:contain;width:250px" srcset="https://eliquent.com/wp-content/uploads/2024/01/KRAMER_MARK-WEB-headshot-300x300.png 300w, https://eliquent.com/wp-content/uploads/2024/01/KRAMER_MARK-WEB-headshot-1024x1024.png 1024w, https://eliquent.com/wp-content/uploads/2024/01/KRAMER_MARK-WEB-headshot-150x150.png 150w, https://eliquent.com/wp-content/uploads/2024/01/KRAMER_MARK-WEB-headshot-768x768.png 768w, https://eliquent.com/wp-content/uploads/2024/01/KRAMER_MARK-WEB-headshot-520x520.png 520w, https://eliquent.com/wp-content/uploads/2024/01/KRAMER_MARK-WEB-headshot.png 1080w" sizes="(max-width: 300px) 100vw, 300px" /></a></figure> <h2 class="wp-block-heading is-style-default has-validant-blue-color has-text-color has-link-color has-sparagraph-font-size wp-elements-fbc2b91bfa4c20aa84aa4b5f871bc940">Mark <strong>Kramer</strong></h2> </div> <div class="wp-block-column is-vertically-aligned-top is-layout-flow wp-block-column-is-layout-flow" style="flex-basis:25%"> <figure class="wp-block-image size-medium is-resized is-style-default"><a href="https://eliquent.com/team/heather-s-rosecrans-f-r-a-p-s/"><img decoding="async" width="300" height="300" src="https://eliquent.com/wp-content/uploads/2023/12/ROSECRANS_HEATHER-WEB-headshot-300x300.png" alt="" class="wp-image-685" style="box-shadow:var(--wp--preset--shadow--natural);aspect-ratio:1;object-fit:contain;width:250px" srcset="https://eliquent.com/wp-content/uploads/2023/12/ROSECRANS_HEATHER-WEB-headshot-300x300.png 300w, https://eliquent.com/wp-content/uploads/2023/12/ROSECRANS_HEATHER-WEB-headshot-1022x1024.png 1022w, https://eliquent.com/wp-content/uploads/2023/12/ROSECRANS_HEATHER-WEB-headshot-150x150.png 150w, https://eliquent.com/wp-content/uploads/2023/12/ROSECRANS_HEATHER-WEB-headshot-768x769.png 768w, https://eliquent.com/wp-content/uploads/2023/12/ROSECRANS_HEATHER-WEB-headshot-519x520.png 519w, https://eliquent.com/wp-content/uploads/2023/12/ROSECRANS_HEATHER-WEB-headshot.png 1078w" sizes="(max-width: 300px) 100vw, 300px" /></a></figure> <h2 class="wp-block-heading is-style-default has-validant-blue-color has-text-color has-link-color has-sparagraph-font-size wp-elements-9d693f81743432d83f465165ed3b3b3e">Heather <strong>Rosecrans</strong></h2> </div> </div> <div class="wp-block-buttons is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-1 wp-block-buttons-is-layout-flex"> <div class="wp-block-button is-style-fill"><a class="wp-block-button__link has-validant-blue-background-color has-background wp-element-button" href="https://eliquent.com/team/">See Full Team</a></div> </div> </div> </div> </div>  <div class="background-container-block alignfull is-style-no-margins has-lighter-gray-background-color"> <div class="maybe-wrapper"> <div class="acf-innerblocks-container"> <h2 class="wp-block-heading is-style-no-margins has-dark-purple-color has-text-color has-link-color has-sxlarge-font-size wp-elements-f9bc9086936483a761bc8ef9c949e553"><strong>Combination Product</strong> Solutions</h2> <p class="has-splus-font-size">As former regulators and industry leaders, our understanding of the product lifecycle is unrivaled. ELIQUENT’s highly specialized combination product experts provide both strategic direction and technical support from the earliest phases of development to post-approval regulatory support.</p> <p class="is-style-default has-splus-font-size"><strong>ELIQUENT’s Combination Product Solutions include:</strong></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-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-Distribution-Blue.svg" alt="" class="wp-image-3163 size-thumbnail"/></figure><div class="wp-block-media-text__content"> <p class="is-style-no-margins" style="font-size:22px"><strong>Product </strong>Classification</p> <p class="is-style-no-margins" style="font-size:16px">The ELIQUENT team provides strategic and technical guidance to determine a product’s regulatory identity (classification) as a drug, device, biological product, or combination product.</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-Read-Purple.svg" alt="" class="wp-image-3068 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 strategies that optimize a product’s regulatory submission and agency interactions at every step..</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-Green.svg" alt="" class="wp-image-3139 size-thumbnail"/></figure><div class="wp-block-media-text__content"> <p class="is-style-no-margins" style="font-size:22px"><strong>Premarket</strong> Pathway</p> <p class="is-style-no-margins" style="font-size:16px">Guided by decades of regulatory experience, ELIQUENT experts provide best-in-class premarket support across all potential pathways, including: NDA, ANDA, BLA, PMA, 510(k), De Novo.</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>Quality & </strong>Manufacturing</p> <p class="is-style-no-margins" style="font-size:16px">ELIQUENT evaluates and strengthens systems with an eye toward optimizing processes, mitigating risks, and creating a culture of compliance, while meeting business objectives.</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-Compass-Plum.svg" alt="" class="wp-image-3131 size-thumbnail"/></figure><div class="wp-block-media-text__content"> <p class="is-style-no-margins" style="font-size:22px"><strong>Expert </strong>Training</p> <p class="is-style-no-margins" style="font-size:16px">ELIQUENT experts create training solutions across the entire product life cycle that empower teams to elevate regulatory compliance and optimize quality management practices.</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-Lightbulb-Blue.svg" alt="" class="wp-image-3150 size-thumbnail"/></figure><div class="wp-block-media-text__content"> <p class="is-style-no-margins" style="font-size:22px"><strong>Learn</strong> More</p> <p class="is-style-no-margins" style="font-size:16px">Explore ELIQUENT’s combination product capabilities:</p> <div style="height:8px" aria-hidden="true" class="wp-block-spacer"></div> <p class="is-style-no-margins has-validant-blue-color has-text-color has-link-color wp-elements-a0fd80b512804fd54eda6bc0c4bf3588" style="font-size:18px">Combo Product <strong>Solutions</strong> <a href="https://eliquent.com/focus-area/combination-products/">>></a></p> <p class="is-style-no-margins has-validant-blue-color has-text-color has-link-color wp-elements-12aa3d39615ecadde72d57d674b289e8" style="font-size:18px"><strong>Info Sheet</strong>: Combo Products <a href="https://eliquent.com/wp-content/uploads/2024/10/COMBO-PRODUCTS-Info-Sheet-2024.11.01.pdf">>></a></p> </div></div> </div> </div> </div> </div> </div>  <div class="background-container-block alignfull is-style-no-margins background-none"> <div class="maybe-wrapper"> <div class="acf-innerblocks-container"> <h2 class="wp-block-heading is-style-no-margins has-dark-purple-color has-text-color has-link-color has-sxlarge-font-size wp-elements-3a4260246a53a8039446d1f5071aea7f"><strong>LDT</strong> Solutions</h2> <p class="has-splus-font-size">For decades, Laboratory Developed Tests (LDTs) have been subject to limited regulatory oversight compared to other diagnostic tests, allowing laboratories to develop and use these tests with greater flexibility. As LDTs have become increasingly sophisticated and commercially widespread, the FDA has moved to increase its oversight, signaling a shift toward more rigorous regulatory requirements.</p> <p>The FDA’s new regulatory framework, aimed at bringing LDTs under the same level of scrutiny as other in vitro diagnostic devices (IVDs), will have a far-reaching impact for manufacturers operating in this space. This shift underscores the critical need for companies developing LDTs to establish robust quality and regulatory systems that maintain compliance and ensure product quality.</p> <p class="is-style-default has-sparagraph-font-size">As the LDT landscape continues to evolve, a trusted regulatory partner is crucial to stay ahead of regulatory challenges. ELIQUENT Life Sciences is uniquely positioned to support organizations during this critical transformation. Our unprecedented assembly of regulatory leaders, industry experts, and technical specialists partner with LDT companies to maintain compliance, ensure product quality, and remain competitive in an evolving regulatory landscape. </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-097624e41f0e6ab5957fcbc297ab752d" style="font-size:25px"><strong>Regulatory </strong>Strategy Development</p> <p style="font-size:18px">ELIQUENT collaborates with companies to develop a clear, effective strategy to determine the appropriate regulatory pathway and ensure your LDT meets FDA requirements.</p>  <div class="tablist accordion-version-two" data-block="faq-accordion-block" data-accordion-id="faq-accordion-67428f51061a2"> <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-67428f51061a2-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-67428f51061a2-faq-0"> <p class="p1"><strong>Comprehensive regulatory strategy roadmap:</strong></p> <p class="p1">Pathway identification (e.g., 510(k), PMA, or de novo)</p> <p class="p1">Identification of classification and submission requirements</p> <p class="p1">Tailored recommendations for expedited FDA approval, where applicable</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-cd6baf95189335c051d5d837fa4f169d" style="font-size:25px">Pre-<strong>Submission </strong>Consultation</p> <p class="is-style-no-margins" style="font-size:18px">We assist in preparing pre-submission packages (Pre-Subs) and facilitate meetings with the FDA to obtain feedback on your product, reducing the risk of rejections or delays.</p>  <div class="tablist accordion-version-two" data-block="faq-accordion-block" data-accordion-id="faq-accordion-67428f5106c84"> <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-67428f5106c84-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-67428f5106c84-faq-0"> <p class="p1"><strong>From preparing pre-submission materials to supporting you through the full FDA review process, our team ensures that your regulatory submission is precise and complete.</strong></p> <p class="p1">Detailed Pre-Submission (Q-Submission) package preparation</p> <p class="p1">Pre-submission question formulation to optimize feedback</p> <p class="p1">Full support for FDA interactions, including meeting prep and follow-up</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-magenta-color has-text-color has-link-color wp-elements-713e5eed5ff8b36e443b3c5f2376be4b" style="font-size:25px"><strong>Submission</strong> Preparation & Support</p> <p class="is-style-no-margins" style="font-size:18px">From initial submission through to approval, ELIQUENT guides innovators in compiling all required documentation, preparing submissions, and ensuring a smooth regulatory review process.</p>  <div class="tablist accordion-version-two" data-block="faq-accordion-block" data-accordion-id="faq-accordion-67428f510773d"> <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-67428f510773d-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-67428f510773d-faq-0"> <p class="p1"><span class="s1"><b>Strategic & technical direction</b></span></p> <p class="p1">Preparation of 510(k), PMA, or de novo submissions</p> <p class="p1">Technical file and supporting documentation development (e.g., device description, labeling, performance data)</p> <p class="p1">Review of predicate devices (if applicable) for 510(k) submissions</p> <p class="p1">Assistance with responses to FDA requests for additional information (AI letters)</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-blue-color has-text-color has-link-color wp-elements-cec2163cbbb923d3803f8616845db045" style="font-size:25px"><strong>QMS</strong> Development & Implementation</p> <p class="is-style-no-margins" style="font-size:18px">ELIQUENT collaborates with companies to establish and maintain a robust QMS that meets FDA’s Quality Management System Regulation (QMSR), ensuring your laboratory is audit-ready and compliant at all times.</p>  <div class="tablist accordion-version-two" data-block="faq-accordion-block" data-accordion-id="faq-accordion-67428f510818d"> <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-67428f510818d-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-67428f510818d-faq-0"> <p class="p1"><span class="s1"><b>Customized solutions:</b></span></p> <p class="p1">Comprehensive QMS design, tailored for LDT manufacturing</p> <p class="p1">Procedures for document control, corrective and preventive actions (CAPA), and supplier management</p> <p class="p1">Internal audit plans and audit preparation</p> <p class="p1">Ongoing QMS maintenance and continuous improvement support</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-green-color has-text-color has-link-color wp-elements-18c646b19f9c2a8d138b06390cf734ec" style="font-size:25px">FDA <strong>Inspection</strong> Readiness</p> <p class="is-style-no-margins" style="font-size:18px">ELIQUENT’s regulatory experts develop and implement custom strategies that prepare companies for FDA inspectional responsibilities, while aligning with global regulatory standards and expectations.</p>  <div class="tablist accordion-version-two" data-block="faq-accordion-block" data-accordion-id="faq-accordion-67428f5108cdd"> <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-67428f5108cdd-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-67428f5108cdd-faq-0"> <p class="p1"><span class="s1"><b>Actionable and proven strategies:</b></span></p> <p class="p1">Mock FDA inspections to assess readiness</p> <p class="p1">Detailed inspection response plan development</p> <p class="p1">Post-market reporting, adverse event monitoring, and CAPA implementation</p> <p class="p1">Establishment of product recalls or field actions protocols</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-dark-purple-color has-text-color has-link-color wp-elements-b4201dbe568d1959d3665d998b36a5bd" style="font-size:25px"><strong>Labeling </strong>& Marketing Compliance</p> <p class="is-style-no-margins" style="font-size:18px">Our deep bench of former FDA officials and industry experts ensure your LDT’s labeling and marketing materials comply with FDA regulations and avoid enforcement actions for misbranding.</p>  <div class="tablist accordion-version-two" data-block="faq-accordion-block" data-accordion-id="faq-accordion-67428f5109b82"> <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-67428f5109b82-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-67428f5109b82-faq-0"> <p class="p1"><strong>Customized solutions:</strong></p> <p class="p1">Review and development of compliant product labeling</p> <p class="p1">Marketing claims validation to align with regulatory submissions</p> <p class="p1">Support for advertising, promotional material reviews, and labeling audits</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-8 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-be960fa26e1ae3bad2f16bf8a08fecde" style="font-size:25px"><strong>Clinical </strong>Evidence</p> <p class="is-style-no-margins" style="font-size:18px">ELIQUENT supports the generation of clinical evidence needed for regulatory submissions, including clinical study design, data collection, and management.</p>  <div class="tablist accordion-version-two" data-block="faq-accordion-block" data-accordion-id="faq-accordion-67428f510a61b"> <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-67428f510a61b-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-67428f510a61b-faq-0"> <p class="p1"><strong>Real-world guidance:</strong></p> <p class="p1">Clinical performance study protocols</p> <p class="p1">Data collection and analysis support</p> <p class="p1">Clinical trial oversight and compliance with GCP (Good Clinical Practice) standards</p> <p class="p1">Clinical study report (CSR) preparation for FDA submissions</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-magenta-color has-text-color has-link-color wp-elements-890199bd435ee73e74d976ca4e692e0b" style="font-size:25px"><strong>Supplier</strong> Management</p> <p class="is-style-no-margins" style="font-size:18px">ELIQUENT assess, qualifies and provides management for critical suppliers, ensuring they meet regulatory requirements for LDT manufacturing. </p>  <div class="tablist accordion-version-two" data-block="faq-accordion-block" data-accordion-id="faq-accordion-67428f510b0b5"> <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-67428f510b0b5-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-67428f510b0b5-faq-0"> <p class="p1"><strong>Valuable & objective guidance:</strong></p> <p class="p1">Supplier audits and qualification protocols</p> <p class="p1">Supplier risk assessments</p> <p class="p1">Supplier agreements and quality contracts development</p> <p class="p1">Ongoing supplier performance monitoring</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-9 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-blue-color has-text-color has-link-color wp-elements-620a9a25e40addc6365abac1580896d8" style="font-size:25px"><strong>Consultation, </strong>Training & Guidance</p> <p class="is-style-no-margins" style="font-size:18px">ELIQUENT’s team provides market leading insight  and training that equips companies with solutions that reduce the risk of non-compliance while enhancing operational efficiency, product quality, and market access.</p>  <div class="tablist accordion-version-two" data-block="faq-accordion-block" data-accordion-id="faq-accordion-67428f510c430"> <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-67428f510c430-faq-0" aria-expanded="false"> <p>Explore opportunities</p> </button> </dt> <dd class="hidden faq-content black-font" style="background-color: #005178;" id="faq-accordion-67428f510c430-faq-0"> <p class="p1">Built on the industry’s largest portfolio of quality and regulatory training content, ELIQUENT experts create training solutions that empower teams to elevate regulatory compliance.</p> <p>Learn more about ELIQUENT’s Expert Training Solutions:</p> <p>Expert Training Solutions <a href="https://eliquent.com/focus-area/expert-training/"><strong>>></strong></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-magenta-color has-text-color has-link-color wp-elements-38c3783b331bd4510c407a5d7a8c8249" style="font-size:25px"><strong>LDT </strong>Solutions</p> <p class="is-style-no-margins" style="font-size:18px">Explore ELIQUENT’S comprehensive capabilities for innovators facing regulation in the LDT market. </p> <div style="height:10px" aria-hidden="true" class="wp-block-spacer"></div> <p class="is-style-no-margins has-magenta-color has-text-color has-link-color wp-elements-60a669ab110216e0a84625436e80354f" style="font-size:18px"><strong>Info Sheet</strong>: LDT Solutions <a href="https://eliquent.com/wp-content/uploads/2024/10/COMBO-PRODUCTS-Info-Sheet-2024.11.01.pdf">>></a></p>  <div class="tablist accordion-version-two" data-block="faq-accordion-block" data-accordion-id="faq-accordion-67428f510d3ad"> <dl class=""> </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>  <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="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="copy"> </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> </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>  <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>  <div class="callout-grid-block is-style-no-margins hide-mobile-pagination callout-grid" data-columns="3"> <div class="callout expands no-image" data-index="0"> <div class="content-area"> <div class="colour-line has-magenta-background-color"> </div> <div class="inner"> <h3 class="heading no-image">Market Solutions</h3> <p class="copy no-image"><p>Guided by decades of regulatory and clinical experience, our premier team of life science experts have the specialized skills to assist clients across therapeutic areas, modalities and markets.</p> </p> <a class="cta no-image" href="https://eliquent.com/focus-areas-landing/#market-solutions" target="">Market Solutions <span aria-hidden="true">></span></a> </div> </div> </div> <div class="callout expands no-image" data-index="1"> <div class="content-area"> <div class="colour-line has-lime-green-background-color"> </div> <div class="inner"> <h3 class="heading no-image">Pathway Solutions</h3> <p class="copy no-image"><p>As former regulators and industry leaders, our understanding of the product lifecycle is unrivaled. Clients turn to our team for strategic direction and hands-on execution services that support the earliest phases of development to post-approval and beyond.</p> </p> <a class="cta no-image" href="https://eliquent.com/focus-areas-landing/#pathway-solutions" target="">Pathway Solutions <span aria-hidden="true">></span></a> </div> </div> </div> <div class="callout expands no-image" data-index="2"> <div class="content-area"> <div class="colour-line has-blue-background-color"> </div> <div class="inner"> <h3 class="heading no-image">Global Solutions</h3> <p class="copy no-image"><p>ELIQUENT’S established and growing global presence spans the regulatory process and major markets. Our premier team of global regulatory experts support markets across the U.S., Europe, and Asia.</p> </p> <a class="cta no-image" href="https://eliquent.com/focus-areas-landing/#global_solutions" target="">Global Solutions <span aria-hidden="true">></span></a> </div> </div> </div> <div class="pagination"> <svg class="pagination-circle" data-page="0" xmlns="http://www.w3.org/2000/svg" width="26" height="26" viewBox="0 0 26 26" fill="none"> <circle cx="12.8" cy="12.8" r="12.8" transform="rotate(-90 12.8 12.8)" fill="#3E3D3D" /> </svg> <svg class="pagination-circle" data-page="1" xmlns="http://www.w3.org/2000/svg" width="26" height="26" viewBox="0 0 26 26" fill="none"> <circle cx="12.8" cy="12.8" r="12.8" transform="rotate(-90 12.8 12.8)" fill="#BBBABA" /> </svg> </div> </div> <script> document.addEventListener("DOMContentLoaded", function() { const calloutGridBlock = document.querySelector(".callout-grid-block"); const noImageCallouts = document.querySelectorAll(".callout.no-image"); // Check if there are any .callout elements with the .no-image class if (noImageCallouts.length > 0 && calloutGridBlock) { // Remove row-gap when .no-image is detected calloutGridBlock.style.rowGap = "30px"; } }); </script> </div> </div> </div>  <div class="background-container-block alignfull is-style-no-margins has-light-blue-background-color"> <div class="maybe-wrapper"> <div class="acf-innerblocks-container"> <h2 class="wp-block-heading is-style-default has-dark-purple-color has-text-color has-link-color has-sxlarge-font-size wp-elements-8402806101e578f34c9b6331c17d3c56"><strong>Global</strong> Solutions</h2> <p class="has-splus-font-size"><strong>Expertise beyond borders. </strong>ELIQUENT’S established and growing global presence spans the regulatory process and major markets. Our premier team of global regulatory experts support markets across the U.S., Europe, and Asia.</p>  <div class="global-solutions is-style-no-margins"> <h3 class="main-heading"></h3> <div class="globe-outer-container"> <a class="highlight-united-states"></a> <a class="highlight-europe"></a> <a class="highlight-asia"></a> <div class="globe-inner-container"> <img decoding="async" src="https://eliquent.com/wp-content/uploads/2024/06/Globe-1.svg" alt=""> </div> </div> <div class="united-states-content"> <div> <h3 class="content-heading united-states-heading">United States</h3> <div class="content-description"><p class="content-description">ELIQUENT is a leading Food & Drug Administration (FDA) regulatory consulting firm that provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies.<br /> Our experts have shaped the landscape of FDA regulatory policy and strategy for decades. We bring this unrivaled knowledge and unique insight to our work with clients every day.</p> </div> </div> <svg class="united-states-line" xmlns="http://www.w3.org/2000/svg" width="83" height="157" viewBox="0 0 83 157" fill="none"> <path d="M2 0.5V155H83" stroke="#7F3483" stroke-width="3" stroke-dasharray="6 6" /> </svg> </div> <div class="europe-content"> <svg class="europe-line" xmlns="http://www.w3.org/2000/svg" width="116" height="191" viewBox="0 0 116 191" fill="none"> <path d="M114 0L114 189L3.14663e-06 189" stroke="#005178" stroke-width="3" stroke-dasharray="6 6" /> </svg> <div> <h3 class="content-heading europe-heading">Europe</h3> <div class="content-description"><p class="content-description">The ELIQUENT team applies their deep and diverse knowledge of European regulations to keep clients in lock-step with evolving global standards. With decades of experience in the European market, our team understands the intricacies of the European Medicines Agency (EMA) and offers tailored solutions to ensure products meet and exceed the needs of our clients.</p> </div> </div> </div> <div class="asia-content"> <svg class="asia-line" xmlns="http://www.w3.org/2000/svg" width="116" height="122" viewBox="0 0 116 122" fill="none"> <path d="M114 0L114 120L-4.77154e-07 120" stroke="#48A24F" stroke-width="3" stroke-dasharray="6 6" /> </svg> <div> <h3 class="content-heading asia-heading">Asia</h3> <div class="content-description"><p class="content-description">ELIQUENT offers regionally specialized solutions for the innovators across Asia. Our comprehensive solutions include expert guidance to innovators seeking approval in Japan, the third-largest pharmaceutical market in the world. Explore ELIQUENT’s solutions for clients in Japan’s life sciences market.</p> <p class="content-description"><strong>Explore ELIQUENT Japan</strong> <span style="color: #339966"><a style="color: #339966" href="https://eliquent.com/wp-content/uploads/2024/10/REG-AFFAIRS-JAPAN-Info-Sheet-2024.11.01.pdf" target="_blank" rel="noopener"><strong>>></strong></a></span></p> </div> </div> </div> </div> </div> </div> </div>  <div class="background-container-block alignfull is-style-no-margins has-lighter-gray-background-color"> <div class="maybe-wrapper"> <div class="acf-innerblocks-container"> <h2 class="wp-block-heading is-style-no-margins has-dark-purple-color has-text-color has-link-color has-sxlarge-font-size wp-elements-10630a1730f608f4a87692793c9f4978">Integrated Solutions. </h2> <h2 class="wp-block-heading is-style-no-margins has-dark-purple-color has-text-color has-link-color has-sxlarge-font-size wp-elements-57aa09ccb9fac95788c9c3e34a03ec92"><strong>Full-Service Support</strong></h2> <p class="is-style-more-margins has-splus-font-size">ELIQUENT’s unprecedented assembly of regulatory leaders, industry experts, and technical specialists collaborate seamlessly to provide a full-service engagement that delivers end-to-end support. No matter your pathway position, regulatory requirements, global market or therapeutic area – <strong>ELIQUENT’s integrated solutions align with your regulatory goals to unlock regulatory success.</strong></p> <div style="height:0px" aria-hidden="true" class="wp-block-spacer"></div>  <div class="progression-block is-style-default"> <div class="outer"> <div class="progs"> <div class="prog-wrap"><div class="prog"><div class="circle"></div><div class="inner1"><div class="inner2"><h3>Regulatory Affairs Solutions</h3></div></div></div></div><div class="prog-wrap"><div class="prog"><div class="circle"></div><div class="inner1"><div class="inner2"><h3>PV+ Postmarket Surveillance</h3></div></div></div></div><div class="prog-wrap"><div class="prog"><div class="circle"></div><div class="inner1"><div class="inner2"><h3>Quality & Compliance</h3></div></div></div></div><div class="prog-wrap"><div class="prog"><div class="circle"></div><div class="inner1"><div class="inner2"><h3>Remediation 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-10 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 & 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’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’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>  <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-11 wp-block-columns-is-layout-flex"> <div class="wp-block-column is-layout-flow wp-block-column-is-layout-flow" style="flex-basis:66.66%"> <div style="height:50px" aria-hidden="true" class="wp-block-spacer"></div> <figure class="wp-block-image size-large"><img decoding="async" width="417" height="61" src="https://eliquent.com/wp-content/uploads/2024/06/iqcentral-1.svg" alt="" class="wp-image-1341"/></figure> </div> <div class="wp-block-column is-layout-flow wp-block-column-is-layout-flow" style="flex-basis:33.33%"></div> </div> <p class="has-splus-font-size"><strong>Your resource for regulatory clarity.</strong></p> <p>IQ Central is your resource for industry insights, expert perspectives, and valuable tools. Here, you’ll find a comprehensive collection of collateral, expert resources, and thought leadership designed to support your goals and keep you informed on the latest trends and help you navigate today’s regulatory landscape.</p>  <div class="resource-icons-block resource-icons-grid" data-columns="3"> <div class="resource-icons expands" data-index="0"> <div class="content-area"> <h3 class="heading-main heading">Resources</h3> <div class="inner"> <img decoding="async" src="https://eliquent.com/wp-content/uploads/2024/10/RESOURCE-Icon-info-sheet.png" alt=""> <div> <h3 class="heading">INFO SHEET: Medical Device Solutions</h3> <p><p>Download ELIQUENT’s information sheet.</p> </p> <a class="cta" href="https://eliquent.com/wp-content/uploads/2024/10/MED-DEVICE-Info-Sheet-2024.11.01.pdf" target="_blank">Info Sheet <span aria-hidden="true">></span></a> </div> </div> <div class=" inner" id="bottom-inner"> <img decoding="async" src="https://eliquent.com/wp-content/uploads/2024/10/RESOURCE-Icon-info-sheet.png" alt=""> <div> <h3 class="heading">INFO SHEET: Regulatory Affairs Solutions</h3> <p><p>Download ELIQUENT’s information sheet.</p> </p> <a class="cta" href="https://eliquent.com/wp-content/uploads/2024/10/REG-AFFAIRS-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">Impact of R&D Quality Systems & Data Integrity in Drug Development</h3> <p><p>Read Steven Bowen, Ph.D.’s article in the <em>Journal of Pharmaceutical Sciences.</em></p> </p> <a class="cta" href="/" target="">Read more <span aria-hidden="true">></span></a> </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: Global Regulatory Solutions</h3> <p><p>Learn how ELIQUENT Japan guided a global immunology company to regulatory success.</p> </p> <a class="cta" href="/" target="">Read more <span aria-hidden="true">></span></a> </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">Regulatory Writing</h3> <p><p>Explore ELIQUENT’s Regulatory & Medical Writing Solutions.</p> </p> <a class="cta" href="/" target="">Regulatory Writing Solutions <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</h3> <p><p>Explore ELIQUENT’s Quality Management System Regulation (QMSR) Solutions.</p> </p> <a class="cta" href="/" target="">QMSR Solutions <span aria-hidden="true">></span></a> </div> </div> </div> </div> </div>  <div class="featured-resources-with-heading-block is-style-default"> <div class="resource-articles"> <h3 class="related-heading"></h3> <div class="resources-grid four-col"> <article id="post-3833" class="featured-resource-with-heading post-3833 resource type-resource status-publish has-post-thumbnail hentry resource_type-blog-article"> <a href="https://eliquent.com/resource/container-closure-system-component-changes-glass-vials-stoppers/" style="background-image:url(https://eliquent.com/wp-content/uploads/2024/11/BLOCK-with-overlay10.svg);"> <div class="post-type">resource</div> <p>IQ Central</p> <h3>Container Closure System & Component Changes – Glass Vials & Stoppers</h3> </a> </article> <article id="post-3836" class="featured-resource-with-heading post-3836 resource type-resource status-publish has-post-thumbnail hentry resource_type-blog-article"> <a href="https://eliquent.com/resource/iq-central-fda-qsr-vs-qmsr-what-medical-device-manufacturers-need-to-know/" style="background-image:url(https://eliquent.com/wp-content/uploads/2024/11/BLOCK-with-overlay8.svg);"> <div class="post-type">resource</div> <p>IQ Central</p> <h3>FDA QSR vs. QMSR: What Medical Device Manufacturers Need to Know</h3> </a> </article> <article id="post-3835" class="featured-resource-with-heading post-3835 resource type-resource status-publish has-post-thumbnail hentry resource_type-webinar resource_type-presentation"> <a href="https://eliquent.com/resource/ldt-regulations-roadmap/" style="background-image:url(https://eliquent.com/wp-content/uploads/2024/11/BLOCK-with-overlay9.svg);"> <div class="post-type">resource</div> <p>IQ Central</p> <h3>ROADMAP: FDA’s New LDT Regulations</h3> </a> </article> <article id="post-4002" class="featured-resource-with-heading post-4002 resource type-resource status-publish has-post-thumbnail hentry resource_type-fact-sheet"> <a href="https://eliquent.com/resource/info-sheet-regulatory-medical-writing/" style="background-image:url(https://eliquent.com/wp-content/uploads/2024/11/BLOCK-with-overlay19.svg);"> <div class="post-type">resource</div> <p>IQ Central</p> <h3>Info Sheet: Regulatory & Medical Writing</h3> </a> </article> </div> </div> </div> </div> </div> </div>  <div class="background-container-block alignfull is-style-no-margins background-none"> <div class="maybe-wrapper"> <div class="acf-innerblocks-container"> <h2 class="wp-block-heading has-text-align-center is-style-no-margins has-dark-purple-color has-text-color">Ready for regulatory clarity? 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'<h' + data.settings.form_title_heading_level + '>' + data.settings.title + '</h' + data.settings.form_title_heading_level + '>' : '' }}} </span> <div class="nf-form-wrap ninja-forms-form-wrap"> <div class="nf-response-msg"></div> <div class="nf-debug-msg"></div> <div class="nf-before-form"></div> <div class="nf-form-layout"></div> <div class="nf-after-form"></div> </div> </script> <script id="tmpl-nf-empty" type="text/template"> </script> <script id="tmpl-nf-before-form" type="text/template"> {{{ data.beforeForm }}} </script><script id="tmpl-nf-after-form" type="text/template"> {{{ data.afterForm }}} </script><script id="tmpl-nf-before-fields" type="text/template"> <div class="nf-form-fields-required">{{{ data.renderFieldsMarkedRequired() }}}</div> {{{ data.beforeFields }}} </script><script id="tmpl-nf-after-fields" type="text/template"> {{{ data.afterFields }}} <div id="nf-form-errors-{{{ data.id }}}" class="nf-form-errors" role="alert"></div> <div class="nf-form-hp"></div> </script> <script id="tmpl-nf-before-field" type="text/template"> {{{ data.beforeField }}} </script><script id="tmpl-nf-after-field" type="text/template"> {{{ data.afterField }}} </script><script id="tmpl-nf-form-layout" type="text/template"> <form> <div> <div class="nf-before-form-content"></div> <div class="nf-form-content {{{ data.element_class }}}"></div> <div class="nf-after-form-content"></div> </div> </form> </script><script id="tmpl-nf-form-hp" type="text/template"> <label id="nf-label-field-hp-{{{ data.id }}}" for="nf-field-hp-{{{ data.id }}}" aria-hidden="true"> {{{ nfi18n.formHoneypot }}} <input id="nf-field-hp-{{{ data.id }}}" name="nf-field-hp" class="nf-element nf-field-hp" type="text" value="" aria-labelledby="nf-label-field-hp-{{{ data.id }}}" /> </label> </script> <script id="tmpl-nf-field-layout" type="text/template"> <div id="nf-field-{{{ data.id }}}-container" class="nf-field-container {{{ data.type }}}-container {{{ data.renderContainerClass() }}}"> <div class="nf-before-field"></div> <div class="nf-field"></div> <div class="nf-after-field"></div> </div> </script> <script id="tmpl-nf-field-before" type="text/template"> {{{ data.beforeField }}} </script><script id="tmpl-nf-field-after" type="text/template"> <# /* * Render our input limit section if that setting exists. */ #> <div class="nf-input-limit"></div> <# /* * Render our error section if we have an error. */ #> <div id="nf-error-{{{ data.id }}}" class="nf-error-wrap nf-error" role="alert"></div> <# /* * Render any custom HTML after our field. */ #> {{{ data.afterField }}} </script> <script id="tmpl-nf-field-wrap" type="text/template"> <div id="nf-field-{{{ data.id }}}-wrap" class="{{{ data.renderWrapClass() }}}" data-field-id="{{{ data.id }}}"> <# /* * This is our main field template. It's called for every field type. * Note that must have ONE top-level, wrapping element. i.e. a div/span/etc that wraps all of the template. */ #> <# /* * Render our label. */ #> {{{ data.renderLabel() }}} <# /* * Render our field element. 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>  <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>