CINXE.COM
Regulatory Affairs
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class="dropdown-item" href="/therapeutics/central-nervous-system">Central Nervous System</a> <a class="dropdown-item" href="/therapeutics/endocrine-metabolic-disorders">Endocrine & Metabolic Disorders</a> <a class="dropdown-item" href="/therapeutics/infectious-diseases">Infectious Diseases</a> <a class="dropdown-item" href="/therapeutics/internal-medicine-immunology">Internal Medicine & Immunology</a> <a class="dropdown-item" href="/therapeutics/oncology">Oncology</a> </div> <div class="col-xl-3"> <div class="mega-menu-title"> <div><span>Cross-therapeutics</span></div> </div> <a href="/therapeutics/biosimilars" class="dropdown-item" data-drupal-link-system-path="node/33807">Biosimilars</a> <a href="/therapeutics/cell-and-gene-therapies" class="dropdown-item" data-drupal-link-system-path="node/34067">Cell and Gene Therapies</a> <a href="/therapeutics/medical-device" class="dropdown-item" data-drupal-link-system-path="node/34085">Medical Device</a> <a href="/therapeutics/pediatrics" 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appropriate obesity-specific trial designs, long-term follow-up studies and diverse patient recruitment.</p> </a> </div> <div class="col-xl-3"> <a href="/insights/therapeutics" class="dropdown-item dropdown-item--with-image"> <div class="image image--zoom-on-hover"> <div><div><img src="https://icon.widen.net/content/78559377-8cc3-4bc6-b6f2-cc20a04e1504/web/cells-menu-hero.jpg?crop=yes&w=260&h=136&itok=0ESOS9pw" width="260" height="136" alt="cells-menu-hero.jpg" loading="eager" title="cells-menu-hero.jpg" /> </div> </div> </div> <span class="h4">Therapeutics insights</span> <p class="section-overview--desktop">ICON's therapeutic experts contribute regularly to industry publications and the creation of thought leadership content. Read more. </p> </a> </div> </div> </div> </div> </li> <li class="nav-item dropdown"> <a href="/insights" aria-expanded="false" class="nav-link dropdown-toggle" data-toggle="dropdown" role="button"> Insights <span></span> </a> <div class="menu_link_content menu-link-contentmain view-mode-main-navigation dropdown-menu"> <button class="navbar-btn navbar-btn--back" type="button"> <span class="navbar-btn__icon"></span> </button> <div class="container-fluid container-fluid--xl"> <div class="row"> <div class="col-xl-3"> <div class="paragraph paragraph--type--mega-menu-text paragraph--view-mode--default"> <div class="mega-menu-title"><a href="/insights" target="_self">Insights</a></div> </div> <a class="dropdown-item" href="/insights/digital-disruption">Digital Disruption</a> <a class="dropdown-item" href="/insights/patient-centricity">Patient Centricity</a> <a class="dropdown-item" href="/insights/regulatory-intelligence">Regulatory Intelligence</a> <a class="dropdown-item" 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We understand the nuances surrounding global regulatory requirements and development pathways, as well as the factors that may influence the product’s journey from gap analysis through to market approval.</p></div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="b90b8934-c52d-4fbe-8d8c-70516781693e" class="icon-group icon-group--horizontal"> <div class="container-fluid container-fluid--xl"> <h2 class="icon-group__title">Helping clients navigate complex global regulatory requirements and emerging issues</h2> <ul class="icon-group__items icon-group__items__columns-4"> <li class="icon-group__item--blue"> <div lang="en" class="icon-group__wrapper" > <i class="icon-client"></i> <p class="mb-2 icons-large-text">35+</p> <small>Years of consulting experience</small> </div> </li> <li class="icon-group__item--green"> <div lang="en" class="icon-group__wrapper" > <i class="icon-consulting"></i> <p class="mb-2 icons-large-text">1000+</p> <small>Regulatory consultants</small> </div> </li> <li class="icon-group__item--yellow-green"> <div lang="en" class="icon-group__wrapper" > <i class="icon-report"></i> <p class="mb-2 icons-large-text">900+</p> <small>Projects</small> </div> </li> <li class="icon-group__item--purple"> <div lang="en" class="icon-group__wrapper" > <i class="icon-global"></i> <p class="mb-2 icons-large-text">100+</p> <small>Countries</small> </div> </li> </ul> </div> </div> <div id="6065ff5b-b484-41c4-9d7c-d561fd8ce47c"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture-wrapper"> <div class="text-picture text-picture--text-only text-left with-separator--top"> <div> <div class="text-picture__text"> <h2>Delivering sound regulatory strategies and operational support for drug and device development</h2> <h3> </h3> <div><p><span lang="EN-GB">Our mission<strong> </strong>is to deliver customised, end-to-end regulatory solutions with a diverse team of industry recognised consultants who provide best-in-class support to our clients.<o:p></o:p></span></p><p><span lang="EN-GB">ICON’s Regulatory Consulting Solutions team are leaders in the complex regulatory environment, having built their expertise within the biotech and pharma industries. <o:p></o:p></span></p><p><span lang="EN-GB">We provide a full suite of regulatory solutions in key markets globally. Our extensive experience with the FDA, European, PMDA and international regulatory authorities allow us to deliver strategic and operational support to expedite your drug and device development programs across the entire product lifecycle.<o:p></o:p></span></p></div> </div> </div> </div> </div> </div> </div> </div> </div><div id="ef0be2b1-4beb-49b1-ae20-b94307ad0381"> <div class="group "> <div class="container-fluid container-fluid--xl"> <div class="row "> <div class="col-sm"> <div class="container-full"> <div class="card card--title-description card--title-description-green "> <div class="card-body" data-mh="card-body"> <i class="icon-ui-arrow-right"></i> <h4 class="card-title">Strategic and operational consulting</h4> <div class="card-text small"> <div><p>Deliver regulatory strategic consulting across the product life cycle, offering practical solutions and guidance to expedite product registration.</p></div> </div> </div> </div> </div> </div> <div class="col-sm"> <div class="container-full"> <div class="card card--title-description card--title-description-purple "> <div class="card-body" data-mh="card-body"> <i class="icon-ui-arrow-right"></i> <h4 class="card-title">End-to-end regulatory expertise</h4> <div class="card-text small"> <div><p>Offer end-to-end regulatory services guiding our clients through the complex regulatory landscape and bring safe and compliant products to market.</p></div> </div> </div> </div> </div> </div> <div class="col-sm"> <div class="container-full"> <div class="card card--title-description card--title-description-blue "> <div class="card-body" data-mh="card-body"> <i class="icon-ui-arrow-right"></i> <h4 class="card-title">Strong global presence</h4> <div class="card-text small"> <div><p>Our global reach helps navigate diverse regulatory environments, adapt to local requirements and provide seamless support to clients regardless of location.</p></div> </div> </div> </div> </div> </div> <div class="col-sm"> <div class="container-full"> <div class="card card--title-description card--title-description-yellow-green "> <div class="card-body" data-mh="card-body"> <i class="icon-ui-arrow-right"></i> <h4 class="card-title">Flexible resourcing models</h4> <div class="card-text small"> <div><p>Provide customised regulatory support through working models such as in-house placement or consulting hours, tailored to meet client requirements.</p></div> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="f0f2c12b-2963-4f3c-834e-1896f8242248"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture-wrapper"> <div class="text-picture text-picture--text-only text-left with-separator--top"> <div> <div class="text-picture__text"> <h2>Your flexible service regulatory partner</h2> <h3> </h3> <div><p>Regulatory Consulting Solutions consists of 7 key functions (outlined below), with 50+ service capabilities that can be offered to clients as standalone, or bundled services.</p></div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="f1e3355b-5f27-45e8-90be-8b278c88640a"> <div class="group transparent area-wrapper"> <div class="container-fluid container-fluid--xl"> <h2 class="group__title"> Regulatory Consulting Solutions </h2> <div class="area area--nav-left"> <ul class="area__nav area__nav--green"> <li> <a href="/solutions/consulting/regulatory-affairs/project-services" class="area__nav-item active has-link" target="_self" data-target="#area-item-0-149266-142241"> <span class="area__nav-title">Regulatory Project Services</span> <span class="area__nav-description">We provide regulatory project management and submission management services with demonstrated success, facilitating delivery of timely and compliant dossiers worldwide.</span> </a> </li> <li> <a href="/solutions/consulting/regulatory-affairs/regulatory-strategy" class="area__nav-item has-link" target="_self" data-target="#area-item-1-149266-142246"> <span class="area__nav-title">Global Regulatory Strategy</span> <span class="area__nav-description">ICON offers full-service development and regulatory consultancy, providing both strategic and operational support throughout the product development life cycle, covering preclinical/analytical and clinical trial evaluation, marketing authorisation and post-approval maintenance.</span> </a> </li> <li> <a href="/solutions/consulting/regulatory-affairs/cmc-services" class="area__nav-item has-link" target="_self" data-target="#area-item-2-149266-142251"> <span class="area__nav-title">CMC and Quality</span> <span class="area__nav-description">The ICON Chemistry, Manufacturing & Controls and Quality team provides sound CMC strategies that are executed by industry-leading experts.</span> </a> </li> <li> <a href="/solutions/consulting/regulatory-affairs/regulatory-operations" class="area__nav-item has-link" target="_self" data-target="#area-item-3-149266-142256"> <span class="area__nav-title">Regulatory Operations</span> <span class="area__nav-description">ICON provides a full range of regulatory submission publishing services, including document formatting, submission readiness, report-level publishing, eCTD/ NeeS/ paper publishing, quality control, dispatch and archival submissions.</span> </a> </li> <li> <a href="/solutions/consulting/regulatory-affairs/global-labelling-and-ad-promotion" class="area__nav-item has-link" target="_self" data-target="#area-item-4-149266-142261"> <span class="area__nav-title">Global Labelling and Ad Promo</span> <span class="area__nav-description">ICON global labelling and ad promotion supports all stages of product development, maintenance and operations.</span> </a> </li> <li> <a href="/solutions/consulting/regulatory-affairs/medical-devices-ivd" class="area__nav-item has-link" target="_self" data-target="#area-item-5-149266-143056"> <span class="area__nav-title">Regulatory Affairs Medical Devices & IVD</span> <span class="area__nav-description">Our medical device & IVD regulatory experts can help you gain a deep understanding of the applicable regulations and requirements, often beyond what is available in published guidance documents and other materials.</span> </a> </li> <li> <a href="/solutions/consulting/regulatory-affairs/regulatory-affairs-clinical-support" class="area__nav-item has-link" target="_self" data-target="#area-item-6-149266-142271"> <span class="area__nav-title">Clinical Trial – Global Regulatory Affairs</span> <span class="area__nav-description">Our regulatory teams will work with you to create a strategy early in development to identify key challenges that may arise and to interact collaboratively with regulatory authorities.</span> </a> </li> </ul> <div class="area__content"> <a data-responsive-backgrounds="true" 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