Pharma Regulatory Affairs, Clinical Regulatory Consulting

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id="mobile_menu" class="mobile-menu"><li id="menu-item-3342" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-has-children menu-item-3342"><a href="#">About tranScrip</a> <ul class="sub-menu"> <li id="menu-item-2756" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-2756"><a href="https://transcrip-group.com/about-us/">About Us</a></li> <li id="menu-item-2758" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-2758"><a href="https://transcrip-group.com/our-people/">Our People</a></li> <li id="menu-item-2757" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-2757"><a href="https://transcrip-group.com/about-us/our-social-responsibility/">Our Social Responsibility</a></li> </ul> </li> <li id="menu-item-2754" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-2754"><a href="https://transcrip-group.com/services/">Services</a></li> <li id="menu-item-2755" class="menu-item 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<?xml version="1.0" encoding="UTF-8"?><svg id="Layer_1" xmlns="http://www.w3.org/2000/svg" viewBox="0 0 400 400"><defs><style>.cls-1{fill:#007f7e;}.cls-1,.cls-2,.cls-3,.cls-4{stroke-width:0px;}.cls-2{fill:#4e367c;}.cls-3{fill:#a9ade7;}.cls-4{fill:#fff;}</style></defs><circle class="cls-4" cx="200" cy="200" r="198.42"/><path class="cls-2" d="M285.61,340H114.39c-10.39,0-18.85-8.46-18.85-18.86V100.17c0-10.39,8.46-18.85,18.85-18.85h21.64c2.74,0,4.96,2.22,4.96,4.96s-2.22,4.96-4.96,4.96h-21.64c-4.92,0-8.93,4-8.93,8.93v220.97c0,4.93,4,8.93,8.93,8.93h171.23c4.92,0,8.93-4.01,8.93-8.93V100.17c0-4.92-4-8.93-8.93-8.93h-21.64c-2.74,0-4.96-2.22-4.96-4.96s2.22-4.96,4.96-4.96h21.64c10.39,0,18.85,8.46,18.85,18.85v220.97c0,10.4-8.46,18.86-18.85,18.86ZM242.64,98.35h-85.29c-2.74,0-4.96-2.22-4.96-4.96v-22.04c0-6.26,5.09-11.35,11.34-11.35h72.52c6.25,0,11.34,5.09,11.34,11.35v21.78c0,.09,0,.18,0,.26,0,2.74-2.22,4.96-4.96,4.96ZM162.32,88.43h75.35v-17.08c0-.79-.64-1.42-1.42-1.42h-72.52c-.78,0-1.42.64-1.42,1.42v17.08Z"/><path class="cls-1" d="M144.85,158.95s-.08,0-.12,0c-1.36-.03-2.64-.62-3.56-1.63l-9.85-10.88c-1.84-2.03-1.68-5.17.35-7.01,2.03-1.84,5.17-1.68,7.01.35l6.35,7.01,15.13-15.14c1.94-1.94,5.08-1.94,7.02,0,1.94,1.94,1.94,5.08,0,7.02l-18.82,18.83c-.93.93-2.2,1.45-3.51,1.45Z"/><path class="cls-1" d="M164.46,297.35h-35.53c-2.74,0-4.96-2.22-4.96-4.96v-28.43c0-2.74,2.22-4.96,4.96-4.96h35.53c2.74,0,4.96,2.22,4.96,4.96v28.43c0,2.74-2.22,4.96-4.96,4.96ZM133.89,287.42h25.61v-18.5h-25.61v18.5ZM164.46,233.39h-35.53c-2.74,0-4.96-2.22-4.96-4.96v-28.43c0-2.74,2.22-4.96,4.96-4.96h35.53c2.74,0,4.96,2.22,4.96,4.96v28.43c0,2.74-2.22,4.96-4.96,4.96ZM133.89,223.46h25.61v-18.5h-25.61v18.5Z"/><path class="cls-3" d="M249.75,169.43h-56.86c-2.74,0-4.96-2.22-4.96-4.96s2.22-4.96,4.96-4.96h56.86c2.74,0,4.96,2.22,4.96,4.96s-2.22,4.96-4.96,4.96Z"/><path class="cls-3" d="M249.75,233.39h-56.86c-2.74,0-4.96-2.22-4.96-4.96s2.22-4.96,4.96-4.96h56.86c2.74,0,4.96,2.22,4.96,4.96s-2.22,4.96-4.96,4.96Z"/><path class="cls-3" d="M271.07,268.92h-78.18c-2.74,0-4.96-2.22-4.96-4.96s2.22-4.96,4.96-4.96h78.18c2.74,0,4.96,2.22,4.96,4.96s-2.22,4.96-4.96,4.96Z"/><path class="cls-3" d="M242.64,297.35h-49.75c-2.74,0-4.96-2.22-4.96-4.96s2.22-4.96,4.96-4.96h49.75c2.74,0,4.96,2.22,4.96,4.96s-2.22,4.96-4.96,4.96Z"/><path class="cls-3" d="M271.07,140.99h-78.18c-2.74,0-4.96-2.22-4.96-4.96s2.22-4.96,4.96-4.96h78.18c2.74,0,4.96,2.22,4.96,4.96s-2.22,4.96-4.96,4.96Z"/><path class="cls-3" d="M271.07,204.96h-78.18c-2.74,0-4.96-2.22-4.96-4.96s2.22-4.96,4.96-4.96h78.18c2.74,0,4.96,2.22,4.96,4.96s-2.22,4.96-4.96,4.96Z"/></svg> </div> <div class="col-12 col-lg-10 service--heroinner-text"> <p class="text-23 leading-relaxed colour-mid-purple font-semibold">Our regulatory team at tranScrip offers comprehensive solutions to ensure successful agency dialogue, meticulous regulatory strategy planning, and timely submissions and approvals. Whatever your regulatory needs, we're here to help.</p> </div> </div> </div> </div> </section><section class="text-and-image bg-purple-teal image-left"> <div class="container relative"> <div class="row justify-content-between align-items-center"> <div class="col-12 col-md-4 text-and-image-image-wrapper"> <picture> <source media="print" srcset="https://transcrip-group.com/content/uploads/2024/08/Strategic-and-Operational.png"> <source media="(min-width: 1500px)" srcset="https://transcrip-group.com/content/uploads/2024/08/Strategic-and-Operational.png"> <source media="(min-width: 1200px)" srcset="https://transcrip-group.com/content/uploads/2024/08/Strategic-and-Operational.png"> <source media="(min-width: 768px)" srcset="https://transcrip-group.com/content/uploads/2024/08/Strategic-and-Operational-740x595.png"> <source media="(min-width: 576px)" srcset="https://transcrip-group.com/content/uploads/2024/08/Strategic-and-Operational-540x540.png"> <img class="img-responsive img-fluid" src="https://transcrip-group.com/content/uploads/2024/08/Strategic-and-Operational-540x540.png" alt="Strategic Expertise"> </picture> </div> <div class="col-12 col-md-8 text-and-image-content-wrapper"> <div class="row text-and-image-title-row"> <div class="col text-and-image-title"> <h2>Strategic Expertise</h2> <h2 style="color:#007F7E;" class="subtitle">Operational Excellence</h2> </div> </div> <div class="row text-and-image-content-row ml-5"> <div class="col text-and-image-content"> <p>In the dynamic world of drug development, understanding and adapting to ever-changing regulatory demands is crucial. At tranScrip, our regulatory experts leverage their intimate knowledge of global and local regulations to provide our clients with effective support.</p> <p>We approach every project holistically, specialising in regulatory affairs, quality systems, and compliance for a variety of products, including New Chemical Entities (NCEs), known drug substances, medical devices, in-vitro diagnostics, and drug-device combinations. Our team is proficient in handling both small molecule and large molecule biologics, including advanced therapy products that incorporate specialist delivery platforms or companion diagnostics.</p> <p>Our dedicated experts are here to support and advise you on meeting your regulatory obligations. From maximising the outputs of your stakeholder agency dialogues to smoothing your product鈥檚 assessment journey, our specialists are on your side.</p> </div> </div> </div> </div> </div> </section> <section class="accordion"> <div class="container"> <div class="row accordion-content-wrapper-row"> <div class="col-12 col-lg-8 accordion-content-wrapper"> <div class="row accordion-title-row"> <div class="col accordion-title"> <h2>Explore our comprehensive services</h2> </div> </div> <div class="row accordion-intro-row"> <div class="col accordion-intro"> <p>Maximise the value of your products with our bespoke solutions.</p> </div> </div> </div> </div> <div class="row accordion--list-wrapper-row"> <div class="col-12 accordion--list-wrapper"> <div class="accordion--item"> <h3 class="relative accordion--item-title">Regulatory Strategy and Maximising Agency Dialogue<span class="accordion--item-icon"></span></h3> <div class="accordion--item-content"> <div class="accordion--item-content-inner wysiwyg-content"> <p>We help you develop and optimise your regulatory strategy, ensuring effective communication with regulatory agencies throughout the development process.</p> </div> </div> </div> <div class="accordion--item"> <h3 class="relative accordion--item-title">Oversight of Clinical Trials or Investigations<span class="accordion--item-icon"></span></h3> <div class="accordion--item-content"> <div class="accordion--item-content-inner wysiwyg-content"> <p>Our team provides comprehensive oversight for your clinical trials or clinical investigations, ensuring regulatory compliance at every stage.</p> </div> </div> </div> <div class="accordion--item"> <h3 class="relative accordion--item-title">Technical Input and Authoring of Regulatory Documentation<span class="accordion--item-icon"></span></h3> <div class="accordion--item-content"> <div class="accordion--item-content-inner wysiwyg-content"> <p>We provide expert technical input and author regulatory documents for medicines, medical devices, and combination products.</p> </div> </div> </div> <div class="accordion--item"> <h3 class="relative accordion--item-title">Incorporating Device or Drug Delivery Platforms and Companion Diagnostics<span class="accordion--item-icon"></span></h3> <div class="accordion--item-content"> <div class="accordion--item-content-inner wysiwyg-content"> <p>We assist in integrating advanced delivery platforms and companion diagnostics into your product development process.</p> </div> </div> </div> <div class="accordion--item"> <h3 class="relative accordion--item-title">Managing Regulatory Submission Processes<span class="accordion--item-icon"></span></h3> <div class="accordion--item-content"> <div class="accordion--item-content-inner wysiwyg-content"> <p>Our team manages the entire regulatory submission process, ensuring timely and accurate submissions.</p> </div> </div> </div> <div class="accordion--item"> <h3 class="relative accordion--item-title">Maintaining Regulatory Compliance and Quality Systems<span class="accordion--item-icon"></span></h3> <div class="accordion--item-content"> <div class="accordion--item-content-inner wysiwyg-content"> <p>We help you maintain compliance with all regulatory requirements and ensure your quality systems are robust and effective.</p> </div> </div> </div> <div class="accordion--item"> <h3 class="relative accordion--item-title">Support with Agency Audits<span class="accordion--item-icon"></span></h3> <div class="accordion--item-content"> <div class="accordion--item-content-inner wysiwyg-content"> <p>We provide support during agency audits, helping you navigate and comply with regulatory scrutiny.</p> </div> </div> </div> </div> </div> </div> </section> <section class="text-and-image bg-purple-teal image-right"> <div class="container relative"> <div class="row justify-content-between align-items-center flex-row-reverse"> <div class="col-12 col-md-4 text-and-image-image-wrapper"> <picture> <source media="print" srcset="https://transcrip-group.com/content/uploads/2024/08/Partnership.png"> <source media="(min-width: 1500px)" srcset="https://transcrip-group.com/content/uploads/2024/08/Partnership.png"> <source media="(min-width: 1200px)" srcset="https://transcrip-group.com/content/uploads/2024/08/Partnership.png"> <source media="(min-width: 768px)" srcset="https://transcrip-group.com/content/uploads/2024/08/Partnership-740x595.png"> <source media="(min-width: 576px)" srcset="https://transcrip-group.com/content/uploads/2024/08/Partnership-540x540.png"> <img class="img-responsive img-fluid" src="https://transcrip-group.com/content/uploads/2024/08/Partnership-540x540.png" alt="Perfectly positioned"> </picture> </div> <div class="col-12 col-md-8 text-and-image-content-wrapper"> <div class="row text-and-image-title-row"> <div class="col text-and-image-title"> <h2>Perfectly positioned</h2> <h2 style="color:#007F7E;" class="subtitle">for a unique partnership</h2> </div> </div> <div class="row text-and-image-content-row ml-5"> <div class="col text-and-image-content"> <p>Our Regulatory Affairs team is equipped to help you achieve successful regulatory submissions and approvals, whether it鈥檚 for a first-in-man study, a new product application, a renewal, or a label extension.</p> <p>With a wealth of industry experience and a proven track record, we deliver exceptional results consistently. We seamlessly integrate with our clients as an extension of their team offering flexible, bespoke resources swiftly to adapt to evolving needs.</p> <p> </p> </div> </div> </div> </div> </div> </section><section class="resource bg-white-pills-left"> <div class="display-resource"> <div class="container"> <div class="row justify-content-between pt-5"> <div class="col-md-6 mb-5"> <h1 class="font-semibold colour-primary text-33 leading-normal mb-3">Case Study</h1> <div class="row no-gutters p-1"> <div class="col-md-6 p-md-5 p-3" style="background-color:#fff;"> <h3 class="mb-5 font-semibold">Regulatory Success for a US-Based Gene Therapy Company in the EU</h3> <a href="https://transcrip-group.com/content/uploads/2024/07/Regulatory-Success-for-a-US-Based-Gene-Therapy-Company-in-the-EU.pdf"><p class="btn btn-dark-green">Read more</p></a> </div> <div class="col-md-6"> <img src="https://transcrip-group.com/content/uploads/2024/07/Regulatory-Success-for-a-US-Based-Gene-Therapy-Company-in-the-EU.png" class="img-fluid"/> </div> </div> </div> <div class="col-md-6 mb-5"> <h1 class="font-semibold colour-primary text-33 leading-normal mb-3">Brochure</h1> <div class="row no-gutters p-1"> <div class="col-md-6 p-md-5 p-3" style="background-color:#fff;"> <h3 class="mb-5 font-semibold">Overview Flyer</h3> <a href="https://transcrip-group.com/content/uploads/2024/08/tranScrip-Overview.pdf"><p class="btn btn-dark-green">Read more</p></a> </div> <div class="col-md-6"> <img src="https://transcrip-group.com/content/uploads/2024/07/overview-brochure-cover.png" class="img-fluid"/> </div> </div> </div> </div> </div> </div> </section> <section class="global-call-to-action bg-dark-green" > <div class="container"> <div class="row global-call-to-action-title-row"> <div class="col-12 global-call-to-action-title"> <h2>Contact Us</h2> </div> </div> <div class="row global-call-to-action-content-row"> <div class="col-12 col-md-8 col-lg-9 global-call-to-action-content"> <p>Our experienced physicians and scientists, together with our regulatory, clinical and commercial experts can support you to maximise the value of your products. 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