Empowering Regulatory Teams with Global Content Solutions

Regulatory professionals have to keep pace with the ever-evolving landscape of global regulations to ensure compliance, mitigate risk, and avoid costly delays.

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Why Regulatory Teams Love TransPerfect

Our 30+ years of knowledge and experience in Regulatory Affairs allows us to create and curate strategic risk-based solutions to improve compliance, simplify submissions, and avoid post-market pitfalls. Here are some of your options:


    Medical Writing

    Simplify content creation for a range of regulatory document types, including eCTD preparation and publishing.

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    Regulatory Consulting

    Create a roadmap to navigate complex regulatory requirements through TransPerfect’s network of regulatory expertise in 100+ countries, to ensure compliance to current and ever-changing regulations.

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    Translation

    We employ certified linguists, state-of-the-art…management technology to address the needs and challenges associated with the development process while following regulatory guidelines.

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    Workflow Management Technology

    Streamline the management of translations for submissions using an AI-powered platform to drive workflow automation, lock previously approved content, and facilitate online review and approval in any language.

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    Regulatory Documents and Submissions Powered by Trial Interactive

    Author regulatory documents, review, approve, and manage submissions in a single 21 CFR Part 11-compliant platform.

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    Your Partner in Navigating Global Regulations and Submissions

    Get strategic global regulatory support throughout the product development life cycle from pre-clinical through clinical trials to marketing authorization and commercialization.

    Trusted by Life Sciences Organizations Big and Small

    Talk to Our Global Regulatory Experts.

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    News and Thought Leadership

    Industry insights from our experts. We have the experience and solutions you need to navigate life sciences complexity and bring breakthroughs from lab to launch.

    5 Common eCOA Migration Issues

    Blog

    With so many clinical trials now using COAs on electronic platforms, the practice of “migration” (transferring and adapting COAs for electronic use) has become more common than ever. Without careful implementation, one minor deviation can compound across many languages, leading to delays in FPFV or, if not caught prior to deployment, data integrity issues. If these types of issues are discovered and corrected before the translation process begins, it can prevent the ...

    5 Common eCOA Migration Issues
    Success Stories

    Fortune 500 Pharma Company Meets Critical Deadlines with TransPerfect Life Sciences’ COA Solutions

    This spotlight reviews the challenges faced by a Fortune 500 pharmaceutical company in implementing Clinical Outcome Assessments (COAs) to measure the impact of their products on patients. It discusses the need for accurate and culturally appropriate translations of COAs for ...
    White Paper

    Successful English Build & Language Migration

    Over the past decade, the global clinical trial landscape has changed drastically. A surge in technological innovation, including wearable devices, patient portals, and apps, has modernized how clinical data is collected and managed. With pen and paper becoming obsolete in the ...
    Blog

    Why 75% of Medical Device Manufacturers Are Disappointed with Their AI Results

    The Gap "The results we're seeing from AI are only as good as the data and structure we put behind it. Most manufacturers haven't done that work yet." — Marc Miller, Division President, TransPerfect Medical DeviceArtificial intelligence has arrived in medical device...
    Blog

    Metadata In, Metadata Out: Reducing RIM Submission Rework with In-System Translation

    Pharmaceutical companies spend billions and take years to bring therapies to market. Then many risk it all on a translation process managed with spreadsheets, email chains, and blind faith. Every label update, every safety amendment, every regulatory change notice must be...
    Blog

    AI Content Creation and Maintenance in Medical Information: Ending the Content Whack-a-Mole

    For many medical information (MI) teams, content maintenance can often feel like a game of whack-a-mole.Update one answer, three more pop up. Fix a regional version, and another channel drifts out of sync. Add a new piece of literature, and suddenly every approved response...
    Guide

    The Global Patient Recruitment Toolkit

    Everything you need to recruit and retain patients across borders, from localization checklists to real-world case studies, in one place. Inside, you'll find audit-ready frameworks, proven recruitment strategies, and firsthand accounts of how a top 10 pharma leader expanded ...