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.

    The 5-Step AI Readiness Checklist for Medical Device Manufacturers

    Only one in four manufacturers using process AI say it's meeting expectations. The gap between those results and the rest comes down to preparation. This checklist is built from patterns shared by manufacturers that are seeing results, along with the gaps most commonly found among those that aren't. ...

    The 5-Step AI Readiness Checklist for Medical Device Manufacturers
    Webinar

    XTalks | How MI, PV & Regulatory Collaborate on Signals, Labeling, Crisis Response and AI

    Medical Information (MI), Pharmacovigilance (PV) and Regulatory Affairs (RA) each play distinct but deeply interconnected roles in ensuring that therapeutics are safe, accurately labeled and compliantly communicated to healthcare professionals and patients. Yet in practice, the ...
    Event

    C3 Summit 2026 - San Francisco

    Conversations on Clinical Content, C3 Summit is part of a series of events hosted by TransPerfect Life Sciences featuring sessions with expert panels discussing present challenges, strategies, and innovations, as well as insights into future advancements, from R&D to ...
    Webinar

    LifeSci Talks COA Series | Nothing Remains the Same: Why Measures Have to Evolve

    In this episode of LifeSci Talks, Mark Wade, Global Practice Leader at TransPerfect Life Sciences, sits down with RJ Wirth, CEO and Consulting Psychometrician at Vector Psychometric Group, to talk about why the measures we rely on are living things rather than fixed artifacts. ...
    Blog

    Regulatory Considerations for Paper COA Translations | What You Need to Know

    Collecting data for a global clinical trial on paper COAs or managing a mixed-mode study that combines both paper and electronic formats means satisfying multiple regulatory bodies before a single patient enrolls. None of these entities operate on the same timeline or...
    Blog

    When "How Does the Patient Feel?" Became a Regulatory Question

    For decades, clinical trials were built around things you could measure with a machine: tumor shrinkage on a scan, laboratory values, and disease progression. These hard, objective endpoints were the backbone of drug approval. The patient's own account of how they felt,...
    Webinar

    XTalks | eCOA: Has It Lived Up to the Promise? A Realistic Assessment for Today's Trials

    Despite two decades of technological advancement, the debate between paper and electronic clinical outcome assessments (eCOA) remains unresolved. This webinar revisits the assumptions that continue to shape data collection strategies and examines whether current practice reflects ...