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.

    LifeSci Talks COA Series | Are We Sacrificing Good for Perfect in Clinical Outcome Assessment?

    In this episode of LifeSci Talks, Mark Wade, Global Practice Leader at TransPerfect Life Sciences, sits down with Stacie Hudgens, Chief Scientific and Strategy Officer at Clinical Outcome Solutions, to discuss whether the field of clinical outcome assessment has started sacrificing “good for perfect.” Together, they explore the role of regulatory guidance and clinical development timelines, specifically the role of measurement science in already tight development ...

    LifeSci Talks COA Series | Are We Sacrificing Good for Perfect in Clinical Outcome Assessment?
    Event

    C3 Summit 2025 - London

    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 ...
    White Paper

    Libraries in Clinical Outcome Assessments: How Valuable Are They—and Are They the Panacea They’re Claimed to Be?

    Speed, cost, and quality are competing priorities in eCOA localization. Discover why translation libraries alone aren't enough, and what combination of proactive licensing, automation, and integrated technology can transform your deployment timelines. ...
    Blog

    From Reactive to Strategic: How AI Is Transforming Medical Information Contact Centers

    IntroductionFor decades, Medical Information (MI) has been an essential function within pharma, but largely a reactive one. This is especially true in medical information contact centers, which serve as the first line of support for HCPs and patients. When someone has a...
    Blog

    Is AI Ready to Transform COA Development?

    AI is reshaping clinical development, but its greatest value may lie not in replacing human expertise, but rather in augmenting it. Across the drug development pipeline, AI is helping teams analyze vast datasets faster, identify promising compounds earlier, and uncover...
    Blog

    Five Domains the FDA Wants You to Measure in PROs for Cancer—and Why Translation Affects All of Them

    In a recent "LifeSci Talks" episode, TransPerfect Global Practice Leader Mark Wade and Signant Health VP and eCOA Scientist Bill Byrom PhD discussed how new FDA guidance is reshaping how sponsors approach patient-reported outcomes (PROs) in cancer clinical trials. PROs...
    Webinar

    AI in Medical Information: Challenges, Opportunities, and the Path to Compliant Content at Scale

    Medical information teams are being asked to do more with less; faster turnaround, broader content demands, and zero tolerance for inaccuracy. AI offers a way forward, but adoption comes with real challenges: how do you validate accuracy, integrate literature review, and build ...