A Faster Way to Complete Global Regulatory Submissions

Choose consulting and content solutions that help you clear regulatory hurdles and demonstrate product safety and effectiveness.

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Solutions That Expedite Regulatory Submissions

Content translation for regulatory submissions can shift deadlines, slow cycle times, and delay product releases. Find solutions for expediting submissions in a safe, timely, and cost-effective way.

    Product Information Translations

    Mitigate risk of human error in label production with labeling management technology that creates savings of up to 40% in translation and project management costs of global submissions (including centralized procedures in Europe, dossiers in Latin America or Asia, and Health Canada submissions).

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    Medical Writing

    Deliver first-class medical writing with analysis, creation, translation, and SME support for your regulatory documentation. Know your content is clear, concise, and follows global regulations.

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    Regulatory Translation Management

    Manage the translation of regulatory documents within one AI-powered ecosystem, integrated with Veeva and other RIMs, to ensure compliance and facilitate market access and approval.

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    eCTD Support

    Seamlessly integrate translated regulatory documents into electronic Common Technical Document (eCTD) format for efficient submission and review.

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    Navigate the Complexity of Global Regulatory Submissions

    TransPerfect helps regulatory departments reduce filing timelines and avoid critical errors and regulatory roadblocks. TransPerfect's word and phrase database generates savings by eliminating duplicate translations, which shortens overall timelines. With offices in over 100 cities and a worldwide network of experts specifically trained in mitigating risks associated with terminology and template non-compliance, there is no better partner to support your regulatory and labeling requirements than TransPerfect Life Sciences.

    Streamlined Regulatory Submissions by the Numbers

    40 %

    Savings in translation and project management costs

    140 +

    Offices in major cities

    125 k

    Global clinical studies supported

    30 +

    Years of experience

    Ready to mitigate the obstacles from global regulatory submissions?

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    Regulatory Translation Solution Saves $1.1M for Global Pharma Company

    regulatory writing

    TransPerfect Life Sciences centralizes and integrates regulatory affairs global translations with GlobalLink and Veeva RIM.

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    News and Thought Leadership

    Our industry experts have in-depth understanding of the challenges, requirements, and goals for life sciences organizations.

    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. The two discuss why keeping a rigorous measure is often harder than building it in the first place, walk through why studies still run on out-of-date versions and translations, and reflect on ...

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

    SSCPs Are Not Labeling: Compliant AI Processes for Reduced Cost & Turnaround

    In this fireside chat, TransPerfect Medical Device's President Marc Miller sits down with Dr. Keith Morel, VP of Regulatory Compliance at Qserve, to unpack a critical question facing medical device manufacturers under MDR: can you reduce the translation review process for ...
    Success Stories

    Top 10 Pharma Company Overhauls Global COA Program,Cutting Costs by 33% and Errors to Near Zero

    Inconsistent standards, stretched timelines, and limited visibility were straining a top 10 pharma company's COA program. Discover how TransPerfect Life Sciences' centralization strategy delivered 99.7% accuracy, 40% less PM oversight, and 33% cost savings across the ...
    Blog

    Four Years In: What the EU Clinical Trial Regulation Has (and Hasn't) Delivered

    When the EU Clinical Trial Regulation (EU CTR No 536/2014) went live for new submissions on January 31, 2022, it promised to transform how clinical trials are authorized and conducted across Europe: a single submission, one decision, and harmonized oversight. Four years in,...
    Webinar

    How to Make Your Academy Succeed at Global Scale—Lessons Learned on What Works and What Doesn’t

    Most life sciences and MedTech companies launch a corporate academy with strong strategic intent, whether that’s executive sponsorship, a named platform, a dedicated budget, or a curriculum mapped to business goals. After launch, however, these same organizations all too often ...