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.

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

    Blog

    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, the reality is more nuanced. The regulatory landscape, meanwhile, is moving faster than ever. In a recent Xtalks webinar, four subject matter experts with direct experience navigating CTR and ...

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

    IMP Labeling Workflows That Reduce Relabeling Risk and Start-Up Delays

    Investigational medicinal product (IMP) labeling sits at the heart of clinical trial supply, impacting departments across pharmaceutical organizations, from clinical operations and regulatory affairs to quality assurance and beyond. When labeling activities are managed across ...
    Webinar

    The Missing Link: Why Study Design Makes or Breaks a Clinical Trial

    In this episode of LifeSci Talks, Mark Wade, Global Practice Leader at TransPerfect Life Sciences, sits down with Farrell Healion, Founder and Principal Consultant at OptiTrial, to explore why study design is so often the overlooked "missing link" in clinical ...
    Event

    C3 Summit 2026 - 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 ...
    Blog

    Considerations for eCOA in Global Clinical Trials

    Regulatory Considerations for eCOA Submissions in Global Clinical Trials: What You Need to KnowWhen managing eCOA in clinical trials across multiple countries, translation, linguistic validation, and electronic implementation of Clinical Outcome Assessments (COAs) are...
    Webinar

    Xtalks | EU Clinical Trial Regulation: Latest Developments and Upcoming Opportunities

    The EU clinical trial landscape has changed significantly since Regulation (EU) No 536/2014 became applicable on January 31, 2022, and sponsors now need a clear view of how the framework is operating in practice and where it may evolve next. This webinar explores the current ...
    Checklist

    Veeva RIM TMS Integration Checklist

    If your regulatory team is still downloading documents from Veeva Vault, managing translation requests by email, or tracking submissions in spreadsheets, there's a better way. Reduce complexity, close compliance gaps, and shorten your submission cycle times with this ...