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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Digital legal

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

    Gilead
    Syneos Health
    Boehringer Ingelheim
    Vertex
    CVS Health
    Biogen
    Merck
    Labcorp
    Bayer
    Takeda logo
    P&G
    Moderna
    Roche logo
    Sanofi logo

    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.

    AI in Clinical Outcome Assessment (COA): Challenges and Opportunities

    White Paper

    In an increasingly interconnected and globalized world, effective cross-cultural communication is essential, making the development of accurate, efficient translation systems a top priority. ...

    AI in Clinical Outcome Assessment (COA): Challenges and Opportunities
    Event

    RAPS Conference Takeaways

    The Quick Conference Catch Up is a device industry reporting service from TransPerfect Medical Device. Based on live attendance at premier regulatory and strategy conferences, each Catch Up uses a conversational format to recap and highlight key conference takeaways. In these ...
    Webinar

    AI and MT for Medical Information Office Hours -4/30/2025

    Welcome to TransPerfect Life Sciences' AI and MT Ask an Expert Office Hours. In these sessions, we provide an opportunity for our community to submit their pressing questions for our experts to answer live, in the company of your industry peers. If you are looking for some ...
    Webinar

    AI and MT for PV and Safety Office Hours - 4/23/25

    Welcome to TransPerfect Life Sciences' AI and MT Ask an Expert Office Hours. In these sessions, we provide an opportunity for our community to submit their pressing questions for our experts to answer live, in the company of your industry peers. If you are looking for some ...
    Webinar

    Ask an Expert Office Hours: Website Localization for Patient Recruitment - 4/24/25

    This session focuses on Website Localization for Patient Recruitment. Tackle your toughest patient recruitment and engagement challenges with free, no-strings-attached advice from TransPerfect's web localization and AI experts—no cost, no sales pitch, just solutions! ...
    Checklist

    Digital Health Global Expansion Roadmap

    For digital health companies—whether startups or tech giants—successfully launching new digital health apps starts with user adoption. To ensure long-term sustainability, these apps must attract, engage, and retain a diverse user base, which means they need to be culturally and ...
    Client Story

    Smith & Nephew Saves $200k Annually While Meeting MDR & IVDR Stringent Vigilance Requirements

    Part of TransPerfect's GlobalLink suite of productivity applications, GlobalLink Now is a simple, but powerful way to access secure, customized AI. The system has an intuitive UI for sign on and engagement, making the application easy to use and adopt. ...

    Talk to Our Global Regulatory Experts.

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