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

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

    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.

    Integrating eCOAs and Digital Health for Patient-Centric Trials

    Blog

    A New Era of Patient-First Design  Clinical research is undergoing a fundamental transformation as technology takes on a larger role in how trials are designed and executed. This shift is not simply about digitizing paper-based processes, but about creating ecosystems that allow patients to engage with research in ways that feel natural and supportive. At the center of this evolution is the principle of patient-first design, which ensures that participants are ...

    Integrating eCOAs and Digital Health for Patient-Centric Trials
    Success Stories

    Opening Doors Worldwide: Launching a Top 10 Pharma’s Careers Site in 15 Languages

    With an ambitious global rollout deadline and limited internal bandwidth, this top 10 pharma company needed a smarter way to scale localization. Learn how automation and streamlined workflows helped transform the candidate experience across 15 markets, without slowing down speed ...
    Success Stories

    From Local to Global: How a Top 10 Pharma Leader Delivered Trial Access in Nine Languages

    Discover how one of the world’s leading pharmaceutical companies made its clinical trial website accessible to global patients, but faced tight timelines, limited resources, and shifting systems. See how the team overcame these challenges to launch a multilingual site that set a ...
    Webinar

    Optimizing Technology and Automation for Digital Health Products

    Accurate and culturally appropriate translation of clinical outcome assessments (COAs), including patient-reported outcome measures, is essential to ensuring reliable data in multinational trials. Foundations of Clinical Outcome Assessment Localization will provide a practical ...
    Webinar

    Foundations of Clinical Outcome Assessment Localization

    Accurate and culturally appropriate translation of clinical outcome assessments (COAs), including patient-reported outcome measures, is essential to ensuring reliable data in multinational trials. Foundations of Clinical Outcome Assessment Localization will provide a practical ...
    Webinar

    Life Sciences Learning Trends - Office Hours Q&A

    Join the TransPerfect Learning team for an interactive virtual C3 Study Session, focused on the latest commercial learning trends transforming the life sciences industry. Whether you attended LTEN 2025 or are simply passionate about advancing learning & development in your ...
    Webinar

    AI in Pharmacovigilance: A Catalyst for Progress or a Tradeoff to Human Potential?

    In an environment as high stakes as pharmacovigilance, AI is not just about technology implementation; it's about balancing compliance, patient safety, and developmental breakthroughs. In this session, industry experts Dr. Siva Kumar Buddha of Amgen alongside TransPerfect& ...