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.

    C3 Summit 2025 - San Francisco

    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 commercialization. The event offers sponsors, CROs, and biotech professionals opportunities to share knowledge, gain industry insights, and network. Please fill out the form to access the session ...

    C3 Summit 2025 - San Francisco
    Guide

    Website Localization Fact Sheet

    Language barriers are a measurable enrollment risk, and one that compounds fast. With 25.7 million people in the US living with limited English proficiency and 41% of adults reporting they know nothing about clinical trials, the patient pool is larger than most teams realize and ...
    Guide

    Patient Recruitment Strategies for Clinical Trials

    Most trials miss enrollment targets because patients don’t understand, trust, or act on the information they receive. The gap between a recruitment strategy built around patient comprehension and one that isn't, touches everything from screening drop-off to diversity goals. ...
    Guide

    Clinical Trial Website Localization: Accelerating Enrollment and Reducing Compliance Risk

    Language barriers are a measurable enrollment risk, and one that compounds fast. The gap between a localized and non-localized clinical trial website is wider than most teams expect, touching everything from regulatory compliance to participant drop-off. This infographic breaks ...
    Blog

    Medical Device Localization: Navigating Compliance and Empowering Engagement

    As medtech digital health ecosystems expand, companies face growing pressure to deliver products and information tailored to each global market. Meeting that demand requires a strategic approach to medical device translation and localization spanning cultural adaptation,...
    Success Stories

    Scaling Clinical and Regulatory Content with GlobalLink's Intelligent Performance

    A Top 10 pharma needed to accelerate clinical and regulatory translations without increasing compliance risk or slowing submissions. This case study shows how they kept content inside Veeva Vault with an automated integration and a hybrid model (AI + validated translation memory ...
    Blog

    The Role of AI and Machine Learning in Clinical Outcome Assessment Translation

    Author: Mark Wade, Global Practice Leader & COA SME, TransPerfect Life SciencesThere is little doubt across the industry that artificial intelligence (AI) and machine learning (ML) have changed the game, particularly when it comes to clinical research. From using it to...