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

    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.

    Fast, Compliant, Centralized Translation in Action: Lessons from AbbVie & Immunovant

    Due to high interest following our GlobalLink NEXT panel, we’re welcoming back Stacey Higgins, Associate Director, COA & Digital Implementation Team of AbbVie alongside Tihirah Harris, Sr Manager, Clinical Business Operations of Immunovant to share how and why they moved to a centralized, tech-enabled translation model—enabling faster trial timelines, cost control, and regulator-ready content. We'll also cover what’s ahead on their centralization roadmap, ...

    Fast, Compliant, Centralized Translation in Action: Lessons from AbbVie & Immunovant
    Blog

    How Patients Discover Clinical Trial Websites: The Role of Localization in Search and Trust

    Could localization be the key to improving patient recruitment in clinical trials?Recruiting participants for clinical trials is a critical step in bringing new therapies and treatments to market, but despite advances in digital outreach, the industry still faces major...
    Webinar

    LifeSci Talks COA Series | Modernizing eCOA: Emulators, Backups, and the Future of Reporting

    In this tech-forward episode of LifeSci Talks, Mark Wade, Global Practice Leader at TransPerfect Life Sciences, welcomes Indira Jain-Figueroa, Product Director at Evinova, for a deep dive into the ever-evolving landscape of eCOA development. Covering everything from cross ...
    Blog

    Rewriting the Rules of Informed Consent Development with AI

    How AI and Structured Content Management Are Transforming the ICF ProcessInformed consent forms (ICFs) are essential to clinical trials, serving as the primary vehicle for communicating study information to participants in a clear, ethical, and compliant manner. Given...
    White Paper

    Could Data Standardizations be the Silver Bullet for Faster Electronic Clinical Outcome Assessment (eCOA) Deployment?

    Choosing an electronic clinical outcome assessment (eCOA) provider is a complex process that involves a variety of different aspects including experience, scientific support and knowledge, integration capabilities, scalability, study-specific requirements, and so much more. ...
    White Paper

    Accelerating Pharma Labeling with Intelligent, Compliant Content

    Juggling multilingual labels across varying regions and products? Managing the updates and complying with local health authorities' requirements can be a challenge for global pharmaceutical companies, who are facing increasing pressure to streamline labelling processes and ...
    Webinar

    Engaging Patient Communities: A Pathway to Clinical Trial Success

    In this webinar, expert speakers from MTS Sickle Cell Foundation, Inc, Rare Disease Diversity Coalition, Black Women’s Health Imperative, and Clinical Research Associates, Inc. will focus on the critical role of patient communities in advancing clinical trials. They will ...

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