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.

    C3 Summit 2024 - Princeton

    Event

    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 2024 - Princeton
    Webinar

    Lessons Learned from SCMS Deployments in Global Medical Device Documentation

    Transitioning to modular content using a Structured Content Management System (SCMS) has the potential to transform medical device documentation by streamlining authoring and automating content updates and publishing. For a truly successful implementation, however, early planning ...
    Webinar

    LifeSci Talks | Measuring What Matters: Modernizing Clinical Outcome Assessments with Patient-Centric Approaches

    In this episode of LifeSci Talks, TransPerfect’s Global Practice Leader Mark Wade sits down with Dr. Karl McEvoy, VP of eCOA and Patient Technology at YPrime, to discuss the importance of embracing technology in clinical research to reduce the patient burden. The two cover ...
    Blog

    7 Essential Steps to Reach Global Audiences with Website Localization Services for Life Sciences Organizations

    Website Localization for Life Sciences Organizations Means Greater Global ReachLife sciences organizations are under increasing pressure to connect with global audiences. With 65% of internet users preferring websites in their native language and 40% refusing to buy from...
    Guide

    Harnessing AI in Pharmacovigilance: Insights from World Drug Safety Amsterdam 2024

    Pharmacovigilance professionals face an escalating challenge: data overload. From AI-powered transcription and case triage to automated literature translation, insights from the World Drug Safety Congress 2024 showcased practical solutions for streamlining workflows and reducing ...
    Blog

    Harnessing AI in Pharmacovigilance: Insights from World Drug Safety Amsterdam 2024

    IntroductionIn the pharmacovigilance space, the overwhelming trend in the current landscape is data overload. Increasingly unmanageable volumes of information pose a core challenge for today’s pharmacovigilance professionals. While digital transformation and new technologies...
    Webinar

    LifeSci Talks | Effective Rater Training: A Critical but Overlooked Part of COA Administration

    In this episode of LifeSci Talks, TransPerfect Life Sciences’ Global Practice Leader Mark Wade sits down with Kelly Dumais PhD, Director of eCOA Science at Clario to discuss the significance rater training plays in standardizing the administration and scoring of clinical scales. ...

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