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.

    Trial Interactive Customer Summit, OpTImize

    Event

    Sheraton Times Square 811 7th Avenue New York, NY 10019 ...

    Trial Interactive Customer Summit, OpTImize
    Event

    AI & MT "Ask an Expert" Office Hours": PV and Safety

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    Event

    AI and MT "Ask an Expert" Office Hours": Clinical and Regulatory Documents and Content

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    Event

    AI & MT "Ask an Expert" Office Hours: Real World Data

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    Event

    Engaging Patient Communities: A Pathway to Clinical Trial Success

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    Guide

    Multilingual Labeling: Considerations for Efficient, Cost Effective and Compliance Labeling

    Accurate and compliant labeling of an investigational medicinal product (IMP) is an important and integral part of clinical trial operations. A misstep in labeling can lead to significant delays, affecting the entire study’s timeline and potentially incurring costs ranging from ...
    White Paper

    An Overview of Generative AI and Machine Translation for Life Sciences

    Global life sciences companies are realizing the potential artificial intelligence (AI) and machine learning (ML) has to drive efficiency in content and translation management. To capitalize on this, organizations need to identify the right solutions. Discover important ...

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