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.

    Patient Recruitment: Clinical Research's Costliest Bottleneck

    Patient recruitment is the costliest bottleneck in clinical research. Learn proven strategies to reduce study delays, optimize enrollment, and cut regrettable spend. ...

    Patient Recruitment: Clinical Research's Costliest Bottleneck
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    Operationalizing AI in Global Pharma Product Launch

    AI has moved from a sensitive topic to a standard expectation in pharmaceutical organizations. Leadership teams are asking for it. Departments are experimenting with it. Pilot programs are underway across the enterprise.Yet despite this momentum, most AI initiatives stall...
    Webinar

    Process AI in Medical Device: What Works and What’s Next

    The webinar will also explore the use of Process AI across life sciences operations. Instead of treating each process, such as post-market surveillance, complaint handling, systematic literature review and regulatory content authoring, like separate AI projects, this session will ...
    Blog

    Localizing Health Apps at Global Scale: UI/UX Considerations

    With 200 new mHealth (mobile health) apps launching daily, it’s safe to say that the digital health market is exploding. For health-tech startups and established organizations looking to scale across global markets, the differentiator in a competitive landscape isn’t always...
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    Back to the Basics: Foundations of COA Localization

    This blog is a follow-up from our webinar Foundations of Clinical Outcome Assessment Localization.Clinical outcome assessments (COAs) play an increasingly central role in capturing how patients feel, function, and experience their condition or treatment. Yet as studies...
    Webinar

    Integrating AI to Scale & Accelerate Workflows and Improve Pharma Product Launches

    Bringing a new medical product to market has always been a challenge, though advances in recent tools have promised a new age of streamlined processes and accelerated time to launch. However, most pharma commercial AI pilots never make it past proof of concept due to siloed ...
    Webinar

    Optimizing COA/eCOA Workflows with Technology for Better Quality & Timelines

    Efficient workflows are critical to keeping global COA/eCOA studies on schedule while ensuring the quality of localized content. This live webinar will explore how technology stacks and automation can streamline clinical localization from start to finish, through integrating ...