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 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.

    The C3 Summit: Boston Recap

    Blog

    The second event in our series of C3 Summits took place in Boston on May 16, 2023. We invited industry experts and leaders to discuss challenges, opportunities, and strategies in clinical trial diversity, centricity, and outcome assessments through the lens of real-world experience. In this recap of the Boston session, we will review key points from each session.  Session 1: COA/eCOA Innovations – Licensing Hiccups, Linguistic Validation, ePRO Migration, and Best ...

    The C3 Summit: Boston Recap
    Blog

    How Medical Writing Can Drive Patient Engagement

    Medical writing is a critical component of the broader patient engagement landscape, establishing the foundations of communication between pharmaceutical companies and patients. The quality of medical communication can be transformational in how a patient engages with and...
    Webinar

    A Conversation with Dr. Elin Haf Davies of Aparito

    The rare disease space presents numerous challenges for clinical research and patient data capture. These challenges are only heightened for younger patient populations, where outcome measures and dosages need to be considered appropriately. Join Dr. Elin Haf Davies, Founder & ...
    Webinar

    Navigating the EU Clinical Trial Regulation Complexities - Current Challenges and Opportunities

    As the most significant change in the European Union clinical trial legislative ecosystem in 20 years, the European Union Clinical Trial Regulation 536/2014 (EU CTR) went live on January 31, 2022. The first-year transition period has now ended, and from January 31, 2023, EU ...
    Webinar

    How to Maximise Value and Avoid Failure During Life Sciences Dealmaking

    Please complete the form below to access the on-demand recording of our webinar. A fantastic expert panel of life sciences dealmaking veterans from AstraZeneca and Merck, with 100 years' collective experience, share their insights on key dealmaking strategies, best practices ...
    Blog

    Centralizing Global Content Solutions for Medical Affairs

    With a rapidly evolving landscape and the introduction of new technologies and emerging therapeutics, medical affairs professionals are tasked with remaining in lockstep with the latest industry developments. From a content perspective, this means not only maintaining clear...
    Webinar

    Automation for MDR & IVDR: A Three-Part Seminar - Part 3: EnCompass Step by Step: A Detailed View of the Content Automation Solution to Meet MDR & IVDR Requirements

    Part 3: EnCompass Step by Step: A Detailed View of the Content Automation Solution to Meet MDR & IVDR Requirements ...

    Talk to Our Global Regulatory Experts.

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