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.

    Keeping Patients at the Heart of Clinical Trials

    Webinar

    Clinical trial patient recruitment continues to be challenging. Even with shifts to decentralize clinical trials and the addition of new vendors and technology, recruitment still is the primary cause of delays or discontinuation. What could we be missing? In this webinar, we’ll discuss the current state of clinical trials, historical challenges of recruitment, and new thinking to integrate human touch and improve retention. We will share frameworks and ...

    Keeping Patients at the Heart of Clinical Trials
    Webinar

    LifeSci Talks COA Series | AI-Powered Innovations in Clinical Trials: Optimizing Every Step

    Explore how artificial intelligence is rapidly changing the landscape of clinical trials, from discovering new therapies and complex calculations to protocol optimization. Discover how AI can generate study protocols, consent forms, and more, saving time and resources. Join us to ...
    Guide

    Translation and Cultural Adaptation of Clinical Outcome Assessments (COAs): Is Machine Translation a Viable Option?

    As technology continues to advance and the need to expedite drug development increases, the applications of Machine Translation (MT) and Artificial Intelligence (AI) in the translation process should be further explored. The capabilities of iterative learning and feedback can ...
    Blog

    The Role of Artificial Intelligence (AI) in Clinical Outcome Assessments (COAs)

    Written by Mark Wade, Global Practice Leader, COA SME. Abstract  Artificial Intelligence (AI) is the new frontier for content creation, reuse of language assets; saving time and effort in the curation of documentation. The widely adopted generative AI tools, such as ChatGPT...
    Client Story

    Takeda and Psyon Promote ADHD Awareness through Gamified Learning

    Takeda and Psyon games sought to improve ADHD awareness while improving quality of life for individuals navigating the diagnosis. Their goal was to roll out an accessible experience across multiple regions, languages, and cultures to help as many individuals as possible. Watch ...
    Blog

    Five Essential Roles Artificial Intelligence Plays in Medical Writing

    In the biotech and pharmaceutical industries, the importance of effective communication cannot be overstated. With a responsibility to accurately convey critical scientific findings, regulatory updates, and patient information1, the pressure is on medical writing teams to...
    Event

    C3 Summit 2023 - Princeton

    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 ...

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