A Faster Way to Complete Global Regulatory Submissions

Choose consulting and content solutions that help you clear regulatory hurdles and demonstrate product safety and effectiveness.

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Solutions That Expedite Regulatory Submissions

Content translation for regulatory submissions can shift deadlines, slow cycle times, and delay product releases. Find solutions for expediting submissions in a safe, timely, and cost-effective way.

    Product Information Translations

    Mitigate risk of human error in label production with labeling management technology that creates savings of up to 40% in translation and project management costs of global submissions (including centralized procedures in Europe, dossiers in Latin America or Asia, and Health Canada submissions).

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    Medical Writing

    Deliver first-class medical writing with analysis, creation, translation, and SME support for your regulatory documentation. Know your content is clear, concise, and follows global regulations.

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    Regulatory Translation Management

    Manage the translation of regulatory documents within one AI-powered ecosystem, integrated with Veeva and other RIMs, to ensure compliance and facilitate market access and approval.

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    eCTD Support

    Seamlessly integrate translated regulatory documents into electronic Common Technical Document (eCTD) format for efficient submission and review.

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    Navigate the Complexity of Global Regulatory Submissions

    TransPerfect helps regulatory departments reduce filing timelines and avoid critical errors and regulatory roadblocks. TransPerfect's word and phrase database generates savings by eliminating duplicate translations, which shortens overall timelines. With offices in over 100 cities and a worldwide network of experts specifically trained in mitigating risks associated with terminology and template non-compliance, there is no better partner to support your regulatory and labeling requirements than TransPerfect Life Sciences.

    Streamlined Regulatory Submissions by the Numbers

    40 %

    Savings in translation and project management costs

    140 +

    Offices in major cities

    125 k

    Global clinical studies supported

    30 +

    Years of experience

    Regulatory Translation Solution Saves $1.1M for Global Pharma Company

    regulatory writing

    TransPerfect Life Sciences centralizes and integrates regulatory affairs global translations with GlobalLink and Veeva RIM.

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    News and Thought Leadership

    Our industry experts have in-depth understanding of the challenges, requirements, and goals for life sciences organizations.

    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 ...

    Ready to mitigate the obstacles from global regulatory submissions?

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