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.

    Clinical Outcomes Assessments (COAs) in Clinical Trials: Copyright and Licensing

    Author: Erin Sweeney, COA Director, Linguistic Validation In clinical trials, it is usually necessary for sponsors to obtain permission to use copyrighted materials, such as clinical outcome assessments (COAs). The process to obtain these permissions is called licensing. While a seemingly complex process, it is important to understand why it is necessary, what it consists of, and what needs to be done to ensure that the sponsor is complying with all the necessary ...

    Clinical Outcomes Assessments (COAs) in Clinical Trials: Copyright and Licensing

    Localizing Platforms for Digital Health: The Importance of Post-Localization Context Review

    In a landscape defined by continuous technological advancement, many organizations in the life sciences industry strive to increase audience engagement through digital modalities, such as mobile and web applications or web portals. Building a robust technological...

    C3 Summit London 2024

    | THE BREWERY 52 Chiswell St London EC1Y 4SA United Kingdom ...

    Unlocking the Power of AI and Machine Learning in Life Sciences

    Life sciences companies are putting artificial intelligence (AI) and machine learning (ML) into practice, realizing its potential to revolutionize adverse event detection, diagnostics, and more. For AI and ML to be truly effective, you need to give context to your data, teaching ...

    PRO Scheduling Considerations: Assessing Patient & Caregiver Burden in Clinical Trials

    In this episode of TransPerfect LifeSci Talks, Mark Wade, Global Practice Leader at TransPerfect Life Sciences sits down with Andrew Lloyd, Director at Acaster-Lloyd Consulting, to spotlight the burden of clinical research for patients, and their caregiver/family dynamics. From ...

    Navigating the Bias Challenge: Medical Data for Ethical AI in Life Sciences

    From drug discovery to personalized medicine, AI systems are broadly transforming how we approach health and disease. The clinical development life cycle generates enormous volumes of data, and its potential is fully realized through the strategic application of AI tools,...

    Achieving Global Success in Clinical Trial Recruitment

    TransPerfect's GlobalLink Connect integration with Adobe Experience Cloud enabled one of the world’s largest pharmaceutical companies to help visitors in 17 countries and 13 languages identify clinical trials that might be right for them or their loved ones. ...

    Ready to mitigate the obstacles from global regulatory submissions?