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.

    AI and MT "Ask and Expert" Office Hours - 4/10/2024

    TransPerfect's experts gather to answer questions from global pharma, biotech, and medical device leaders regarding AI and MT use cases, challenges, opportunities, best practices, and more. ...

    AI and MT "Ask and Expert" Office Hours - 4/10/2024

    Multilingual Labeling: Considerations for Efficient, Cost Effective and Compliance Labeling

    Accurate and compliant labeling of an investigational medicinal product (IMP) is an important and integral part of clinical trial operations. A misstep in labeling can lead to significant delays, affecting the entire study’s timeline and potentially incurring costs ranging from ...

    An Overview of Generative AI and Machine Translation for Life Sciences

    Global life sciences companies are realizing the potential artificial intelligence (AI) and machine learning (ML) has to drive efficiency in content and translation management. To capitalize on this, organizations need to identify the right solutions. Discover important ...

    6 Pathways to Take Your MT Strategy to the Next Level in 2024

    With 2024 well underway, innovators in the global life sciences and pharmaceutical industries continue to question how to maximize efficiencies and reduce complexities in clinical and regulatory content development and localization. As part of the broader technological roadmap, ...

    Ready to mitigate the obstacles from global regulatory submissions?