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.

    Strategic Artificial Intelligence (AI) Implementation for Medical Device Companies

    Guide

    AI isn’t just a tool—it’s a transformation. See how leading medical device firms use scalable, customized AI programs to cut costs, improve efficiency, and meet regulatory demands. ...

    Strategic Artificial Intelligence (AI) Implementation for Medical Device Companies
    Client Story

    Smith & Nephew Saves $200k Annually While Meeting MDR & IVDR Stringent Vigilance Requirements

    Part of TransPerfect's GlobalLink suite of productivity applications, GlobalLink Now is a simple, but powerful way to access secure, customized AI. The system has an intuitive UI for sign on and engagement, making the application easy to use and adopt. ...
    Webinar

    AI in Clinical and Regulatory Content: Trends, Challenges, and Opportunities

    During this webinar, we will unveil the results of our industry survey on the role of Artificial Intelligence (AI) in clinical and regulatory content. This session will explore how AI is being evaluated and applied to search, analyze, and generate clinical and regulatory content, ...
    Guide

    Avoiding Risk in Multilingual eCOA: FDA, EMA, and ISPOR Standards

    Regulatory agencies worldwide, including the FDA, EMA, and other health authorities, require eCOA translations to be accurate, validated, and culturally adapted. ...
    Webinar

    Driving Commercial Success in Life Sciences with GenAI for Scalable Impact

    Life sciences organizations are turning to AI/ML to enhance operational efficiency, with GenAI taking center stage as a game-changer for commercial teams. Beyond process optimization, AI is accelerating the adoption of omnichannel strategies by enabling and improving precise, ...
    Webinar

    Personalized Pathways: Building an Omnichannel Ecosystem for Life Sciences

    In an increasingly globalized digital landscape, the demand for personalized content has never been greater. Listen as Joy Wendelken from Johnson & Johnson alongside Sara Green of WebMD Ignite in conversation with Dana Weber from TransPerfect Digital discuss how omnichannel ...
    Webinar

    LifeSci Talks COA Series | Data Without Interpretation is Meaningless: Unlocking Inherent Value Within the Numbers

    In this episode of LifeSci Talks, Mark Wade, Global Practice Leader at TransPerfect Life Sciences, sits down with Elizabeth (Nicki) Bush, Executive Director and Global Head of Endpoint Strategy and COA Measurement at OPEN Health Group to discuss the growing complexity of ...

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