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

    Ready to mitigate the obstacles from global regulatory submissions?

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    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.

    Potential Impact of the EU Biotech Act Proposal on Clinical Trial Activities

    Blog

    The European Commission’s proposed Biotech Act introduces changes that could reshape how clinical trials are approved and managed across the EU. While the broader package spans multiple areas of the health ecosystem, proposed updates to the EU Clinical Trial Regulation (EU CTR) stand out for their potential to address long-standing operational challenges including lengthy timelines, limited flexibility in submissions, and fragmented processes across member states. ...

    Potential Impact of the EU Biotech Act Proposal on Clinical Trial Activities
    Checklist

    A Checklist for eCOA Solution Deployment: Best Practices and Considerations

    Selecting and deploying a new eCOA solution involves many important factors - from determining the capabilities of the Language Service Provider (LSP) to identifying the technology used for each COA migration - and it’s impossible not to worry about missing a key detail in the ...
    Success Stories

    Fortune 500 Pharma Company Meets Critical Deadlines with TransPerfect Life Sciences’ COA Solutions

    This spotlight reviews the challenges faced by a Fortune 500 pharmaceutical company in implementing Clinical Outcome Assessments (COAs) to measure the impact of their products on patients. It discusses the need for accurate and culturally appropriate translations of COAs for ...
    White Paper

    Successful English Build & Language Migration

    Over the past decade, the global clinical trial landscape has changed drastically. A surge in technological innovation, including wearable devices, patient portals, and apps, has modernized how clinical data is collected and managed. With pen and paper becoming obsolete in the ...
    Blog

    Why 75% of Medical Device Manufacturers Are Disappointed with Their AI Results

    The Gap "The results we're seeing from AI are only as good as the data and structure we put behind it. Most manufacturers haven't done that work yet." — Marc Miller, Division President, TransPerfect Medical DeviceArtificial intelligence has arrived in medical device...
    Blog

    Metadata In, Metadata Out: Reducing RIM Submission Rework with In-System Translation

    Pharmaceutical companies spend billions and take years to bring therapies to market. Then many risk it all on a translation process managed with spreadsheets, email chains, and blind faith. Every label update, every safety amendment, every regulatory change notice must be...
    Blog

    AI Content Creation and Maintenance in Medical Information: Ending the Content Whack-a-Mole

    For many medical information (MI) teams, content maintenance can often feel like a game of whack-a-mole.Update one answer, three more pop up. Fix a regional version, and another channel drifts out of sync. Add a new piece of literature, and suddenly every approved response...