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.

    From Reactive to Strategic: How AI Is Transforming Medical Information Contact Centers

    Blog

    Introduction For decades, Medical Information (MI) has been an essential function within pharma, but largely a reactive one. This is especially true in medical information contact centers, which serve as the first line of support for HCPs and patients. When someone has a question about a product, they reach out, receive an answer, and the interaction is considered complete. But was it ever this simple? And what does that model look like in a digital environment where ...

    From Reactive to Strategic: How AI Is Transforming Medical Information Contact Centers
    Blog

    Five Domains the FDA Wants You to Measure in PROs for Cancer—and Why Translation Affects All of Them

    In a recent "LifeSci Talks" episode, TransPerfect Global Practice Leader Mark Wade and Signant Health VP and eCOA Scientist Bill Byrom PhD discussed how new FDA guidance is reshaping how sponsors approach patient-reported outcomes (PROs) in cancer clinical trials. PROs...
    Webinar

    AI in Medical Information: Challenges, Opportunities, and the Path to Compliant Content at Scale

    Medical information teams are being asked to do more with less; faster turnaround, broader content demands, and zero tolerance for inaccuracy. AI offers a way forward, but adoption comes with real challenges: how do you validate accuracy, integrate literature review, and build ...
    Webinar

    Xtalks | Improve Recruitment Outcomes Through More Diverse Clinical Trials

    Since the advent of artificial intelligence (AI), medical device manufacturers have been early adopters for product enhancements. Now, manufacturers are evaluating their regulated content and other production processes for suitable applications of AI and automation technology. ...
    Blog

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

    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...
    Blog

    5 Common eCOA Migration Issues

    With so many clinical trials now using COAs on electronic platforms, the practice of “migration” (transferring and adapting COAs for electronic use) has become more common than ever. Without careful implementation, one minor deviation can compound across many languages,...
    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 ...