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.

    C3 Summit 2024 - Princeton

    Event

    Conversations on Clinical Content, C3 Summit is part of a series of events hosted by TransPerfect Life Sciences featuring sessions with expert panels discussing present challenges, strategies, and innovations, as well as insights into future advancements, from R&D to commercialization. The event offers sponsors, CROs, and biotech professionals opportunities to share knowledge, gain industry insights, and network. Please fill out the form to access the session ...

    C3 Summit 2024 - Princeton
    Webinar

    Lessons Learned from SCMS Deployments in Global Medical Device Documentation

    Transitioning to modular content using a Structured Content Management System (SCMS) has the potential to transform medical device documentation by streamlining authoring and automating content updates and publishing. For a truly successful implementation, however, early planning ...
    Webinar

    LifeSci Talks | Measuring What Matters: Modernizing Clinical Outcome Assessments with Patient-Centric Approaches

    In this episode of LifeSci Talks, TransPerfect’s Global Practice Leader Mark Wade sits down with Dr. Karl McEvoy, VP of eCOA and Patient Technology at YPrime, to discuss the importance of embracing technology in clinical research to reduce the patient burden. The two cover ...
    Blog

    7 Essential Steps to Reach Global Audiences with Website Localization Services for Life Sciences Organizations

    Website Localization for Life Sciences Organizations Means Greater Global ReachLife sciences organizations are under increasing pressure to connect with global audiences. With 65% of internet users preferring websites in their native language and 40% refusing to buy from...
    Guide

    Harnessing AI in Pharmacovigilance: Insights from World Drug Safety Amsterdam 2024

    Pharmacovigilance professionals face an escalating challenge: data overload. From AI-powered transcription and case triage to automated literature translation, insights from the World Drug Safety Congress 2024 showcased practical solutions for streamlining workflows and reducing ...
    Blog

    Harnessing AI in Pharmacovigilance: Insights from World Drug Safety Amsterdam 2024

    IntroductionIn the pharmacovigilance space, the overwhelming trend in the current landscape is data overload. Increasingly unmanageable volumes of information pose a core challenge for today’s pharmacovigilance professionals. While digital transformation and new technologies...
    Webinar

    LifeSci Talks | Effective Rater Training: A Critical but Overlooked Part of COA Administration

    In this episode of LifeSci Talks, TransPerfect Life Sciences’ Global Practice Leader Mark Wade sits down with Kelly Dumais PhD, Director of eCOA Science at Clario to discuss the significance rater training plays in standardizing the administration and scoring of clinical scales. ...

    Ready to mitigate the obstacles from global regulatory submissions?

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