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?

    Get in touch ›

    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.

    Accelerating Pharma Labeling with Intelligent, Compliant Content

    White Paper

    Juggling multilingual labels across varying regions and products? Managing the updates and complying with local health authorities' requirements can be a challenge for global pharmaceutical companies, who are facing increasing pressure to streamline labelling processes and digitize labels. This white paper details how a unified eLabeling solution can eliminate duplication, improve accuracy, and deliver measurable ROI. ...

    Accelerating Pharma Labeling with Intelligent, Compliant Content
    Blog

    Health Canada's Transition to XML: What Regulatory Teams Need to Know

    In a continued push toward modernization and transparency, Health Canada has entered the next phase of its digital transformation with a mandate requiring the use of advanced extensible markup language product monograph (XML PM) files. This change builds on earlier...
    Webinar

    LifeSci Talks COA Series | Balancing Innovation and Integrity: AI’s Place in Patient-Focused Research

    Artificial intelligence is redefining what’s possible across the clinical development lifecycle, but with rapid innovation comes the need for thoughtful oversight. In this episode of LifeSci Talks, Mark Wade, Global Practice Leader at TransPerfect Life Sciences, sits down with ...
    White Paper

    Web Localization Playbook for Life Sciences

    The life sciences industry relies on websites to connect with patients, sites, and global audiences. Whether you're launching a patient recruitment campaign or managing an international healthcare marketing initiative, localization ensures your message is not just understood ...
    Webinar

    Rewriting the Rules of Informed Consent Development with AI

    Regardless of the market a clinical trial is being conducted in, getting locally approved informed consent forms (ICFs) consume as much as 12% of a clinical trial budget before it even begins. Each ICF must be clear and delicately balance local regulations and patient ...
    Guide

    Multilingual IMP Labeling Quick Guide

    Meet global regulatory expectations the first time with these efficient, cost-effective, and compliant product labeling solutions and considerations. ...
    Event

    OpTImize London

    - | Park Plaza London Westminster Bridge 200 Westminster Bridge Road London, England, United Kingdom, SE17UT ...