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.

Learn More
global

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).

    Learn More

    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.

    Learn More

    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.

    Learn More

    eCTD Support

    Seamlessly integrate translated regulatory documents into electronic Common Technical Document (eCTD) format for efficient submission and review.

    Learn More

    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.

    CAPTCHA
    This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
    Webinar cover image
    CAPTCHA
    This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.

    News and Thought Leadership

    Our industry experts have in-depth understanding of the challenges, requirements, and goals for life sciences organizations.

    Reddit Stories: AI Failures in Clinical Trials

    Clinical operations experts react to real AI failure stories pulled directly from Reddit and work backward to identify what should have caught them. From hallucinated citations that passed an initial review to AI-drafted guidance sent to a site without proper oversight, each story raises the same question: What would your team have done? ...

    Reddit Stories: AI Failures in Clinical Trials
    Webinar

    The Human in the Vault: Building Review Workflows That Satisfy Regulators

    AI translation is already fast enough for most teams. The gap is on the review side: who signs off, what gets logged, and whether the process holds up when a regulator asks. This session walks through a real human review workflow within an AI-assisted translation process ...
    Blog

    eConsent: Why the Content Matters as Much as the Tech

    Insights from a conversation with Edwin Cohen, Principal Consultant / Owner at C&Flow Instrument Creation and Mark P Wade Global Practice Leader & COA SME, TransPerfect Life Sciences For all the attention paid to the systems, platforms, and integrations behind...
    Success Stories

    Pragmatic Use Cases for AI in Medical Information

    The rapid advancement of AI presents medical information teams with powerful new opportunities to transform their operations. From inquiry intake and intelligent triage to case management and standard response development, AI-driven solutions are already delivering measurable ...
    Webinar

    LifeSci Talks COA Series | The "Frankenstein Instrument" Problem: Why Some PRO Measures Don't Fit Today's Patients

    Are the COA Instruments we've relied on for decades still measuring what matters to patients today? In this episode, Mark Wade sits down with Kathrin Fischer PhD, Patient-Centered Outcome Strategy Lead at Boehringer Ingelheim and ISOQOL Director-at-Large Term: 2024 – 2027, ...
    Blog

    Has eCOA Lived up to Its Promise? A Retrospective View on the Evolution of Electronic Clinical Outcome Assessments

    The Evolution of eCOA: Progress, Challenges, and the Road AheadElectronic clinical outcome assessments (eCOAs) were expected to make paper obsolete by improving data quality, reducing missing data, and enabling decentralized clinical trials.More than two decades later, that...
    Success Stories

    How a Leading eCOA Provider Cut Timelines by 60% with GlobalLink Strings Integration

    Discover how a leading eCOA provider slashed project timelines by 30% and screenshot review cycles by more than 60% by integrating GlobalLink Strings into its platform. This case study breaks down the roadmap, the rollout, and the efficiency gains that followed. See how ...