Empowering Regulatory Teams with Global Content Solutions

Regulatory professionals have to keep pace with the ever-evolving landscape of global regulations to ensure compliance, mitigate risk, and avoid costly delays.

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Why Regulatory Teams Love TransPerfect

Our 30+ years of knowledge and experience in Regulatory Affairs allows us to create and curate strategic risk-based solutions to improve compliance, simplify submissions, and avoid post-market pitfalls. Here are some of your options:


    Medical Writing

    Simplify content creation for a range of regulatory document types, including eCTD preparation and publishing.

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    Regulatory Consulting

    Create a roadmap to navigate complex regulatory requirements through TransPerfect’s network of regulatory expertise in 100+ countries, to ensure compliance to current and ever-changing regulations.

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    Translation

    We employ certified linguists, state-of-the-art…management technology to address the needs and challenges associated with the development process while following regulatory guidelines.

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    Workflow Management Technology

    Streamline the management of translations for submissions using an AI-powered platform to drive workflow automation, lock previously approved content, and facilitate online review and approval in any language.

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    Regulatory Documents and Submissions Powered by Trial Interactive

    Author regulatory documents, review, approve, and manage submissions in a single 21 CFR Part 11-compliant platform.

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    Your Partner in Navigating Global Regulations and Submissions

    Get strategic global regulatory support throughout the product development life cycle from pre-clinical through clinical trials to marketing authorization and commercialization.

    Trusted by Life Sciences Organizations Big and Small

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    News and Thought Leadership

    Industry insights from our experts. We have the experience and solutions you need to navigate life sciences complexity and bring breakthroughs from lab to launch.

    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 ...