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

    Gilead
    Syneos Health
    Boehringer Ingelheim
    Vertex
    CVS Health
    Biogen
    Merck
    Labcorp
    Bayer
    Takeda logo
    P&G
    Moderna
    Roche logo
    Sanofi logo

    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.

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

    Blog

    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 initiatives and introduces new filing requirements that will impact how regulatory, compliance, and medical writing professionals prepare, submit, and manage product monograph (PM) content. If your team is ...

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

    OpTImize London

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

    LifeSci Talks COA Series | Making the Most of Smaller Population Samples: Qualitative Insights in Rare Disease

    In this episode of LifeSci Talks, Mark Wade, Global Practice Leader at TransPerfect Life Sciences, sits down with Dr. Kate Williams, Director of Patient-Centred Outcomes Research at Acaster Lloyd, to explore the nuances of gathering and applying qualitative data in rare disease ...
    White Paper

    AI in Clinical Outcome Assessment (COA): Challenges and Opportunities

    In an increasingly interconnected and globalized world, effective cross-cultural communication is essential, making the development of accurate, efficient translation systems a top priority. ...
    White Paper

    The Total Economic Impact of TransPerfect GlobalLink for Life Sciences

    TransPerfect commissioned Forrester Consulting to conduct a Total Economic Impact™ (TEI) study and examine the return on investment (ROI) enterprises may realize by deploying GlobalLink. The objective of the framework is to identify the cost, benefit, flexibility, and risk ...

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