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.

    The Ultimate Clinical Trial Translations Checklist

    Clinical product development is an elaborate endeavor executed through a complex web of processes that are in large part accomplished through various document and communication work streams. These work streams can represent a significant source of cost, risk, and time. When a study operates across cultures, countries, and continents, these pain points of cost, risk, and time are compounded by the addition of translation and localization requirements. Study teams ...

    The Ultimate Clinical Trial Translations Checklist

    CCMS: A Good Fit for Pharmaceutical and Clinical Research Organizations?

    Kaarin Gordon discusses the choices and challenges for efficient content reuse facing Pharmaceutical and Clinical Research Organizations. What they want is a set of tools and platforms for easy content reuse, automatic propagation of changes from a single source, and content ...

    Omnichannel Marketing for the Pharmaceutical Industry

    With rapid globalization and expanded marketing efforts, pharmaceutical organizations are discovering that pivoting from multichannel marketing to omnichannel marketing is key to revolutionizing patient engagement. Through tailored experiences across relevant channels, your teams ...

    LifeSci Talks COA Series | The Future of Capturing Patient Data in Clinical Trials: DCTs, Site Staff Burden, and Regulation Considerations with Paul O'Donohoe

    Mark Wade interviews Paul O'Donohoe, Senior Director of Product for eCOA and COA at Medidata. They delve into the challenges and opportunities of adopting decentralized clinical trials (DCTs) and explore topics such as mixed modalities for data capture, patient burden, site ...

    Walking the Tightrope: Navigating Patient Centricity and Burden in Modern Clinical Trials

    Over the past few decades, clinical trials have witnessed remarkable developments - but they are not without challenges. Dropout rates of up to 20% indicate that patient burden and engagement remain key areas of concern. In response to this, sponsors, healthcare providers,...

    Health Canada's XML Mandate: Pioneering the Future of Pharmaceutical Content

    In 2019, Health Canada initiated a significant process to transition all product monograph templates into a more advanced and structured XML format. This move by the regulatory authority has raised several questions for Canadian pharmaceutical organizations' regulatory and...

    Leveraging Technology and Bridging Gaps for Enhanced Clinical Data Management

    Introduction: In the field of clinical research, a robust data management process is essential for driving success. Efficiently handling vast amounts of data, ensuring accuracy and consistency, and extracting meaningful insights are vital, particularly in the case of global...

    Ready to mitigate the obstacles from global regulatory submissions?