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Translating Medical Writing for Global Regulatory Success

At Sesen, we provide specialized translation and localization support for regulatory medical writing to help life sciences companies achieve global compliance. Our services bridge the gap between scientifically accurate authoring and precise multilingual communication, ensuring your documents meet the submission requirements of health authorities worldwide.

Whether translating Clinical Study Reports (CSRs), Clinical Evaluation Reports (CERs), or CTD modules, we deliver medically accurate and linguistically consistent content that aligns with EMA, FDA, PMDA, and other regulatory standards. Precision in terminology, clarity of expression, and alignment with country-specific expectations are central to every project we support.

With exclusive focus on life sciences and a global network of professional native translators with subject matter expertise, Sesen ensures your regulatory content is not only accurately translated but also submission-ready for international review.

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What Is Regulatory Medical Writing Translation?

Regulatory medical writing translation refers to the process of translating scientifically authored documents that are prepared for regulatory submission into one or more target languages. These documents include highly structured, technical content such as Clinical Study Reports (CSRs), Clinical Evaluation Reports (CERs), and other components of the Common Technical Document (CTD). The goal is to maintain scientific accuracy, regulatory clarity, and linguistic precision across markets.

This service differs from standard medical translation. While general medical translation focuses on adapting clinical or healthcare-related content, regulatory medical writing translation requires an understanding of both scientific writing conventions and the specific formatting, language, and compliance standards expected by health authorities such as the EMA, FDA, and PMDA. It involves more than linguistic conversion. It requires regulatory awareness, therapeutic area knowledge, and terminology control at the level of an experienced medical writer.

Translation is often required when global dossier harmonization is needed for multinational submissions, such as when parallel filings are made in the EU, United States, Japan, or other markets. It also plays a critical role in preparing region-specific versions of documents for local regulatory review and approval. By ensuring that every language version of a submission reflects the same scientific rigor and regulatory alignment, companies can reduce approval delays and support smoother market access.

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Documents We Translate and Support

Sesen provides specialized translation and linguistic validation for a wide range of regulatory medical writing documents. Each file type follows strict formatting, terminology, and compliance requirements tailored to global and regional health authority expectations. Our linguists work closely with regulatory experts to ensure accuracy, clarity, and consistency across all submission materials.

Comprehensive translations of ICH E3-compliant CSRs for NDA, BLA, and MAA submissions. Focus on maintaining data integrity, clarity of results, and traceability to source documents.

Translations aligned with EU MDR and MEDDEV 2.7/1 guidelines. Support includes consistent terminology across clinical evidence, device performance, and risk-benefit assessments.

Accurate and confidential translation of investigator-facing content. Includes study rationale, safety data, and pharmacological profiles tailored for global site distribution.

Standardized translations of patient case summaries across safety populations. Emphasis on consistency, medical accuracy, and alignment with pharmacovigilance standards.

Clear and compliant translations of RMPs per EMA or regional authority guidelines. Includes safety specification, pharmacovigilance plans, and risk minimization measures.

Accurate translation of periodic benefit-risk evaluations, ensuring alignment with ICH E2C(R2) and local pharmacovigilance regulations.

Translation of core labeling content including indications, dosage, contraindications, and adverse reactions, formatted per EMA QRD templates.

Scientific translations of toxicology, pharmacokinetics, and pharmacodynamics reports. Terminology aligned with CTD Module 4 requirements.

Multilingual support for overviews, summaries, and full study reports in Modules 2.5, 2.7, and 5. Delivered in submission-ready format with consistent scientific language.

Translation of regulatory documents including GSPR checklists, PMCF plans, and clinical evidence reports. Fully aligned with EU MDR and IVDR requirements.

Translations of non-technical summaries for patients and the public. Focus on language clarity, health literacy, and compliance with EU Clinical Trial Regulation.

Fast-turnaround translation of formal responses to EMA, FDA, PMDA, and other agencies. Includes support for comment matrices and clarification letters.

Integrated Multilingual Authoring and Translation Workflow

Sesen delivers a unified workflow that integrates regulatory medical writing and translation to support global submissions with precision and consistency. Our process is designed to maintain the scientific integrity of the original content while adapting it for multilingual compliance.

We begin by aligning all projects with client-approved terminology, therapeutic area-specific style guides, and standardized glossaries to ensure linguistic and regulatory consistency. Our teams collaborate closely with medical writers to preserve the intended meaning, tone, and data presentation across languages.

Translation memory tools and version control systems are used throughout the workflow to streamline updates, manage revisions, and ensure alignment across related documents. This is especially critical for large-scale submissions that involve iterative review cycles and parallel authoring in multiple regions.

Each project includes built-in quality assurance and feedback loops involving bilingual medical reviewers, in-country experts, and regulatory consultants. This layered review process ensures that translated content meets local regulatory expectations and maintains fidelity to the source document at every stage.

Sesen’s integrated approach reduces rework, shortens timelines, and helps clients meet regulatory milestones with confidence in every language.

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Regulatory Frameworks and Compliance

Sesen provides translation and localization services aligned with the regulatory requirements of major global health authorities, supporting clients through every stage of clinical and post-marketing submissions. Our work adheres to internationally recognized guidelines and quality standards to ensure your translated content is accurate, compliant, and submission-ready.

We support multilingual documentation for regulatory bodies including the EMA, FDA, PMDA, Health Canada, MHRA, TGA, and NMPA. Our teams are experienced in working within the structure of the Common Technical Document (CTD) and electronic CTD (eCTD), ensuring proper formatting and consistent content across Modules 1 through 5.

For medical devices and diagnostics, we specialize in translating documents required under the EU MDR and IVDR, such as Clinical Evaluation Reports (CERs), Post-Market Surveillance Plans, and Summary of Safety and Clinical Performance (SSCP) files.

All projects follow ISO 17100 and ISO 9001:2015 certified processes, with clearly defined quality control steps, traceability, and regulatory alignment. Whether preparing documents for initial submission or responding to health authority queries, Sesen ensures linguistic precision and compliance across languages and jurisdictions.

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Advanced Human Translation with Intelligent Technologies

Sesen combines expert human translation with the latest linguistic tools to deliver high-quality, scalable solutions for regulatory medical writing projects. Our approach enhances accuracy, consistency, and efficiency while preserving the scientific and regulatory integrity of your documents.

We support hybrid workflows that incorporate machine translation post-editing (MTPE) when appropriate, particularly for high-volume documentation that does not compromise safety or regulatory meaning. All MTPE outputs are reviewed by professional medical linguists with therapeutic area expertise to ensure compliance with agency expectations.

Our translation solutions are designed to integrate with your document management systems, including platforms like Veeva Vault, to streamline version control, approval cycles, and audit trails. This interoperability reduces friction in your internal workflows and supports seamless collaboration across functions.

Sesen also works closely with internal and external medical writing teams to align on terminology, document conventions, and submission timelines. This coordination ensures that every translated document meets both linguistic and regulatory requirements from the first draft through final delivery.

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Why Choose Sesen

Sesen is a trusted partner for life sciences companies seeking precise and compliant regulatory medical writing translation. Our services are built on deep domain expertise, linguistic excellence, and operational scalability to meet the demands of global submissions.

Exclusive Life Sciences Focus

We specialize solely in life sciences translation, with dedicated expertise across pharmaceuticals, biotechnology, medical devices, and CRO support. Every project benefits from our understanding of complex scientific content and evolving regulatory requirements.

Regulatory-Trained Native Linguists

Our linguists are native speakers with backgrounds in regulatory affairs, clinical research, and therapeutic specialties. This ensures that every translation reflects the tone, terminology, and structure required for successful agency review.

Dedicated Project Management and Quality Assurance

Each project is managed by experienced professionals who oversee timelines, reviewer coordination, and quality control. Our workflows include multiple layers of review to ensure linguistic accuracy and regulatory alignment.

Scalable and Agile Delivery
Whether supporting a single NDA or a multinational dossier rollout, Sesen scales quickly to meet client needs. We offer flexible turnaround options, continuous delivery models, and rapid response for time-sensitive submissions.

Our clients choose Sesen for our commitment to accuracy, compliance, and responsiveness at every stage of the regulatory translation lifecycle.

Proven Expertise in Global Regulatory Submissions

Sesen recently supported a leading global biopharmaceutical company with the multilingual preparation of Clinical Study Reports (CSRs) and Clinical Evaluation Reports (CERs) as part of a centralized submission strategy to both the EMA and PMDA. The project involved translating over 400,000 words of regulatory medical writing content into five target languages, with strict adherence to ICH E3 and EU MDR guidelines.

Our linguists collaborated closely with the client’s internal medical writing and regulatory teams to ensure scientific accuracy, consistent terminology, and on-time delivery. Using customized glossaries and translation memory tools, we achieved linguistic consistency across related CTD modules while reducing turnaround time by 30 percent.

This project reflects Sesen’s ability to manage complex, large-volume regulatory documentation with the precision and speed needed for global compliance.

Related case study available at:
Regulatory Submission Translation for Global Biopharma

Related Services

Sesen offers a full suite of translation and multilingual content solutions to support regulatory, clinical, and medical documentation across product lifecycles. Clients seeking regulatory medical writing translation often benefit from the following specialized services:

  • Clinical Study Report Translation Services

    Professional translation of ICH E3-compliant CSRs for regulatory submissions in multiple languages, with a focus on accuracy, consistency, and submission-readiness.

  • CTD and eCTD Translation Services

    Translation and formatting support for all CTD modules, including Modules 2 and 5, to meet EMA, FDA, and PMDA submission standards.

  • IFU Translation for Medical Devices

    Native-language translation of Instructions for Use and related documentation to meet EU MDR and global market entry requirements.

  • Lay Summary Translation

    Clear, patient-friendly translations of clinical trial results in accordance with EU Clinical Trial Regulation and health literacy guidelines.

  • Labeling Translation Services

    Multilingual translation of product labeling, packaging, and safety information for pharmaceuticals, biologics, and medical devices.

  • Medical Writing Services

    Authoring and content development support for regulatory, clinical, and safety documents, with language alignment for global filings.

Each service is delivered through ISO-certified processes and supported by Sesen’s specialized linguists and regulatory experts to ensure clarity, compliance, and global alignment.

Need Regulatory Translation Support for Your Next Submission?

Partner with Sesen for accurate, submission-ready translations of your regulatory medical writing. From CSRs and CERs to CTD modules and health authority responses, our expert linguists and regulatory specialists are here to support your global strategy.

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