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Join us June 15–19 at Booth #2013 to explore global clinical and regulatory language solutions.
Precision Translations for Global Health Authority Engagement
Accurate and compliant translation is essential when submitting documents to national and international health authorities. From investigational applications and marketing authorization dossiers to public health policies and multilingual labeling, Sesen supports end-to-end language needs with precision and regulatory rigor.
We specialize in translating high-stakes submission materials across a broad range of use cases, including:
- Product approval filings (e.g., INDs, NDAs, MAAs, BLAs)
- Clinical trial documentation
- Public health and epidemiological reports
- Regulatory correspondence and meeting briefings
- Patient information leaflets and safety labeling
Our services support companies and institutions in pharmaceuticals, medical devices, diagnostics, biotechnology, contract research, and public health, helping them navigate global compliance standards with linguistic accuracy and sector-specific expertise.
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Extensive Experience Translating for Global Health Authorities
Sesen delivers regulatory translation services trusted by leading life sciences organizations for submissions to health authorities worldwide. Our team has deep expertise supporting both ICH and non-ICH markets, including:
- ICH Regions:
– U.S. FDA
– European Medicines Agency (EMA)
– Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) - Non-ICH and Public Health Authorities:
– China’s NMPA
– World Health Organization (WHO)
– U.S. CDC and NIH
– Brazil’s ANVISA
– Korea’s MFDS
– India’s CDSCO
– Australia’s TGA
– Health Canada
We support a wide range of document types critical for regulatory filings, including:
- Clinical and public health applications such as INDs, CTAs, and IMPDs
- Marketing authorization dossiers including NDAs, BLAs, and MAAs
- Medical device and diagnostic submissions, from IFUs and GSPR checklists to UDI and multilingual labeling
- Policy and guidance documents issued by public health agencies
- Modular CTD and eCTD submissions, with expertise across Modules 1–5
Our linguists apply regulatory knowledge and scientific accuracy to deliver submission-ready translations tailored to the exact requirements of each authority and region.
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Certified Quality for Regulatory Submission Readiness
Sesen applies rigorous quality assurance protocols to meet the demanding standards of global health authority submissions. Our translation workflows are built on internationally recognized certifications and regulatory compliance frameworks to ensure accuracy, traceability, and data security.
Certified Translation Processes
Our operations are fully certified to ISO 17100 (translation services), ISO 9001:2015 (quality management), and ISO 13485:2016 (medical devices), ensuring repeatable, auditable quality across all regulatory deliverables.
Audit-Ready Documentation
We provide structured, version-controlled deliverables with complete revision histories—ready for submission or regulatory audit at any time.
Expert Linguist Network
All translations are performed by qualified, professional native linguists with subject-matter expertise in regulatory, clinical, and technical content.
21 CFR Part 11-Compliant Systems
We use secure, validated systems that support electronic records and signatures, with full traceability for submissions to the FDA and other digital-authority frameworks.
Change Management and Traceability
Every translation is managed with robust version control, enabling transparent collaboration and clear documentation of updates, comments, and reviewer changes.
With Sesen, clients can submit multilingual content to health authorities with full confidence in regulatory compliance and linguistic integrity.
Global Health Authority Submission Support
Sesen provides specialized translation services tailored to the requirements of global health authorities, enabling faster, compliant submissions across regions and regulatory frameworks. Our team supports life sciences companies in navigating country-specific formats, terminology expectations, and multilingual documentation standards—ensuring every submission is accurate, audit-ready, and aligned with local authority guidelines.
FDA (U.S.)
Sesen provides expert translation services for U.S. Food and Drug Administration (FDA) submissions, including Investigational New Drug (IND) applications, New Drug Applications (NDA), Biologics License Applications (BLA), and Structured Product Labeling (SPL) files. Our translations are formatted for eCTD compatibility and meet 21 CFR Part 11 requirements. We ensure precise use of FDA terminology and structure to support efficient regulatory review.
EMA (Europe)
We support full European Medicines Agency (EMA) submissions including Marketing Authorization Applications (MAA), multilingual translations of Summary of Product Characteristics (SmPC), Patient Information Leaflets (PIL), and labeling content for Decentralized and Mutual Recognition Procedures (DCP/MRP). Our linguists ensure compliance with QRD templates and EMA terminology standards across all EU languages.
PMDA (Japan)
Our Japanese medical translation specialists are experienced in adapting regulatory content for the Pharmaceuticals and Medical Devices Agency (PMDA). We translate Common Technical Documents (CTDs), clinical trial data, and pharmaceutical labeling with attention to Japanese regulatory phrasing, medical conventions, and bilingual formatting. We also support Japanese medical writing and bilingual submission summaries.
NMPA (China)
Sesen provides clinical, technical, and administrative translations for the National Medical Products Administration (NMPA) in China. We translate full drug and device registration dossiers, including pharmacological data, IFUs, and GMP documentation. Our linguists are fluent in Chinese regulatory language and ensure alignment with evolving NMPA submission requirements.
WHO, CDC, NIH
We offer multilingual translation support for submissions and documentation to global public health organizations such as the World Health Organization (WHO), the U.S. Centers for Disease Control and Prevention (CDC), and the National Institutes of Health (NIH). Typical materials include public health guidance, research funding applications, multilingual surveys, and health education content—translated with scientific accuracy and policy alignment.
ANVISA, MFDS, CDSCO, TGA, Health Canada
Sesen delivers comprehensive regulatory translation services for a wide range of regional authorities, including Brazil’s ANVISA, Korea’s MFDS, India’s CDSCO, Australia’s TGA, and Health Canada. We translate product dossiers, labeling content, quality and safety documentation, and Module 1 country-specific annexes. All content is localized to meet local terminology, formatting, and compliance expectations.
Advanced Workflow Support for Human-Centric Regulatory Translation
Sesen combines intelligent automation with human linguistic expertise to deliver high-quality, submission-ready translations at scale. Our technology-enhanced workflows are purpose-built for regulatory environments, ensuring consistency, efficiency, and compliance across global health authority filings.
Translation Memory and Terminology Management
We leverage advanced translation memory (TM) tools and client-specific termbases to maintain linguistic consistency across documents, reduce turnaround times, and lower costs—especially for large or rolling submissions.
AI-Assisted Quality Assurance with Human Post-Editing
Our QA workflows include automated linguistic checks, formatting validation, and regulatory terminology alignment, followed by full human review by qualified medical and regulatory linguists to meet submission-grade standards.
Integration with Submission and Content Management Systems
Sesen supports seamless integration with leading document and submission platforms such as Veeva Vault, MasterControl, and Lorenz DocuBridge, enabling streamlined handoffs, version control, and regulatory formatting compliance.
Scalable Infrastructure for Global Submissions
Our cloud-based translation environment is built for multilingual project orchestration, supporting simultaneous submissions to multiple authorities, real-time collaboration, and rapid updates in response to agency feedback.
Why Leading Life Sciences Organizations Choose Sesen
Sesen is a trusted language partner exclusively focused on life sciences, delivering accurate, compliant translations for regulatory submissions to health authorities worldwide. Our specialized approach is built to meet the complex demands of both public health institutions and private sector sponsors.
Life Sciences-Exclusive Expertise
We work solely within the life sciences sector, bringing deep regulatory knowledge to every translation project—from pharmaceuticals and biologics to medical devices and public health programs.
Specialized Linguists and Regulatory Experts
Our global network of professional native linguists includes subject-matter experts in clinical research, regulatory affairs, and medical writing, ensuring accurate and submission-ready translations across document types.
150+ Languages Supported
Sesen delivers multilingual submission support in over 150 languages, with full alignment to local authority terminology, formatting standards, and regional regulatory expectations.
Fast, Secure, and Scalable Workflows
Our ISO-certified processes, secure infrastructure, and scalable translation platform enable rapid turnaround and consistent quality, even for large or multi-country submissions.
Dedicated Account and Project Management
Every project is managed by a dedicated team that understands global submission cycles, eCTD requirements, and the importance of meeting critical filing deadlines with precision and clarity.
Case Studies & Success Stories
Sesen has supported high-impact regulatory and public health initiatives across the globe. Our experience delivering accurate, compliant translations under tight timelines has helped clients achieve successful outcomes with national and international health authorities.
Multilingual Support for a WHO-Aligned Vaccine Initiative
Provided end-to-end translation of clinical trial documentation, informed consent forms, and regulatory correspondence into 25 languages to support a global vaccine program aligned with WHO standards. Ensured consistent terminology and rapid turnaround across regions.
Accelerated EMA and PMDA Submissions for a Multinational Pharma
Delivered parallel translations of CTD Modules 1–5, labeling, and product information leaflets for simultaneous filings in the EU and Japan. Enabled the client to meet EMA and PMDA timelines through region-specific linguistic expertise and scalable workflows.
Public Health Labeling for Government Distribution in European Languages
Collaborated with a national health agency to translate patient safety labeling, dosage guides, and public information materials into different European languages. Managed in-country review and formatting to meet accessibility and compliance standards for widespread public distribution.
Frequently Asked Questions
What types of documents are required for health authority submissions?
We translate a wide range of regulatory and public health documents for submission to agencies such as the FDA, EMA, PMDA, NMPA, and WHO. Common file types include clinical trial applications (IND, CTA), marketing authorization dossiers (NDA, BLA, MAA), Common Technical Document (CTD/eCTD) Modules, Investigator’s Brochures, Product Information Leaflets, Structured Product Labeling (SPL), and health policy guidance. We also support multilingual labeling and packaging content.
How do you ensure translation accuracy for high-stakes content?
Sesen follows ISO 17100-certified translation processes, pairing each project with linguists who have domain expertise in regulatory, clinical, or public health sectors. Every document undergoes bilingual review, terminology validation, and QA using automated and human checks. We also use approved client glossaries and style guides to maintain consistency across submissions.
Can you handle urgent submissions or rolling updates?
Yes. We support expedited timelines for urgent regulatory filings, safety updates, and agency response letters. Our scalable workflows allow us to assign multiple linguists to priority projects without compromising quality. For ongoing submissions, we manage rolling updates with version control and change tracking to ensure alignment with regulatory revisions.
Do you provide in-country review coordination for regulatory labeling?
Absolutely. We facilitate in-country review (ICR) for multilingual regulatory labeling, patient leaflets, and packaging content. Our platform supports tracked changes and comment-based collaboration with local affiliates or country managers, ensuring compliance with national authority terminology and formatting requirements.
What systems or tools do you integrate with?
Sesen integrates with leading content and submission management systems, including Veeva Vault, MasterControl, and Lorenz DocuBridge, enabling direct handoffs and structured data exchange. We also support secure API integrations, cloud file sharing, and project dashboards for centralized submission management.
Ready to Translate Your Health Authority Submission?
Ensure your global submissions are accurate, compliant, and delivered on time with Sesen’s expert regulatory translation services.
Whether you’re preparing an IND, MAA, IFU, or multilingual labeling, our team is ready to support your next milestone.