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Trusted Regulatory Translation Services for Life Sciences

Sesen provides specialized regulatory translation services that enable pharmaceutical, biotech, and medical device companies to meet global compliance requirements with confidence. We support the full range of regulatory documentation, including eCTD modules, quality manuals, audit responses, and safety data sheets. Our linguists are trained in EMA, FDA, MDR, and IVDR standards to ensure every translation meets current regulatory expectations. Translations are delivered in over 150 languages within an ISO 17100 and ISO 13485 certified framework to ensure accuracy, consistency, and submission readiness. From new product approvals to ongoing quality system documentation, Sesen combines technical precision with deep domain expertise to streamline multilingual regulatory workflows.

What We Translate

Sesen provides regulatory translation services across a wide range of document types critical to global compliance. Our team of subject-matter linguists ensures that every translation is accurate, regulator-ready, and aligned with current EMA, FDA, MDR, IVDR, and ICH guidelines. The following categories represent our core capabilities:

We support end-to-end translation of submission documents for market authorization across major regulatory regions.

  • CTD and eCTD Modules (Modules 1 to 5)
  • Product labeling, summaries of product characteristics (SPCs), and package inserts
  • Marketing authorization applications and technical dossiers for FDA, EMA, PMDA, and other authorities
    → [Explore: Regulatory Submission Translation Services]

Sesen translates quality system documentation to help maintain GxP compliance and meet ISO and regulatory expectations.

  • Standard Operating Procedures (SOPs)
  • Work Instructions (WIs) and training manuals
  • Quality manuals and process validation reports
  • Corrective and Preventive Action (CAPA) documentation

Our team ensures timely, accurate translations of correspondence with health authorities to support inspections and responses.

  • Responses to FDA 483 observations, EMA queries, and similar notices
  • Inspection reports, audit findings, and corrective action responses
  • Regulatory risk assessments and justifications

We translate pharmacovigilance documentation to support patient safety and meet pharmacovigilance reporting obligations.

  • Safety Data Sheets (SDS) and exposure reports
  • Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs)
  • Risk Management Plans (RMPs) and signal detection reports

Sesen provides high-accuracy translations of contractual and certification documentation required for global compliance.

  • Quality and technical agreements between sponsors, manufacturers, and CROs
  • Import and export licenses and regulatory registrations
  • Certificates of analysis, CE marking files, and declarations of conformity

Why Regulatory Translations Matter

High-quality regulatory translations are essential for life sciences companies seeking timely approvals, global product launches, and sustained market access. Inaccurate or inconsistent translations of submissions, SOPs, labeling content, or audit responses can result in regulatory rejections, inspection findings, compliance gaps, or product recalls. Regulatory bodies such as the FDA, EMA, PMDA, and ANVISA expect complete alignment between the source and target language versions of all submitted materials.

Sesen provides professional regulatory translation services that meet the evolving standards of MDR, IVDR, GxP, and ICH. Our linguists are trained in region-specific regulatory terminology and document structures to ensure clarity, completeness, and technical accuracy. With increasing scrutiny from authorities and shortened regulatory review timelines, having precise, submission-ready translations reduces risks and accelerates approvals across diverse global markets.

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Our Regulatory Translation Process

Sesen follows a structured, quality-driven translation workflow tailored to the stringent requirements of global regulatory environments. Each step is designed to ensure linguistic precision, technical accuracy, and compliance across jurisdictions.

Every project is assigned to professional native linguists with specialized backgrounds in regulatory affairs, pharmacovigilance, clinical research, or medical devices. Our translators understand the terminology, formatting, and document expectations of authorities such as the FDA, EMA, PMDA, and ANVISA.

We develop client-specific glossaries and style guides to maintain consistency across product lines, therapeutic areas, and global markets. Terminology is aligned with internal references and regulatory standards to support harmonized submissions.

Sesen performs rigorous in-context QA checks that go beyond basic proofreading. This includes label formatting validation, multilingual layout reviews, and verification of terminology within structured content such as SPCs and IFUs.

All translation projects are managed within our secure Translation Management System (TMS), hosted on AWS. Our platform is ISO 17100 and ISO 13485 certified and designed to protect sensitive regulatory data through encryption, access control, and audit trails.

Each project undergoes a multi-step quality assurance process, including bilingual review, client feedback integration, and a final check by a dedicated project manager to confirm accuracy, formatting, and completeness. This step ensures that translated documents meet all regulatory expectations and are ready for direct inclusion in submission packages or internal quality systems.

Sesen’s translation process is designed to reduce regulatory risk, accelerate approval timelines, and deliver consistent, high-quality results across every document type. By combining domain-specific linguistic expertise with rigorous QA and secure workflows, we help life sciences organizations maintain compliance across global markets.

Global Regulatory Expertise

Sesen provides regulatory translation services aligned with the requirements of major health authorities and regulatory bodies worldwide. Our team is well-versed in country-specific submission protocols, documentation formats, and linguistic conventions to support accurate, compliant translations for global regulatory filings.

We support regionally tailored translations for:

Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA), Drug Enforcement Administration (DEA)
Expertise in NDA, IND, BLA, and 510(k) submissions, as well as labeling, adverse event reporting, and controlled substance documentation.

European Medicines Agency (EMA), Notified Bodies under MDR and IVDR
Support for CE marking documentation, eCTD modules, IFUs, and multilingual labeling in accordance with EU regulations.

Pharmaceuticals and Medical Devices Agency (PMDA)
Translation of Japanese regulatory submissions, GCP documentation, and quality data for device and drug approvals.

National Medical Products Administration (NMPA)
Bilingual submission support for clinical trial applications, product registrations, and pharmacovigilance documentation.

Agência Nacional de Vigilância Sanitária (ANVISA)
Translation of dossiers, manufacturing records, and safety documents to meet Brazilian regulatory standards.

Health Canada
Support for Medical Device License (MDL) applications, DIN submissions, and bilingual packaging and labeling requirements.

International Council for Harmonisation (ICH), ISO standards, and World Health Organization (WHO) documentation
Sesen aligns with global frameworks to streamline submissions across regions and ensure regulatory consistency.

Our regulatory language support spans more than 150 languages and is backed by ISO 17100 and ISO 13485 certifications, giving global life sciences companies confidence in every submission.

AI-Supported Human Translation Workflows

Sesen combines the precision of professional human translators with the efficiency of advanced language technology to deliver accurate, compliant regulatory translations at scale. Our approach ensures consistency across document sets, reduces turnaround times, and supports multilingual alignment across regions and product lines. All final deliverables are reviewed by qualified linguists with domain-specific expertise to meet the highest regulatory standards.

We leverage client-specific translation memories and approved termbases to ensure consistent use of regulatory terminology across submissions, labeling, and quality documents.

When appropriate, we apply secure machine translation in early stages to accelerate workflows. Content is processed through encrypted, enterprise-grade MT engines hosted in a secure environment.

All machine-assisted translations undergo thorough human post-editing and multi-step QA to ensure accuracy, readability, and compliance with EMA, FDA, MDR, and other regulatory requirements.

Our AI-supported workflow enhances productivity without compromising the quality and regulatory integrity required in life sciences communications.

Case Studies

Sesen has supported leading life sciences companies with high-stakes regulatory translation projects across therapeutic areas, product types, and global markets. The following case studies highlight our experience in delivering accurate, submission-ready translations that meet stringent international requirements.

View Case Study: Labeling Translation & QA for In-Vitro Diagnostics

A global medical device company partnered with Sesen to translate and validate labeling content for an in-vitro diagnostic product in 15 languages. The project involved regulatory formatting, terminology harmonization, and in-context QA for parallel submissions across EU and APAC markets.

View Case Study: IFU Localization Case Study

Sesen provided end-to-end translation and localization of Instructions for Use (IFUs) for a Class III medical device under the EU MDR framework. The project included multilingual DTP, label validation, and compliance checks for submission to multiple notified bodies.

View Case Study: Multilingual Vaccine Submission Case Study

A leading CRO relied on Sesen to manage regulatory translations and linguistic validation for a global vaccine submission involving 25 languages. The project supported WHO prequalification and national regulatory approvals across Latin America, Africa, and Southeast Asia.

These case studies demonstrate Sesen’s ability to manage complex, time-sensitive regulatory translation projects with precision, scalability, and compliance across global health authorities.

FAQs: Regulatory Translation Services

Regulatory translation refers to the specialized process of translating documents used for product approvals, compliance reporting, safety documentation, and quality oversight within the pharmaceutical, biotechnology, and medical device sectors. These translations must meet the linguistic, structural, and formatting standards of regional health authorities such as the FDA, EMA, PMDA, and others.

Yes. In addition to regulatory submissions, Sesen translates a wide range of compliance-related materials including Standard Operating Procedures (SOPs), Corrective and Preventive Action (CAPA) documentation, Safety Data Sheets (SDSs), risk assessments, audit reports, and inspection responses.

Our translators and reviewers are trained in current global regulatory frameworks including EU MDR and IVDR, FDA 21 CFR requirements, and ICH guidelines. Each translation undergoes multi-step quality validation that includes formatting checks, terminology verification, and completeness reviews to ensure alignment with authority expectations.

Yes. We maintain a scalable team of regulatory linguists and project managers who can support urgent updates, labeling changes, and health authority follow-ups under tight timelines. Expedited service options are available for time-sensitive requests.

Yes. Sesen provides certified translations that include signed statements of accuracy. We also offer back translation, reconciliation, and notarization services when required for regulatory or legal purposes.

Need Accurate, Compliant Regulatory Translations?

Partner with Sesen for certified, regulator-approved translations that support product approvals, safety reporting, and quality compliance across all major markets. Our expert linguists deliver submission-ready content in over 150 languages with precision and speed.

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