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Why Accurate Legislative Translation Matters in Life Sciences
In the highly regulated world of life sciences, the accurate translation of medical and pharmaceutical legislation is critical to global market access, compliance, and public safety. Whether submitting a new drug application to the EMA, aligning with FDA regulations, or navigating country-specific healthcare laws, companies must ensure that legislative content is translated with legal precision and scientific accuracy.
Errors or ambiguities in translation can lead to regulatory delays, legal exposure, or costly noncompliance. That’s why Sesen specializes exclusively in life sciences translation, offering deep domain knowledge across pharmaceuticals, biotechnology, medical devices, and public health. Our expert linguists and legal SMEs deliver regulation-ready translations that align with jurisdictional requirements and support successful audits and submissions.
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What We Translate
Sesen provides expert translation of complex legislative and regulatory documents critical to compliance in the life sciences sector. Our linguists and legal experts work together to ensure that every translation reflects the precise intent of the original text while aligning with country-specific terminology and regulatory frameworks.
National and International Health Laws
Translation of statutes, acts, and ordinances governing national healthcare policies and international health regulations (e.g., WHO, EU).
Pharmaceutical Legislation and Regulatory Acts
Legal texts covering drug approval, marketing authorization, pricing, and reimbursement policies across jurisdictions.
Drug Safety and Pharmacovigilance Laws
Translations of laws governing adverse event reporting, risk management plans, and regulatory surveillance requirements.
Healthcare System Regulations
Policies outlining standards for care delivery, provider obligations, hospital accreditation, and patient rights.
Medical Device Directives and Regulations (e.g., EU MDR/IVDR)
Translation of medical device legislation including technical documentation, conformity assessment procedures, and post-market surveillance requirements.
Public Health Policy Documents
Official guidance and legislation related to infectious disease control, vaccination mandates, health campaigns, and emergency response laws.
EMA, FDA, PMDA, NMPA Legislative Requirements
Regulatory frameworks and submission requirements from leading health authorities in Europe, the U.S., Japan, and China.
Patent Laws and Exclusivity Clauses
Legal language relating to pharmaceutical intellectual property, including market exclusivity, supplementary protection certificates (SPCs), and patent linkage systems.
Labeling and Advertising Laws for Pharmaceuticals
Translation of laws and enforcement guidelines on prescription drug labeling, promotional materials, and direct-to-consumer advertising.
GxP and Compliance Frameworks
Documentation tied to Good Practices (GMP, GCP, GLP) regulations and corporate compliance programs to meet global audit and inspection standards.
Industries & Stakeholders We Serve
Sesen supports a wide range of organizations involved in the creation, interpretation, and enforcement of medical and pharmaceutical legislation. Our specialized translation services help stakeholders maintain regulatory compliance, mitigate legal risks, and ensure clear communication across jurisdictions.
National and Regional Health Authorities
Accurate translations of health laws, directives, and cross-border policies to support public health initiatives and legislative harmonization.
Regulatory Affairs Departments
Multilingual support for managing submission-ready documentation, legislative analysis, and compliance reporting across global markets.
Legal and Compliance Teams in Pharmaceutical and Biotech Companies
High-precision translations of regulatory texts, labeling laws, and patent-related legislation to ensure internal compliance and minimize enforcement risks.
International and U.S. Government Agencies (e.g., WHO, EMA, NIH)
Translation support for multinational health programs, clinical research regulations, and funding compliance documentation involving NIH, EMA, WHO, and other global health authorities.
Government Contractors and Policy Consultants
Scalable translation solutions for firms supporting government tenders, public health projects, and legislative drafting in life sciences.
Legal Firms Specializing in Health and Drug Policy
Support for multilingual legal research, legislative reviews, and documentation for litigation, compliance audits, and regulatory advocacy.
Translation Challenges We Solve
Medical and pharmaceutical legislation demands precise, context-aware translation that aligns with both legal and regulatory expectations. At Sesen, we specialize in overcoming the complex linguistic and compliance challenges that arise when working with high-stakes legislative content in the life sciences sector.
Terminological Accuracy in Legal and Regulatory Language
We ensure consistent use of legal and scientific terminology through curated glossaries, bilingual style guides, and subject matter expert (SME) review to avoid ambiguity or misinterpretation.
Multilingual Harmonization for Cross-Border Legislation
We help clients align legislative translations across multiple jurisdictions, ensuring consistency in language, structure, and interpretation across EU member states, APAC markets, and beyond.
Maintaining Legal Meaning Across Jurisdictions
Our translators are trained to preserve the intent and enforceability of legal texts while adapting them for linguistic, cultural, and regulatory differences in target countries.
Adherence to Region-Specific Formatting and Referencing Conventions
We localize document structures to comply with the formatting requirements of health authorities such as the EMA, FDA, PMDA, and NMPA, including article numbering, citation formatting, and annex labeling.
Navigating Evolving Legislative Frameworks
We track and incorporate updates from major regulatory shifts, such as Brexit, EU MDR/IVDR transitions, and EMA’s relocation, ensuring all translations reflect current legislative frameworks and interpretations.
Our Translation Process
Sesen follows a specialized translation workflow designed to meet the precision, confidentiality, and regulatory alignment required for medical and pharmaceutical legislation. Each step is engineered to minimize risk, maintain legal integrity, and support seamless regulatory submission.
Regulatory–Linguistic Review
Every medical and pharmaceutical legislation document undergoes dual review by a professional legal translator and a subject matter expert (SME) in life sciences to ensure the highest level of terminological accuracy and contextual appropriateness.
Terminology Management
We develop and maintain custom bilingual glossaries and terminology databases to ensure consistency in legal and regulatory language across all documents and updates.
In-Country Review (Optional)
For jurisdiction-specific validation, we coordinate with local reviewers, national health authorities, or regulatory consultants to incorporate local legal nuances and country-specific requirements.
Formatting for Submission
Our team adapts translations to meet the strict structural and formatting guidelines required by agencies such as the EMA, FDA, PMDA, and NMPA, including referencing protocols, annex structures, and citation rules.
Secure Delivery
Final files are delivered via encrypted channels and managed under ISO 17100, ISO 13485, and ISO 9001–certified workflows to ensure confidentiality, version control, and audit readiness.
Certifications & Compliance
Sesen adheres to the highest quality and data protection standards to support the accurate and secure translation of medical and pharmaceutical legislation. Our processes are built to meet the rigorous expectations of global health authorities and regulatory bodies.
ISO 17100 – Translation Services
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.
ISO 13485 – Medical Device Quality Systems
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.
ISO 9001 – Quality Management
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.
Regulatory Submission Expertise
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.
GDPR and HIPAA-Compliant Processes
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.
Expert-Driven Translation Enhanced by Advanced Tools
Sesen combines human subject matter expertise with advanced tools to deliver accurate, regulation-ready translations of medical and pharmaceutical legislation. Our approach ensures consistency, efficiency, and full traceability without compromising quality.
Translation Memory for Consistency Across Updates
We leverage translation memory (TM) technology to maintain uniform terminology and phrasing across recurring content, supporting faster updates and reduced review cycles.
AI-Assisted Terminology Validation
Intelligent terminology tools flag inconsistencies and ensure alignment with approved glossaries and legal references. We do not use raw machine translation for legislative content.
CMS and Document Management System Integrations
Seamless integration with content management systems (e.g., Veeva Vault, SharePoint) to streamline file transfers, version control, and review workflows.
Digital Repository for Version Control and Traceability
A secure, centralized system ensures all project files are versioned, auditable, and accessible to authorized stakeholders for regulatory oversight and historical reference.
Success Stories and Use Cases
Sesen has delivered accurate, regulation-aligned translations for leading organizations involved in health legislation and pharmaceutical compliance. Our proven track record demonstrates our ability to manage high-volume, high-stakes projects across jurisdictions.
Regulatory Harmonization of Drug Safety Laws Across 12 EU Countries
Translated and aligned pharmacovigilance and drug safety regulations to support a pan-European compliance initiative, ensuring consistency with EMA guidance and national regulatory frameworks.
Translation of Public Health Legislation for Africa-Based Pharmaceutical NGO
Provided multilingual translations of national health laws and public policy frameworks to support regulatory capacity building and healthcare access across multiple African nations.
Emergency Legislative Update Translation During a Public Health Crisis
Delivered rapid, high-accuracy translations of emergency health regulations and legal directives during the COVID-19 pandemic to enable timely implementation of public health measures.
Multilingual Review of Labeling Law Revisions for a Global Top-10 Pharma Company
Supported a global pharmaceutical manufacturer in translating and reviewing revised drug labeling laws across more than 20 markets, ensuring alignment with new regulatory requirements and multilingual labeling standards.
Frequently Asked Questions
What is the difference between legal and regulatory translation in pharmaceuticals?
Legal translation focuses on contracts, policies, and statutory texts, while regulatory translation involves documents submitted to health authorities such as the EMA, FDA, PMDA, or NMPA. Both require high linguistic precision, but regulatory translation demands alignment with evolving submission requirements and scientific context.
How do you handle jurisdiction-specific terminology?
We maintain custom glossaries built with input from subject matter experts and legal reviewers in each target market. Our translators are trained in regional regulatory language, and we offer in-country review options to validate terminology based on local legal interpretations.
Can you support translations for regional health authorities outside the U.S. and EU?
Yes. Sesen supports translations for global and regional health authorities, including those in Asia-Pacific (e.g., NMPA, HSA), Latin America (e.g., ANVISA, COFEPRIS), and Africa. We adapt content to meet the linguistic and regulatory expectations of each jurisdiction.
How do you maintain accuracy when laws are updated or revised?
We use translation memory tools and centralized terminology databases to track updates and apply consistent changes across related documents. Our workflows include version control, legal-linguistic review, and re-validation to ensure all updates are accurate and compliant.
What file formats and submission types do you support?
We work with all major file formats used in legislative and regulatory workflows, including Word, PDF, XML, Excel, InDesign, and eCTD-compatible formats. We also support formatting for electronic submissions and structured content delivery platforms.