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life-sciences-translation-services

Why Life Sciences Translations Require Specialized Expertise

Translating life sciences content demands more than language proficiency. It requires deep domain knowledge, regulatory awareness, and linguistic precision to meet the rigorous standards of global health authorities.

Inaccurate translations can lead to misinterpretation of medical information, risking patient safety and causing regulatory delays. Sesen adheres to ISO 17100 and ISO 13485 standards to support compliance with FDA, EMA, PMDA, and other international agencies.

Life sciences materials often contain dense scientific terminology, clinical data, and technical documentation. Our professional native linguists are trained in pharmacology, biotechnology, medical devices, and regulatory science to ensure accurate, context-specific translation.

Successfully launching products in global markets requires consistent multilingual documentation, from clinical trial protocols to patient labeling. Sesen delivers language solutions that support international submissions, product rollouts, and market access strategies across 150+ languages.

Our Areas of Expertise

Sesen provides specialized translation solutions across the full spectrum of life sciences sectors. Our linguists combine subject matter expertise with regulatory fluency to support global communications, product approvals, and market success.

Accurate translations of drug development documents, labeling, CMC content, and regulatory filings for global submission and commercialization.

Tailored language solutions for genomics, cell and gene therapy, biosimilars, and molecular diagnostics, with support for emerging technologies and modular content reuse.

Translation and formatting of IFUs, technical manuals, software UIs, and packaging to meet MDR, IVDR, and FDA requirements.

Support for patient-facing materials, hospital protocols, EHR documentation, and multilingual communication tools for clinical care environments.

Full linguistic support across clinical trial phases, including protocols, ICFs, IRB submissions, patient diaries, and adverse event reporting.

Translation services for eCTD modules, regulatory correspondence, and agency-requested revisions, with built-in linguistic QA and traceability.

Multilingual translation of population health documents, disease prevention campaigns, and healthcare policy across global jurisdictions.

Localization of digital platforms, mobile apps, wearable tech interfaces, and telehealth systems, ensuring usability and regulatory compliance. Explore our Digital Health and mHealth Localization Services to support connected care across global markets.

Document Types We Translate

Sesen translates a wide range of highly regulated and technically complex life sciences documents to support global compliance, clinical success, and patient communication. Every file undergoes rigorous linguistic and quality review to ensure scientific accuracy and regulatory readiness.

Protocol documents, informed consent forms, and related trial materials translated to support global study start-up, ethics approval, and participant comprehension.

Translation of investigator brochures (IBs), DSURs, and SUSARs with strict adherence to pharmacovigilance and GCP standards.

Multilingual versions of patient guides, instructions, recruitment materials, and consent documentation written in plain language and culturally adapted.

Translation and DTP formatting of outer packaging, carton labels, leaflets, and prescribing information in compliance with FDA, EMA, and country-specific regulations.

Localized instructions for use, product manuals, and device labeling that meet MDR, IVDR, and ISO 13485 documentation requirements.

Multilingual submission modules, response letters, and agency correspondence prepared for global filing in eCTD and paper-based formats. Learn more about our Regulatory Submission Formatting Services for structured, agency-ready documents.

Translation of standard operating procedures, quality system records, and chemistry, manufacturing, and controls documentation for audits and inspections.

Accurate, publication-ready translations of peer-reviewed journal content, slide decks, and LMS training materials authored by field experts.

Quality, Compliance, and Certifications

Sesen delivers life sciences translations with precision, regulatory alignment, and full quality assurance. Our certified processes and specialized linguist teams help clients meet global regulatory requirements while ensuring data integrity and patient safety.

Our workflows follow ISO 17100 standards, covering linguist qualifications, revision protocols, and project traceability to ensure high-quality translation outcomes.

We support medical device manufacturers with translations aligned to ISO 13485, ensuring documentation readiness for audits, CE marking, and market entry.

Sesen follows strict data protection protocols to safeguard patient and sponsor information across all projects, meeting HIPAA and GDPR requirements for confidentiality and security.

Translations are validated by native-speaking professionals in the target market to ensure medical accuracy, cultural relevance, and compliance with local regulatory language.

Our linguists are not only native professionals but also domain experts in therapeutic areas such as oncology, rare disease, diagnostics, and regulatory science.

AI-Supported Human Translation

Sesen integrates advanced language technologies and the latest AI innovations with expert human expertise to deliver high-quality, scalable translation solutions for life sciences. Our intelligent workflows improve turnaround time, ensure consistency, and support regulatory compliance without sacrificing scientific accuracy or contextual relevance.

We leverage AI to assist human translators with pre-processing, terminology suggestions, and automated consistency checks, ensuring efficiency while maintaining expert oversight.

For large-scale projects, our certified linguists post-edit AI-generated translations to meet regulatory and scientific accuracy standards, reducing turnaround time while preserving quality.

Client-specific TMs and terminology databases are securely stored and applied across projects to maintain linguistic consistency, reduce duplication, and support faster delivery.

We support modular dossier strategies by enabling efficient translation of reusable components across multiple markets and submission rounds, improving speed and reducing cost.

SesenGPT automates terminology extraction, in-context validation, and quality checks, providing a second layer of AI review to ensure precision across critical documentation.

Multilingual Support and Global Coverage

Sesen provides end-to-end language support for life sciences organizations operating in global markets. Our multilingual solutions help clients meet country-specific regulatory requirements and ensure effective communication across regions and audiences.

We offer professional translation services in over 150 languages, including all major regulatory jurisdictions and emerging markets, with specialized linguistic support for complex therapeutic areas.

Our native linguists reside in target markets and possess deep knowledge of local healthcare regulations, cultural nuances, and terminology, ensuring translations are both scientifically accurate and locally appropriate.

We support global operations across all major regions, enabling seamless submission and communication for clients engaged in multi-country clinical trials, product launches, and regulatory filings.

Our in-house desktop publishing team formats translated documents in accordance with regulatory and branding standards, maintaining layout integrity across languages and scripts, including right-to-left and double-byte characters.

How We Work: A Streamlined, Compliant Process

Sesen follows a structured, transparent process designed to meet the quality and compliance demands of life sciences organizations. Our workflows ensure accuracy, efficiency, and accountability at every stage of the project lifecycle.

Each engagement begins with a detailed project briefing led by a dedicated account manager who serves as your single point of contact throughout the project.

We assign professional native linguists with proven expertise in the relevant therapeutic area and regulatory environment, ensuring precision and contextual accuracy.

All content undergoes a multi-step process that includes initial translation, bilingual editing, QA checks, and final formatting to meet linguistic and technical standards.

For high-risk or regulatory-critical content, we offer back translation and reconciliation workflows to support validation and alignment with source materials.

Clients receive regular updates and performance metrics. We also offer flexible scheduling for project review meetings to ensure alignment and transparency.

Case Study Snapshot

Helping a Global Pharma Company Submit Multilingual eCTD Files Across 12 Markets

Challenge

A leading pharmaceutical company needed to submit eCTD documentation to the EMA and local authorities across 12 language markets within an accelerated regulatory timeline.

Sesen implemented a proactive terminology management strategy by extracting a glossary of high-impact terms from the source content using AI-assisted tools and subject matter review. These terms were translated and submitted for client approval prior to full content translation, significantly streamlining the workflow. This approach reduced review cycles, eliminated repeated clarification requests, and accelerated overall delivery. Combined with our dedicated linguist teams, translation memory integration, and parallel processing model, we successfully met the 96-hour turnaround requirement while maintaining quality and compliance.

The client achieved first-pass approval from all regulatory agencies. Our solution reduced internal review cycles, minimized costs, and enabled simultaneous multi-country submissions without delays or compliance issues.

Frequently Asked Questions

Sesen specializes exclusively in life sciences, combining certified translation workflows, domain-specific linguists, and AI-enhanced QA. Our deep understanding of regulatory and scientific content allows us to deliver accurate, compliant translations with faster turnaround and fewer review cycles.

We follow ISO 17100 and ISO 13485 standards, assign qualified linguists with therapeutic-area expertise, and implement multi-step QA processes. Our translations meet the requirements of global regulatory bodies including the FDA, EMA, NMPA, PMDA, and Health Canada.

Yes. We offer expedited workflows for time-sensitive projects such as clinical trial start-ups, safety reporting, and regulatory responses. Our scalable linguist teams and real-time project management systems enable high-quality delivery on compressed timelines.

We work with pharmaceutical and biotechnology companies, medical device manufacturers, CROs, regulatory consultancies, digital health platforms, and hospital networks. Our clients range from early-stage startups to global enterprises.

Yes. Our multilingual desktop publishing (DTP) team formats translated content across all regulatory and patient-facing materials, ensuring visual consistency and compliance with local formatting standards for every language.

We provide back translation, reconciliation, and cognitive debriefing services to support IRB submissions, patient-facing materials, and other high-risk content. These services meet the expectations of ethics committees and global health authorities.

Partner with Sesen for Trusted Life Sciences Translation Services

Accelerate global approvals and ensure patient safety with Sesen’s certified, domain-specialized translation solutions for pharmaceuticals, biotech, medical devices, and clinical research.

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