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Why Pharmaceutical Translation Matters

Why Pharmaceutical Translation Matters

The pharmaceutical industry operates in a highly regulated, global environment where every document must be precise and compliant across multiple languages. Accurate translation is essential to meet the stringent requirements of agencies such as the FDA, EMA, PMDA, NMPA, and ANVISA. Even small errors can result in regulatory rejection, costly resubmissions, delayed approvals, and potential risks to patient safety.

As the industry shifts toward patient-centered communication, there is increasing demand for clear, culturally adapted content that meets plain language and readability standards. Patient information leaflets, informed consent forms, and digital health applications must be written in language that patients can understand while maintaining scientific and regulatory accuracy.

Speed-to-market is another critical factor in today’s competitive landscape. Pharmaceutical companies that can deliver multilingual dossiers, labeling, and safety reports efficiently are better positioned to secure approvals, protect their market share, and launch therapies ahead of competitors. High-quality pharmaceutical translation is no longer optional, it is a strategic requirement for global success.

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Who We Support

Who We Support

Sesen partners with stakeholders across the pharmaceutical ecosystem to deliver accurate, regulator-ready translations that align with global compliance standards.

We support regulatory affairs teams, labeling and packaging groups, pharmacovigilance and drug safety units, medical affairs, and commercial divisions. Each group requires precise multilingual communication, from dossier submissions and safety narratives to promotional materials and HCP training.

Our solutions extend to CROs and research networks that manage multinational clinical trials. We provide translation of study protocols, informed consent forms, case report forms, and other critical documents that enable smooth trial operations across regions.

We collaborate with creative and medical communications agencies that develop patient information leaflets, physician marketing content, payer dossiers, and digital campaigns. Our expertise ensures that messaging remains accurate, culturally relevant, and compliant with industry guidelines.

We adapt to the needs of our clients, whether for long-term multilingual programs, accelerated support during peak submission periods, large-scale labeling updates, or urgent safety reporting spikes. Our scalable model allows us to integrate seamlessly into existing workflows while maintaining quality and compliance at every stage.

Documents We Translate for Pharmaceuticals

Sesen provides comprehensive pharmaceutical translation services across the entire product lifecycle. Our linguists specialize in highly regulated content where precision, compliance, and readability are critical to regulatory approval and patient safety.

We translate protocols, toxicology and pharmacology reports, and Investigator Brochures that support early-stage research and enable global collaboration.

Our services cover clinical study protocols, Informed Consent Forms (ICFs), Case Report Forms (CRFs/eCRFs), patient diaries, electronic patient-reported outcomes (ePROs), and site training materials. Each translation is adapted for accuracy, consistency, and patient comprehension across multiple regions.

We support Investigational New Drug (IND), New Drug Application (NDA), Biologics License Application (BLA), Marketing Authorization Application (MAA), and Clinical Trial Application (CTA) submissions. Our team handles eCTD Modules 1–5, regulatory correspondence, and deficiency responses with workflows that include back-translation for high-risk content to meet agency expectations.

Our expertise includes Individual Case Safety Reports (ICSRs/E2B[R3]), case narratives, Development Safety Update Reports (DSUR), Periodic Safety Update Reports (PSUR/PBRER), and Risk Management Plans (RMP). We ensure alignment with MedDRA and WHO-Drug dictionaries to support accurate safety data reporting worldwide.

We translate Chemistry, Manufacturing, and Controls (CMC) documentation, including batch records, validation protocols, Certificates of Analysis (CoAs), SOPs, and quality manuals. These materials are vital for demonstrating product quality and compliance in global submissions.

Our linguists translate drug inserts, Summary of Product Characteristics (SmPC), Prescribing Information (PI), Patient Information Leaflets (PILs), Instructions for Use (IFUs), and carton/leaflet artwork. We provide compliant formatting for EMA QRD templates, SPL/IDMP attributes, and emerging EU electronic product information (ePI) requirements.

We support healthcare professional (HCP) marketing content, payer dossiers, and eLearning programs for sales representatives and medical staff, ensuring technical accuracy while adapting to local market requirements.

Our services extend to pharma portals, patient-facing applications, and clinical trial software localization. We provide in-context translation and functional QA to ensure usability and compliance across multilingual digital platforms.

Workflow and Controls

How We Work: Workflow and Controls

Sesen applies a structured workflow designed to meet the strict quality, compliance, and security requirements of global pharmaceutical organizations. Each project is managed through validated processes that ensure accuracy, consistency, and regulatory readiness.

All projects begin with secure file transfer, confidentiality agreements, and scoping to define language pairs, timelines, and deliverables. Our AWS-hosted translation management system supports GDPR and HIPAA alignment for sensitive data.

We build and maintain pharmaceutical-specific glossaries and style guides to ensure consistency across regulatory submissions, labeling, and safety reporting. Terminology management is supported by AI-assisted extraction and client validation.

Translations are performed by linguists with proven experience in regulatory, clinical, and pharmacovigilance content. Subject matter expertise ensures that technical terminology and context remain accurate across multiple regions.

Every translation undergoes an independent linguistic review for accuracy, readability, and regulatory compliance. Critical data such as dosage, adverse events, and safety information are cross-checked against source materials.

For regulatory-critical documents such as informed consent forms, patient materials, and labeling, we offer back-translation workflows to verify accuracy and identify discrepancies before submission.

When required, content is reviewed by in-country subject matter experts or client teams to confirm cultural adaptation and regulatory acceptability in local markets.

Final deliverables are evaluated using linguistic quality assurance frameworks with severity-based error categorization. This ensures transparency, traceability, and continuous quality improvement.

Our DTP team formats documents in EMA QRD templates, SPL, IDMP, and other regulator-specific layouts. Visual accuracy is maintained across languages, including double-byte and right-to-left scripts.

Completed translations are delivered in formats compatible with eCTD publishing systems and regulatory submission workflows. This ensures seamless integration with sponsor and CRO systems and supports on-time approvals.

Quality & Compliance Standards

Sesen’s pharmaceutical translation services are built on internationally recognized quality frameworks and compliance protocols that meet the demands of regulators and sponsors worldwide.

Our operations are certified to ISO 17100 for translation services, ISO 13485 for medical device and life sciences content, and ISO 9001 for quality management. These certifications ensure structured processes, documented procedures, and measurable quality outcomes.

We apply Good Practice (GxP) principles across translation projects, including complete audit trails, change-control mechanisms, and version management. This approach supports traceability and regulator readiness for submissions and inspections.

All projects are managed on secure AWS-hosted systems with encryption in transit and at rest. We apply role-based access controls and confidentiality safeguards aligned with GDPR and HIPAA requirements, ensuring that sensitive patient and regulatory data remains protected at every stage.

For patient-facing content such as informed consent forms and labeling, we implement plain language adaptation and readability checks. Content is reviewed against frameworks such as Flesch-Kincaid and regional health literacy guidelines to improve comprehension and support patient engagement without compromising scientific accuracy.

Advanced Human Translation Solutions

Sesen combines proven linguistic expertise with advanced translation technologies to deliver accurate, compliant, and regulator-ready pharmaceutical content. Our approach enhances consistency, reduces turnaround times, and supports cost efficiency while keeping human expertise at the core.

We leverage Translation Memory (TM), terminology databases, and pharma-specific glossaries to maintain consistency across large volumes of content, from regulatory submissions to pharmacovigilance reporting.

All projects are managed in a secure, AWS-hosted TMS with dedicated client portals. This environment ensures GDPR and HIPAA alignment while providing clients with real-time visibility into project status, terminology, and deliverables.

We support in-context review for drug labels, packaging artwork, and software user interfaces. This process allows linguists to validate accuracy directly within the final format, reducing errors and rework in high-stakes materials.

When appropriate, we deploy hybrid workflows that combine human translation with machine translation post-editing (MTPE). Every output undergoes expert review to ensure the quality required for regulatory-critical and patient-facing documents.

Our QA tools automatically check numbers, terminology, formatting, and consistency across multilingual datasets. These checks add another layer of accuracy, helping regulatory, labeling, and safety teams avoid costly errors.

Supported Formats & Systems

Sesen provides pharmaceutical translation services that are fully compatible with the file formats and systems used across the industry. Our teams handle complex structured content and design files while maintaining compliance with regulatory publishing requirements.

We work with a wide range of formats including XML and SGML files for structured documentation, Structured Product Labeling (SPL), Adobe InDesign (IDML/INDD), JSON and XLIFF for digital content, Microsoft 365 files, and CTD/eCTD-ready submissions. This ensures seamless integration with regulatory publishing tools and global dossier standards.

Our translators and production specialists are experienced with leading platforms such as Veeva PromoMats for medical and promotional content, Argus Safety for pharmacovigilance outputs, and Adobe Creative Suite for packaging and artwork. We also support integration with clinical trial management systems and eClinical platforms to streamline translation workflows for multinational studies.

By aligning with industry-standard formats and technologies, Sesen delivers submission-ready translations that reduce rework, accelerate approvals, and improve operational efficiency for pharmaceutical companies and their partners.

Languages & Global Reach

Sesen provides pharmaceutical translation services in more than 150 languages, supporting drug development and regulatory submissions across North America, Europe, Asia-Pacific, Latin America, and the Middle East. Our global reach allows sponsors and CROs to manage multinational programs efficiently and consistently.

We deliver translations that meet the requirements of leading regulatory agencies including the FDA in the United States, EMA in the European Union, PMDA in Japan, MFDS in South Korea, ANVISA in Brazil, and NMPA in China. This expertise ensures that dossiers, labeling, and safety reports meet local submission standards without costly delays.

Our teams support orphan drug applications and rare disease clinical trials, where precise patient-facing materials and multilingual submissions are critical for approval under accelerated pathways.

We have extensive experience translating and formatting drug labeling in compliance with EMA QRD templates, SPL and IDMP standards, and emerging electronic product information (ePI) frameworks. Our in-country experts adapt content for local markets while preserving scientific accuracy and compliance.

By combining regional expertise with global language coverage, Sesen enables pharmaceutical companies to expand access to therapies worldwide and meet the complex demands of international regulators.

Case Studies & Impact

Case Studies & Impact

Sesen has a proven track record of delivering high-quality pharmaceutical translations that accelerate regulatory approvals and support global market access. Our case studies highlight the impact of accurate, regulator-ready translation in high-stakes programs.

We translated a full New Drug Application (NDA) dossier for an oncology therapy submitted to the US FDA. The project covered hundreds of thousands of words across clinical, CMC, and labeling modules. Our structured translation and review process enabled the sponsor to meet its submission deadline and achieve regulatory approval without delays caused by language discrepancies.

A leading pharmaceutical company engaged Sesen to translate and update product labeling and packaging for a cardiovascular drug portfolio. Our team delivered compliant translations in alignment with EMA QRD templates, covering 25 European markets. Centralized terminology management and in-context artwork review reduced turnaround times and ensured consistency across all languages.

For a global safety monitoring program, Sesen provided ongoing translation of Individual Case Safety Reports (ICSRs), case narratives, and Development Safety Update Reports (DSURs) in over 20 languages. By aligning translations with MedDRA coding and regional pharmacovigilance guidelines, we supported timely submission of safety data to regulators worldwide.

Through projects like these, Sesen demonstrates how precise, compliant pharmaceutical translation strengthens regulatory outcomes, enhances patient safety, and accelerates the international availability of critical therapies.

Related Services

Sesen’s pharmaceutical translation services are closely connected to our broader life sciences expertise. Explore related services that ensure consistency, compliance, and efficiency across the full spectrum of drug development and commercialization:

  • Clinical Trial Translation – Translation of protocols, informed consent forms, case report forms, and patient-facing materials to support global clinical studies.
  • Pharmacovigilance Translation – Accurate, regulator-ready translations of ICSRs, safety narratives, DSURs, and PSUR/PBRERs in compliance with MedDRA and international safety reporting requirements.
  • IFU (Instructions for Use) Translation – Multilingual IFU translations for drug delivery systems, devices, and combination products, formatted for regulatory submission and patient usability.
  • Label Review & In-Context QA – Specialist review of drug labeling, packaging artwork, and electronic product information (ePI) to ensure accuracy, compliance, and cultural relevance in every market.
  • Linguistic Validation – Rigorous validation of patient-reported outcome (PRO) instruments and clinical outcome assessments (COAs) to meet regulatory expectations and support reliable trial data.
  • Regulatory Translation – Translation of regulatory dossiers, correspondence, and eCTD modules to meet FDA, EMA, PMDA, NMPA, and other agency requirements for approval.

By linking pharmaceutical translation to these related services, Sesen provides an integrated approach that helps pharmaceutical companies streamline global submissions, safeguard patient safety, and accelerate time-to-market.

FAQs

Sesen translates the full range of pharmaceutical content, including clinical trial protocols, informed consent forms, regulatory dossiers (IND, NDA, BLA, MAA, CTA), labeling and packaging, pharmacovigilance reports, Chemistry Manufacturing and Controls (CMC) documentation, and patient-facing materials.

Our processes are aligned with the requirements of FDA, EMA, PMDA, NMPA, MFDS, and ANVISA. We use ISO-certified quality management systems, regulatory templates such as eCTD and QRD, and subject matter experts to ensure translations meet local submission standards.

Yes. We offer back-translation for regulatory-critical and patient-facing documents such as informed consent forms, labeling, and safety narratives. We also provide linguistic validation for patient-reported outcomes (PROs) and clinical outcome assessments (COAs) to meet regulatory and scientific requirements.

Sesen maintains scalable linguist teams and follow-the-sun project management, allowing us to handle accelerated timelines and urgent submissions. We deliver rolling batches for large volumes and provide submission-ready files formatted for eCTD publishing.

All projects are managed in secure AWS-hosted environments with encryption in transit and at rest. We apply GDPR and HIPAA alignment, role-based access controls, and confidentiality agreements to safeguard proprietary, clinical, and patient data.

Power Your Global Pharmaceutical Operations with Accurate Translation

Sesen partners with pharmaceutical leaders to deliver multilingual documents that meet regulatory requirements, accelerate approvals, and protect patient safety across global markets.

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