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regulatory-submission-translation-case-study

Overview

For global biopharmaceutical companies, regulatory submission translation is a critical component of successful market authorization. Submitting dossiers to agencies such as the EMA, FDA, and PMDA requires more than linguistic accuracy. It demands regulatory fluency, therapeutic expertise, and strict adherence to formatting and compliance standards. As multilingual filings often occur in parallel across regions, translation workflows must align seamlessly with medical writing timelines and in-country review requirements.

This case study outlines how Sesen supported a top global biopharma company with end-to-end translation for a multi-language regulatory submission. Through a combination of subject matter expertise, structured CTD and eCTD workflows, and quality control aligned with ISO standards, Sesen helped accelerate submission readiness across multiple markets.

Client Background

The client is a leading global biopharmaceutical company focused on advancing therapies in oncology and rare diseases. With operations spanning North America, Europe, and Asia-Pacific, the company manages complex regulatory activities across multiple health authorities, including the EMA, FDA, and PMDA.

For this project, the client was preparing a simultaneous regulatory submission for an oncology product across three major regions. The submission included an initial New Drug Application (NDA) and Marketing Authorization Application (MAA), supported by comprehensive preclinical and clinical documentation. The multilingual requirement and compressed timeline introduced added complexity, particularly for translating CTD Modules 2 through 5 in alignment with region-specific compliance standards.

Project Scope

Sesen was engaged to support a global regulatory submission involving a full Common Technical Document (CTD) package, including Modules 2 through 5, the Investigator’s Brochure, and the clinical Briefing Package. The source content was authored in English and required high-accuracy translations into French, German, Japanese, Korean, and Simplified Chinese to meet EMA, PMDA, and NMPA requirements.

The total volume exceeded 120,000 words across more than 85 documents. This included clinical summaries, preclinical data, risk management plans, and product information templates. The project was executed over a four-week period to meet parallel submission deadlines across multiple markets.

Key stakeholders included the client’s Regulatory Affairs and Medical Writing teams, with active collaboration from in-country reviewers to validate scientific accuracy and terminology consistency. Sesen’s team worked in close coordination with the client’s global submission calendar to align with internal quality review milestones and region-specific formatting standards.

Challenges

The project presented several critical challenges common in global regulatory language services. The client faced tight submission deadlines for both EMA and FDA filings, requiring multilingual translations to be completed within a compressed timeframe and aligned across regions.

Each target language had to meet parallel delivery timelines, placing pressure on coordination across translation, review, and quality assurance. The documents contained complex scientific and regulatory terminology that required expert medical translators with deep therapeutic knowledge and familiarity with regulatory guidance.

In-country reviewers (ICRs) were involved in validating terminology and contextual relevance, requiring seamless integration of reviewer feedback without disrupting submission schedules. Frequent updates to the source documents, especially during the final stages, added further complexity to version control and linguistic consistency.

The project also required precise formatting for eCTD submission, with strict adherence to layout standards, section numbering, and file specifications. These formatting requirements had to be applied uniformly across all translated modules to ensure technical compliance across global health authorities.

Our Solution

  1. Expert Regulatory Translators

Sesen deployed a team of native linguists with specialized experience in regulatory medical translation and therapeutic area expertise in oncology and rare diseases. Each translator was trained in regulatory writing standards and had working knowledge of ICH guidelines, EMA and FDA expectations, and regional terminology nuances. This ensured scientific accuracy and alignment with health authority language preferences across all target markets.

  1. Modular Translation Workflow for CTD and eCTD

To support the complexity of the Common Technical Document, Sesen implemented a modular translation workflow that mirrored the CTD structure. Modules 1 through 5 were managed through parallel workstreams by document type and language. This allowed simultaneous progress across translation, review, and formatting activities while ensuring each module adhered to content hierarchy and technical formatting for eCTD submissions.

  1. Terminology Consistency with Glossaries and Style Guides

A customized bilingual glossary and style guide were developed in collaboration with the client’s medical writing and regulatory teams. Sesen leveraged existing translation memories and incorporated controlled terminology to standardize language across documents and languages. Continuous updates were made to reflect reviewer input and evolving source content, supporting both linguistic consistency and regulatory clarity.

  1. Integrated Review Process with ICR and QA

Sesen coordinated with in-country reviewers (ICRs) in each target market to ensure contextual relevance and compliance with local regulatory norms. Reviewer feedback was incorporated through a controlled versioning process. All deliverables passed through a three-tiered quality assurance workflow aligned with ISO 17100, ISO 9001, and ISO 13485 standards, covering linguistic accuracy, technical formatting, and scientific validation. Feedback from in-country reviewers was incorporated in real time.

  1. Dedicated Project Management

A dedicated project manager oversaw the entire engagement, providing weekly status updates and serving as the central point of contact. Real-time communication channels were established to address urgent source changes and ICR feedback. A secure client portal was used for document exchange, glossary collaboration, and version control, ensuring full transparency throughout the submission cycle.

Outcome and Results

Through a structured, collaborative approach and strict adherence to regulatory and linguistic standards, Sesen delivered measurable results that supported the client’s global submission strategy:

  • Delivered over 120,000 words of regulatory content in six languages within a four-week project timeline, enabling the client to meet simultaneous submission deadlines.
  • Achieved zero compliance findings across EMA, FDA, and PMDA audits, validating the accuracy and completeness of translated materials.
  • Received positive feedback from all in-country reviewers, citing consistency in scientific terminology and responsiveness to review comments.
  • Supported synchronized submissions in the United States, European Union, and Japan, allowing the client to execute a unified global launch strategy.
  • Reduced time-to-market by eliminating rework and shortening review cycles through integrated quality assurance and real-time terminology alignment.
  • Turnaround time per language averaged 5 to 7 business days per module, including ICR feedback and final formatting for eCTD compliance.

This engagement reinforced Sesen’s ability to scale multilingual regulatory translation services while maintaining scientific precision, submission readiness, and client confidence.

Document Types Translated

Sesen supported the full regulatory package with high-accuracy translations of clinical, safety, and labeling documentation required for multinational submissions. All content was aligned with CTD structure, regulatory authority guidelines, and therapeutic area terminology. Translations followed the structure outlined in our CTD and eCTD translation services.

  • Clinical Overview (Module 2.5)
    High-level clinical summary translated to reflect study design, outcomes, and product profile in accordance with ICH guidelines.
  • Summary of Clinical Efficacy (Module 2.7.3)
    In-depth translation of efficacy data, endpoints, and statistical analysis used to support market authorization.
  • Investigator’s Brochure
    Multilingual versions tailored for regulatory submission and clinical site readiness across target regions.
  • Product Information
    Including Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL), and primary and secondary packaging labels, all localized for compliance with EMA and country-specific formatting.
  • Risk Management Plans (RMPs)
    Translated with strict terminology alignment to ensure clarity in safety profiles, pharmacovigilance measures, and mitigation strategies.
  • Study Protocols and Statistical Analysis Plans (SAPs)
    Technical documentation translated to meet regulatory expectations for clinical trial design and data analysis.

Each document type underwent full quality review and formatting validation for eCTD submission compatibility across languages.

Regulatory Regions Supported

Sesen provided multilingual regulatory translation services tailored to the submission requirements of key global health authorities. Each translated document was localized in alignment with region-specific templates, regulatory expectations, and linguistic standards to ensure approval readiness.

  • EMA (Europe)
    Translations prepared in compliance with EMA’s QRD templates and country-specific language requirements for centralized and decentralized procedures.
  • FDA (United States)
    US English content aligned with FDA formatting and guidance, supporting NDA documentation and briefing materials for pre-submission meetings.
  • PMDA (Japan)
    Japanese translations validated through in-country review to meet PMDA standards for clinical data presentation, terminology, and formatting.
  • NMPA (China)
    Simplified Chinese translations localized to comply with NMPA submission guidelines, including risk documentation and product labeling.
  • ANVISA (Brazil)
    Brazilian Portuguese translations formatted to meet ANVISA’s dossier structure and technical document requirements for market registration.

Sesen’s region-specific expertise enabled seamless submission localization across major markets, helping the client meet simultaneous regulatory deadlines.

Quality and Compliance Standards

Sesen applies a rigorous quality and compliance framework to all regulatory translation projects, ensuring every deliverable meets global health authority standards and client expectations for accuracy, security, and traceability.

  • ISO-Certified Processes
    All services are delivered in accordance with ISO 17100 for translation quality, ISO 9001:2015 for quality management systems, and ISO 13485:2016 for medical device documentation. These certifications ensure consistency, traceable workflows, and validated translation procedures across all project stages.
  • Secure Data Handling and Regulatory Compliance
    Sesen adheres to secure data management protocols aligned with 21 CFR Part 11, supporting electronic records and signatures with robust confidentiality, traceability, and access controls. All file exchanges occur through encrypted platforms to safeguard regulatory documents.
  • Multi-Layered Quality Assurance Model
    Every document undergoes a structured quality assurance process involving three distinct layers: linguistic review by a second medical translator, scientific verification by subject matter experts, and formatting checks to validate compliance with CTD and eCTD submission standards.

This quality infrastructure allows Sesen to consistently deliver compliant, regulator-ready translations that support successful global submissions.

Client Feedback

“Sesen’s translation quality and responsiveness were instrumental in helping us meet tight submission timelines across three regions. Their team demonstrated a strong command of regulatory terminology and maintained accuracy across all languages, even as source documents evolved late in the process. We appreciated the clear communication, structured workflow, and commitment to delivering submission-ready translations.”

— Global Regulatory Affairs Manager, Top 20 Biopharmaceutical Company

This testimonial reflects Sesen’s ability to support complex, multi-region submissions with precision, flexibility, and subject matter expertise trusted by leading global life sciences organizations.

Why Sesen?

Sesen delivers regulatory translation services purpose-built for the life sciences sector. Our singular focus, proven expertise, and scalable infrastructure make us a trusted partner for global biopharmaceutical companies navigating complex submission pathways.

  • 100 Percent Life Sciences Focus
    Sesen specializes exclusively in life sciences translation, allowing our teams to stay current with therapeutic developments, regulatory changes, and scientific language conventions across drug development, clinical trials, and commercialization.
  • Regulatory Submission Expertise
    From CTD and eCTD document formatting to in-country review workflows, our teams are experienced in translating content for EMA, FDA, PMDA, and other global health authorities. We support NDA, MAA, IND, CTA, and post-approval updates with full compliance.
  • Scalable Multilingual Capacity
    Whether translating a single briefing book or an entire submission across ten languages, Sesen provides flexible, coordinated translation capacity supported by native-language experts and regional project teams.
  • Machine Translation Post-Editing (MTPE)
    For non-core documentation such as reference appendices or legacy data, we offer MTPE with human oversight. This approach reduces turnaround times and costs by up to 40 percent while maintaining acceptable quality for supporting documents.
  • Transparent Project Management and Client Collaboration
    Clients receive dedicated project managers, real-time progress updates, and secure access to all deliverables and glossaries. We work as an extension of your regulatory and medical writing teams to ensure alignment, accuracy, and speed.

Sesen combines regulatory fluency with scalable translation solutions to help clients meet global submission timelines with confidence.

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