Real-World Translation Success in Life Sciences

Explore how Sesen supports global regulatory, clinical, and commercial initiatives through high-quality language solutions.

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Featured Case Studies

Explore how Sesen delivers regulatory-grade translation and localization solutions for leading life sciences organizations. Each case study highlights real-world challenges, our strategic approach, and measurable results.

Each case study includes:

Client Type – Global pharmaceutical companies, biotech innovators, clinical research organizations (CROs), and public health agencies
Challenge – Tight regulatory timelines, multilingual rollout demands, labeling compliance, or complex subject matter
Solution – Customized workflows combining ISO-certified processes, expert linguists, in-country review, and AI-assisted MTPE using SesenGPT
Results – Faster time to market, increased accuracy, improved global compliance, and reduced localization costs

Sample Case Studies

Multilingual Vaccine Submission to WHO and National Authorities

Client: Global Pharma | Region: Global

Challenge: Urgent need for simultaneous submission to WHO and 15+ national regulatory bodies
Solution: Scalable translation workflow with centralized QA and in-country linguistic validation
Results: Submission completed within regulatory deadlines; multilingual consistency ensured across all dossiers

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Linguistic Validation of COA Instrument for Global Oncology Trial

Client: Leading CRO | Region: Global

Challenge: Multi-country clinical trial requiring validated COA translations in 25 languages under tight startup timelines
Solution: Full linguistic validation workflow including forward/back translation, cognitive debriefing, and clinician review
Results: On-time delivery of 25 regulator-ready COA instruments; improved patient comprehension and global data consistency

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Rapid PMDA Submission for an Oncology Trial Sponsor

Client: Mid-size Biotech | Region: Japan

Challenge: Compressed timeline for investigational drug application requiring Japanese translations of trial protocols and CMC data
Solution: Hybrid translation with expert post-editing; close collaboration with local regulatory consultants
Results: On-time submission to PMDA; no rework or language-related findings

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Labeling Translation & QA for 15 Languages Across Global Markets

Client: Global Medical Device Manufacturer | Region: EU, APAC, LATAM

Challenge: Multilingual labeling updates required for IVD product line expansion with tight market launch timelines
Solution: Centralized workflow with label reuse automation, multilingual DTP, and in-context linguistic QA
Results: Delivered regulator-ready labels in 15 languages on time; reduced QA review cycles by 35% with zero translation-related findings

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IFU Localization for a Class III Medical Device

Client: U.S. MedTech Company | Region: EU

Challenge: Complex, highly technical IFU requiring localization under MDR compliance
Solution: Native linguists with device expertise; harmonized terminology across product families
Results: Fully compliant EU submission package; translation approved without revisions

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Global Patient Engagement Campaign in 20+ Languages

Client: Biopharma Marketing Team | Region: Global

Challenge: Patient education materials for clinical trials across culturally diverse markets
Solution: Transcreation and regional content adaptation with patient readability scoring
Results: Increased engagement and enrollment across multilingual audiences; brand consistency maintained

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Cognitive Debriefing in 22 Languages for a Phase III Clinical Trial on HAE

Client: Global Biopharmaceutical Company | Region: Global

Challenge: Validate a patient-reported outcome (PRO) instrument across 22 languages and diverse age groups for regulatory inclusion
Solution: Cognitive debriefing interviews using age-specific protocols and culturally adapted probes, conducted in accordance with ISPOR and FDA COA guidelines
Results: Regulator-approved PRO instruments deployed in 30+ trial sites worldwide; ensured cross-cultural equivalence and content validity across all patient populations

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Regulatory Documentation for a Biosimilars Launch

Client: Emerging Biotech | Region: EU, LATAM

Challenge: Multi-jurisdiction dossier translations for biosimilar approval
Solution: Dedicated project team with regulatory SMEs and terminology harmonization
Results: Regulatory approval timelines met across target markets

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Digital Health App Localization for EU MDR Compliance

Client: HealthTech Company | Region: EU

Challenge: Localization of UI strings, user guidance, and privacy policies in 10+ EU languages
Solution: TMS-integrated localization pipeline with automated QA and legal review
Results: Compliant app deployment across EU markets; multilingual UX aligned with regulatory standards

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Why Sesen

Sesen is a trusted language partner exclusively serving the life sciences industry. Our proven success across complex translation projects is driven by deep subject matter expertise, regulatory alignment, and scalable global delivery.

Life Sciences–Exclusive Focus

We specialize in pharmaceuticals, biotechnology, medical devices, CROs, and public health—ensuring every project is handled by experts with domain-specific knowledge.

Regulatory-Grade Quality Processes

Our workflows are certified to ISO 17100, ISO 13485, and ISO 9001 standards, enabling consistent, audit-ready translations for EMA, FDA, PMDA, and other health authorities.

Scalable Global Workflows

Whether supporting a multinational product launch or regional labeling updates, our agile teams manage multilingual projects across 150+ languages with precision and speed.

AI-Assisted Translation with SesenGPT

We integrate advanced AI tools like SesenGPT to enhance linguistic consistency, accelerate turnaround, and support machine translation post-editing (MTPE) for regulatory and clinical content.

Professional Native Linguists & Dedicated Project Managers

All translations are performed by professional native linguists with subject matter expertise and supported by dedicated project managers who oversee quality, timelines, and compliance.

Ready to Achieve Global Success with Sesen?

Discover how our life sciences–exclusive translation solutions drive global success across pharma, biotech, medical devices, and CROs.