Meet Sesen at DIA 2025 in Washington, D.C.
Join us June 15–19 at Booth #2013 to explore global clinical and regulatory language solutions.
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 AuthoritiesClient: Global Pharma | Region: Global
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
Rapid PMDA Submission for an Oncology Trial SponsorClient: Mid-size Biotech | Region: Japan
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
Labeling Translation & QA for 30+ Markets in ParallelClient: Global Medical Device Manufacturer | Region: EU, APAC, LATAM
Client: Global Medical Device Manufacturer | Region: EU, APAC, LATAM
- Challenge: Coordinated multilingual labeling updates following product line expansion
- Solution: Label reuse automation, multilingual DTP, and in-context linguistic QA across regions
- Results: On-schedule global launch with zero regulatory delays; reduced QA cycles by 35%
IFU Localization for a Class III Medical DeviceClient: U.S. MedTech Company | Region: EU
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
Global Patient Engagement Campaign in 20+ LanguagesClient: Biopharma Marketing Team | Region: Global
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
Regulatory Documentation for a Biosimilars LaunchClient: Emerging Biotech | Region: EU, LATAM
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
Digital Health App Localization for EU MDR ComplianceClient: HealthTech Company | Region: EU
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
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.
