Discovery & Preclinical
Pharmacology, toxicology, nonclinical study reports, pharmacokinetic and pharmacodynamic content, research summaries, and scientific documentation.
Life Sciences SpecializationSpecialized pharmaceutical and regulated-content expertise
ISO-Certified Quality SystemsISO 17100 · ISO 9001 · ISO 13485
Professional Native LinguistsResources aligned with content and subject matter
Terminology GovernanceControlled multilingual terminology and translation memory
150+ LanguagesCoordinated multilingual delivery across global markets
Translation Across the Pharmaceutical Product Lifecycle
Pharmaceutical content changes continuously as a drug moves from research and clinical development through regulatory review, market launch, safety monitoring, and lifecycle management. Sesen connects specialized translation with terminology, review, validation, version control, and program management across that journey.
Clinical Development
Protocols, investigator brochures, informed consent, clinical reports, site materials, patient content, eCOA/ePRO, and study communications.
Regulatory & CMC
CTD/eCTD content, CMC documentation, clinical and nonclinical summaries, agency correspondence, and supporting submission materials.
Labeling & Global Launch
Prescribing information, SmPCs, PILs, medication guides, package inserts, labeling, packaging, artwork, and launch-related materials.
Safety & Lifecycle Management
Adverse-event narratives, ICSRs, CIOMS content, DSURs, PSURs/PBRERs, risk-management documentation, and safety communications.
Medical Affairs & Commercialization
Medical information, scientific publications, congress content, field medical materials, training, market access, patient, HCP, and digital content.
Terminology Governance
Translation Memory
Professional Review
Quality Validation
Version Control
Program Management
Specialized Translation for Pharmaceutical Content
Different pharmaceutical teams create different content for different audiences and stages of the product lifecycle. Sesen brings these workflows together so approved terminology, reference content, translation assets, and review decisions can remain aligned across the program.
Clinical Research & Development
Protocols, amendments, investigator brochures, informed consent forms, case report forms, clinical study reports, site documentation, patient materials, eCOA/ePRO instruments, training, and trial communications.
Clinical Trial Translation ServicesRegulatory Submissions & CMC
CTD/eCTD documentation, clinical and nonclinical summaries, CMC content, quality documentation, health-authority correspondence, briefing documents, responses to questions, and post-approval updates.
Regulatory Translation ServicesDrug Labeling & Product Information
Prescribing information, SmPCs, PILs, medication guides, inserts, cartons, labels, packaging, artwork, and subsequent labeling updates with terminology and version alignment.
Drug Labeling & Packaging TranslationPharmacovigilance & Drug Safety
Safety narratives, case content, ICSRs, CIOMS forms, DSURs, PSURs/PBRERs, risk-management materials, post-market surveillance content, and safety communications.
Pharmacovigilance Translation ServicesMedical & Scientific Communications
Medical affairs, medical information, scientific publications, advisory-board materials, congress content, field medical communications, and healthcare-professional materials.
Medical Affairs Translation ServicesTraining, Digital & Commercial Content
Training programs, eLearning, product websites, patient portals, applications, presentations, multimedia, market-access materials, disease-awareness content, and global launch communications.
Pharmaceutical Language SolutionsRISK-APPROPRIATE DELIVERY
The Right Workflow for Every Pharmaceutical Content Type
A regulatory dossier, an informed consent form, an adverse-event narrative, a package insert, and an internal training module have different audiences, risk profiles, timelines, and review requirements. Sesen aligns the multilingual workflow with the content and its intended use.
Regulatory & Submission-Critical Content
Qualified life sciences linguists translate with approved terminology, reference material, translation memory, and project instructions. Independent review and final QA can verify source fidelity, terminology, completeness, numbers, formatting, and consistency.
Clinical & Patient-Facing Content
Clinical content may require additional methodologies such as reconciliation, back translation, cognitive debriefing, clinician review, sponsor review, or in-country review depending on the content, audience, and program requirements.
Recurring Pharmaceutical Content
Controlled terminology, translation memory, reviewer preferences, approved reference content, and repeatable QA processes create continuity across versions instead of treating each new file as an isolated project.
Suitable AI-Assisted Content
Where content type, project requirements, and risk level make AI assistance appropriate, SesenGPT can support controlled translation and validation while qualified professionals remain central to review and final quality.
Pharmaceutical Expertise Behind Every Translation
Medical fluency alone is not enough. A linguist working on an oncology protocol needs a different knowledge profile from one reviewing CMC documentation, a safety narrative, patient labeling, or an MSL training deck.
Specialized Life Sciences Linguists
Professional native-language resources are aligned with pharmaceutical subject matter, language pair, content type, and project requirements—not selected on language availability alone.
Independent Linguistic Review
When the workflow calls for independent review, a separate qualified linguist checks accuracy, terminology, readability, completeness, consistency, and project instructions.
Dedicated Project & Program Management
Project teams coordinate languages, files, timelines, terminology, reviewer feedback, source updates, priorities, and delivery phases across complex pharmaceutical engagements.
Multilingual File Expertise
Scientific tables, figures, captions, structured documents, labeling artwork, presentations, XML-based content, Office files, and multilingual layouts receive production attention as well as linguistic review.
Professional Expertise, Enhanced by SesenGPT
AI can create meaningful efficiencies in pharmaceutical translation when it is used within a controlled workflow appropriate to the content. SesenGPT supports selected translation, terminology, content-reuse, and validation tasks while professional life sciences linguists remain central to context, review, and final quality.
Explore SesenGPTProfessional
ExpertiseCentral to final quality
ExpertiseCentral to final quality
Selective AI Assistance
AI assistance can support suitable pharmaceutical content when the content risk, project scope, and review requirements allow.
Approved Content Reuse
Translation memory helps identify and reuse previously reviewed translations instead of unnecessarily retranslating established content.
AI-Assisted Validation
Automated checks can help surface potential terminology, numerical, formatting, completeness, and consistency issues for human review.
Expert Human Validation
Professional life sciences linguists interpret meaning, resolve ambiguity, evaluate context, and remain responsible for final quality decisions.
TERMINOLOGY GOVERNANCE
Keep Pharmaceutical Terminology Consistent Across Languages and Programs
One drug program can generate terminology across protocols, submissions, CMC documentation, labeling, pharmacovigilance, medical affairs, training, and commercial content. Sesen treats terminology as a managed multilingual asset that can follow the program across documents, languages, versions, and lifecycle stages.
CONTROLLED LANGUAGE ASSETOne Approved Term.
Many Connected Workflows.
Many Connected Workflows.
Program terminology can be maintained once and applied across related content instead of being re-decided document by document.
Build Program Terminology
Identify scientific, clinical, product, regulatory, safety, and company-specific terms.
Apply Approved Language
Give translators and reviewers a shared reference for preferred multilingual terminology.
Connect With Translation Memory
Pair approved terms with previously reviewed segments for consistent content reuse.
Capture Reviewer Decisions
Feed accepted sponsor, affiliate, or in-country review decisions into future work.
Clinical
Regulatory
Labeling
Safety
Medical Affairs
Commercial
Quality Controls for Complex Pharmaceutical Content
Pharmaceutical translation quality extends beyond fluent language. Scientific meaning, terminology, numerical data, cross-references, tables, figures, formatting, and completeness all affect whether multilingual content can be used confidently.
Linguistic Accuracy
Meaning, grammar, syntax, tone, readability, source fidelity, and appropriate scientific or medical register.
Pharmaceutical Terminology
Approved product terminology, clinical language, scientific terms, regulatory expressions, safety wording, abbreviations, and client preferences.
Numbers, Doses & Units
Doses, units, percentages, measurements, study data, concentrations, and other numerical content receive dedicated cross-checking attention.
Tables, Figures & Cross-References
Captions, legends, labels, footnotes, section references, tables, figures, and structured document elements are checked for alignment and completeness.
Completeness & Formatting
Untranslated text, missing content, formatting inconsistencies, file issues, and other production risks are checked before delivery.
AI-Assisted QA Under Human Oversight
SesenGPT-enabled validation can add another quality layer by flagging issues for professional evaluation rather than replacing expert review.
Multilingual Quality ReviewExample quality validation workflow
CONTENT UNDER REVIEW
Administer 2.5 mg once daily. See Table 4 for dose-adjustment criteria.
Approved terminologyverified
Dose and unitverified
Table cross-referenceverified
Independent reviewcomplete
REGULATORY CONTENT
Translation Support for Global Pharmaceutical Regulatory Programs
Global regulatory translation requires scientific accuracy, controlled terminology, document consistency, version awareness, and formatting discipline. Sesen supports pharmaceutical content prepared for submissions and health-authority interactions across major global markets.
CTD & eCTD Content
Support for region-specific content, summaries, CMC and quality content, nonclinical documentation, clinical documentation, and related submission files.
Health-Authority Communications
Requests for information, responses to questions, briefing materials, correspondence, meeting content, regulatory updates, and other submission-lifecycle communications.
Product Information & Linguistic Review
Coordinated multilingual review, approved terminology, formatting, and version control for labels, inserts, product information, and supporting content.
Common Technical DocumentMultilingual support across structured pharmaceutical submission content
MODULE 1Region-Specific Administrative Information
MODULE 2CTD Summaries
MODULE 3Quality / CMC
MODULE 4Nonclinical Study Reports
MODULE 5Clinical Study Reports
ENTERPRISE DELIVERY
From One Regulatory Document to a Global Multilingual Program
Source documents change. Protocols are amended. Regulatory questions arrive. New markets are added. Labels are updated. Safety content recurs. Sesen supports both individual projects and long-term programs designed around this continuing pharmaceutical content lifecycle.
Centralized Program Management
Coordinate languages, documents, schedules, linguistic resources, reviewer feedback, priorities, and delivery requirements through one managed workflow.
Translation Memory & Content Reuse
Reuse approved translations where appropriate to improve consistency across related documents and recurring updates while reducing unnecessary retranslation.
Version-Aware Delivery
Maintain alignment across amendments, revisions, labeling updates, regulatory responses, and subsequent releases as source documents change.
Rolling & Phased Translation
Prioritize critical content and deliver in controlled phases when regulatory, clinical, safety, or launch timelines require parallel workstreams.
Reviewer Coordination
Structure feedback from sponsor reviewers, affiliates, subject-matter experts, and in-country teams so approved decisions can inform future content.
Multilingual Formatting & Production
Coordinate translated content through final file preparation, DTP, structured formats, labeling layouts, presentations, and other delivery environments.
Pharmaceutical Translation Across Global Markets
Sesen supports pharmaceutical and broader life sciences translation across more than 150 languages. Native-language expertise is coordinated with centralized terminology, translation memory, professional review, QA, and program management so local linguistic quality does not come at the expense of global consistency.
150+ languages
Native life sciences linguists
Centralized terminology
Multilingual program management
Quality Systems for Regulated Pharmaceutical Content
Quality needs to be designed into the workflow—not added only at the end. Sesen combines certified quality systems, specialist linguistic resources, documented review processes, terminology controls, and controlled delivery practices for regulated multilingual content.
Certified translation-service processes supporting qualified linguistic resources, translation, review, and structured quality controls.
Certified quality-management processes supporting repeatability, documentation, operational control, and continuous improvement.
A formal quality-management framework supporting Sesen's broader regulated life sciences operations.
Secure Infrastructure & Controlled AccessAWS-hosted systems where applicable, controlled file access, confidentiality practices, and client-specific handling for sensitive life sciences content.
Documented ReviewIndependent review, QA, reviewer accountability, and project documentation as required by the engagement.
Traceable Content DecisionsTerminology, versions, reviewer feedback, and approved language carried forward across related work.
CASE STUDIES
Pharmaceutical Translation in Practice
See how Sesen applies specialized linguists, terminology governance, structured review, validation, and multilingual coordination to complex pharmaceutical and clinical programs.
REGULATORY SUBMISSIONS
Multilingual Regulatory Submission for Global Biopharma
A global biopharmaceutical organization needed coordinated translation for a complex, multi-region regulatory program. Sesen supported CTD/eCTD-related content, terminology alignment, native-language expertise, review workflows, and evolving source materials across multiple languages.
VACCINES
Multilingual Vaccine Submission Across Global Authorities
A global pharmaceutical company required time-sensitive translation of CTD content, SmPCs, patient information, IFUs, labeling, and supporting materials across multiple languages and jurisdictions. Sesen coordinated specialized linguists, terminology, review, and layered QA.
LINGUISTIC VALIDATION
Linguistic Validation for a Global Oncology Clinical Trial
A leading CRO supporting a pharmaceutical oncology study needed linguistic validation of a Clinical Outcome Assessment instrument in 25 languages. Sesen coordinated forward translation, reconciliation, back translation, cognitive debriefing, clinical review, and final harmonization.
Explore Related Pharmaceutical Expertise
Global pharmaceutical programs often require several specialized language workflows working together. Explore focused Sesen capabilities for the content and teams involved across the drug lifecycle.
Insights for Global Pharmaceutical Content Teams
Explore practical guidance for pharmaceutical, clinical, regulatory, labeling, terminology, and multilingual program teams as life sciences content operations become more connected.
AI & VALIDATION
AI Translation Validation for Life Sciences
Explore how expert review, terminology controls, translation memory, and structured QA can help evaluate AI-generated multilingual content.
Explore AI Translation Validation CLINICAL & REGULATORYClinical & Regulatory Knowledge
Practical guidance on clinical trial translation, regulatory submissions, labeling, terminology, multilingual quality, and regulated workflows.
Explore Clinical & Regulatory Knowledge WORKFLOW KNOWLEDGELife Sciences Translation Knowledge Base
Guidance on translation and review workflows, hybrid translation, MTPE, back translation, reconciliation, in-country review, DTP, and terminology.
Explore the Knowledge Base TERMINOLOGYPharmaceutical Terminology & Style Guidance
Reference materials for pharmaceutical terminology, controlled language, dosage formatting, abbreviations, regulatory phrasing, and consistency.
Explore Pharmaceutical Style GuidancePharmaceutical Translation Services FAQs
Answers to common questions about pharmaceutical translation workflows, terminology, regulatory content, linguistic validation, AI assistance, and global program delivery.
Sesen translates pharmaceutical content across clinical development, regulatory affairs, CMC, labeling, pharmacovigilance, medical affairs, training, digital content, and commercialization. Common documents include protocols, investigator brochures, informed consent forms, CTD/eCTD content, CMC documentation, regulatory correspondence, SmPCs, PILs, package inserts, labeling, adverse-event narratives, ICSRs, DSURs, PSURs/PBRERs, medical information, scientific materials, and patient-facing content.
Sesen uses professional native life sciences linguists and aligns resources with the subject matter, language pair, content type, and project requirements. Pharmaceutical work may require expertise in clinical research, regulatory affairs, CMC, pharmacovigilance, medical affairs, labeling, or patient communication, so resource selection goes beyond language fluency alone.
Yes. Sesen pharmaceutical workflows can include independent linguistic review by a separate qualified linguist. The review checks accuracy, terminology, readability, completeness, consistency, and alignment with project requirements before final QA and delivery.
Yes. Sesen supports CTD/eCTD translation and multilingual regulatory documentation, including region-specific materials, summaries, CMC content, nonclinical and clinical documentation, labeling, and supporting regulatory files. The workflow is configured around the source content, target markets, languages, and client requirements.
Sesen combines terminology management, multilingual glossaries, translation memory, reference content, and reviewer feedback to maintain approved language across related documents and updates. These resources can follow a drug program from clinical development through regulatory submission, labeling, safety, medical affairs, and commercialization.
Sesen uses AI selectively through SesenGPT. For suitable content, AI can support controlled translation, terminology application, translation-memory reuse, and validation. Professional life sciences linguists remain central to review and final quality, particularly for regulated, patient-facing, safety-related, and submission-critical content.
Yes. Sesen provides linguistic validation for COA, eCOA, ePRO, PRO, ClinRO, ObsRO, PerfO, questionnaires, scales, diaries, and other clinical instruments. Depending on the methodology, workflows may include forward translation, reconciliation, back translation, cognitive debriefing, clinician review, harmonization, and supporting documentation.
Yes. Sesen supports both defined projects and recurring multilingual programs. Ongoing workflows can include centralized terminology, translation-memory management, source-version handling, phased delivery, multilingual scheduling, reviewer coordination, in-country review, formatting, QA, and controlled reuse of approved content.
Sesen supports pharmaceutical and broader life sciences translation across more than 150 languages, with professional native-language resources and coordinated multilingual program management for major markets worldwide.
For a defined project, submit your source files, required languages, timing, and project information through Sesen's quote process. For large submissions, recurring pharmaceutical programs, AI-enabled workflows, or projects requiring consultation before scoping, contact Team Sesen to review the requirements.
Bring Greater Control to Your Global Pharmaceutical Translation Program
Whether you need translation for one critical document or coordinated multilingual support across clinical development, regulatory submissions, labeling, pharmacovigilance, medical affairs, and commercialization, Sesen can build a workflow around your content, languages, timelines, quality requirements, and review process.