Regulatory Accuracy
Scientific, medical, technical, and regulatory meaning must remain precise across languages. Numerical content, dosage information, references, claims, and safety-critical language require particular attention.
Regulatory Translation Services for Life Sciences
Support global submissions, health authority communication, labeling, quality systems, safety programs, and regulatory lifecycle updates with specialized life sciences translation across 150+ languages.
Sesen combines professional native life sciences linguists, controlled terminology, structured quality review, secure workflows, and AI-assisted technologies to help pharmaceutical, biotechnology, medical device, CRO, and healthcare organizations manage regulated multilingual content with greater consistency and control.
ISO 17100 Certified
ISO 9001:2015 Certified
ISO 13485:2016 Certified
150+ Languages
Professional Native Life Sciences Linguists
Secure AWS Infrastructure
Regulatory Content Must Stay Controlled Across Languages
Regulatory content rarely exists as a single document. The same product, study, claim, safety statement, manufacturing term, or approved phrase can appear across submission modules, labeling, clinical documentation, quality systems, safety reports, and market-specific updates.
As that content moves across languages and regulatory cycles, translation quality depends on more than sentence-level accuracy. It requires control over terminology, references, versions, document relationships, and review decisions.
Terminology Consistency
Product terminology, study language, CMC terms, adverse event terminology, approved labeling language, and recurring regulatory phrases should remain aligned across connected documents.
Document Control
Drafts, revisions, amendments, reviewer comments, and country-specific adaptations need clear version awareness so multilingual content remains connected to the correct source.
Delivery Readiness
Translation, review, QA, and formatting should reflect how the content will actually be used—whether for submission, authority response, labeling, inspection, quality operations, or post-approval maintenance.
REGULATORY LIFECYCLE
Regulatory Translation Across the Product Lifecycle
Global regulatory translation does not end when an application is submitted. Multilingual content evolves throughout development, authority review, approval, commercialization, safety monitoring, and ongoing product maintenance.
01
Prepare
Build multilingual readiness with regulatory documentation, terminology resources, reference materials, target-language and market requirements, and review requirements.
02
Submit
Translate dossiers, CTD and eCTD content, applications, technical documentation, labeling components, and supporting materials.
03
Respond
Support health authority questions, requests for information, deficiency responses, attachments, meeting materials, and regulatory correspondence.
04
Approve & Launch
Prepare prescribing information, SmPCs, patient information, packaging, labels, IFUs, and country-specific approved product content.
05
Operate
Maintain SOPs, QMS documentation, validation materials, CAPA content, audits, training, and other controlled operational content.
06
Monitor
Support pharmacovigilance, adverse event content, periodic safety reports, risk-management materials, and post-market safety communication.
07
Maintain
Manage variations, amendments, labeling revisions, manufacturing changes, safety updates, product extensions, and recurring lifecycle content.
One regulatory lifecycle. Many interconnected documents. A controlled multilingual workflow.
Regulatory Documents and Content We Translate
Sesen supports regulatory translation across pharmaceutical, biotechnology, medical device, clinical research, quality, and post-market environments. Workflows are adapted to the content type, target market, intended use, file format, risk level, and review requirements.
Submissions & Dossiers
- IND, NDA, BLA, ANDA, and MAA documentation
- CTD and eCTD content
- IMPDs and supporting materials
- Regional and administrative documentation
- Amendments, variations, and supplements
- Medical device 510(k), PMA, technical, and market-specific regulatory content
Clinical & Scientific Regulatory Content
- Clinical study reports
- Clinical trial protocols
- Investigator brochures
- Clinical summaries and overviews
- Nonclinical documentation
- Scientific and statistical supporting documentation
CMC & Manufacturing
- Quality and CMC modules
- Manufacturing-process documentation
- Specifications and analytical methods
- Stability documentation
- Validation materials
- Control strategies and supporting technical documentation
Labeling & Product Information
- Prescribing information
- Summaries of Product Characteristics
- Patient information leaflets
- Package inserts and medication guides
- Labels, packaging, warnings, and precautions
- IFUs and post-approval product-information updates
Quality & Compliance Documentation
- Standard operating procedures
- Work instructions and QMS documentation
- CAPA documentation
- Deviations and change controls
- Validation records
- Audit, inspection, training, and compliance content
Pharmacovigilance & Safety
- AE and SAE documentation
- ICSRs and SUSAR-related content
- Case narratives
- DSURs, PSURs, and PBRERs
- Risk management plans
- Safety communications and post-market surveillance documentation
CTD and eCTD Translation for Global Regulatory Submissions
Regulatory submissions bring together scientific, clinical, quality, administrative, and product information that must remain aligned as one body of evidence.
For multilingual CTD and eCTD programs, quality depends not only on translating each document correctly, but also on maintaining terminology, references, study identifiers, product information, formatting, and prior translation decisions across interconnected modules and subsequent updates.
MODULE 1
Regional & Administrative Information
Region-specific administrative content, application materials, product information, forms, labeling, correspondence, and supporting documents.
MODULE 2
CTD Summaries
Quality, nonclinical, and clinical overviews and summaries with terminology aligned to the detailed evidence presented elsewhere in the dossier.
MODULE 3
Quality / CMC
Drug substance and drug product information, manufacturing processes, specifications, analytical procedures, validation, stability, and related quality documentation.
MODULE 4
Nonclinical Study Reports
Pharmacology, pharmacokinetic, toxicology, and other nonclinical documentation used within the submission package.
MODULE 5
Clinical Study Reports
Clinical study documentation and supporting evidence with attention to study terminology, endpoints, safety language, references, and cross-document consistency.
Terminology Governance
Reference Alignment
Version Management
Formatting & Structure
Translation Memory
Expert Review & QA
Health Authority Communication and Regulatory Responses
Submission is often the beginning of an ongoing review process. Regulatory affairs teams may need to respond to questions, requests for additional information, deficiencies, clarification requests, labeling comments, or other authority communication—sometimes under demanding timelines and across multiple internal and regional stakeholders.
Response Content
- Health authority questions
- Requests for information
- Deficiency letters and sponsor responses
- Clarification packages and attachments
Review Coordination
- Meeting materials and correspondence
- Local affiliate communication
- Updated supporting documentation
- Urgent and rolling response packages
Using established glossaries, translation memory, prior submission content, product references, and reviewer decisions helps responses remain aligned with the multilingual documentation that preceded them.
Regulatory Affairs Translation ServicesAuthority Question
Response Content
Multilingual Review
Final Delivery
Maintain continuity with the original submission
Terminology, references, study identifiers, product language, and reviewer decisions should remain consistent as authority interactions create new multilingual content.
Regulatory Labeling and Product Information Across Global Markets
Product information must communicate approved content accurately while meeting the linguistic and operational requirements of each target market. Sesen helps life sciences organizations maintain consistency across interconnected labeling components while supporting review, formatting, and recurring updates.
Drug Labeling & Product Information
Prescribing information, SmPCs, patient information leaflets, package inserts, medication guides, warnings, contraindications, approved safety statements, and product-information updates.
Packaging & Artwork Content
Carton and container text, package labels, artwork text, symbols and accompanying language, layout-sensitive content, and market variants. In-context review can help identify truncation, misplaced text, formatting inconsistencies, and other layout issues.
Medical Device Labeling & IFUs
Instructions for use, device labels, warnings and precautions, technical documentation, packaging content, software-related user content, and recurring product updates.
Lifecycle Labeling Updates
Multilingual revisions supported through translation memory, terminology assets, reference materials, version-aware workflows, and review processes that distinguish new content from previously approved language.
Translation for Quality Systems and Regulated Operations
Regulatory translation extends beyond submissions and product labeling. Life sciences organizations rely on controlled documentation every day to manage processes, training, manufacturing, quality events, audits, inspections, and continuous improvement.
When those operations span countries and languages, internal documentation needs the same discipline applied to external regulatory content.
Controlled Procedures
SOPs, work instructions, process documents, policies, manuals, and related controlled materials with consistent procedural terminology.
Quality Management Documentation
Quality manuals, QMS procedures, CAPAs, deviations, investigations, change controls, and corrective or preventive actions.
Validation & Manufacturing
Validation protocols and reports, manufacturing documentation, specifications, process instructions, and controlled technical content.
Audit & Inspection Readiness
Audit materials, inspection-related documents, findings, responses, evidence packages, and quality records requiring accurate multilingual communication.
Training & Implementation
Regulated training materials aligned with the underlying procedures, terminology, and operational instructions used by employees and partners.
Pharmacovigilance and Safety Translation
Drug safety content presents a distinct set of multilingual challenges. Case narratives may be time-sensitive. Periodic safety reports recur across the product lifecycle. Medical terminology must remain consistent, and new information may need to be incorporated without changing the meaning of prior safety language.
Case Intake & Safety Reporting
Adverse event reports, serious adverse event reports, individual case safety reports, SUSAR-related documentation, CIOMS forms, case narratives, follow-up information, and case updates.
Aggregate & Periodic Safety Reporting
DSURs, PSURs, PBRERs, annual safety reports, line listings, safety summaries, and benefit-risk updates.
Risk Management & Post-Market Safety
Risk management plans, risk-minimization materials, safety variations, signal-related documentation, post-marketing surveillance content, and safety data exchange documentation.
Safety Communication
Safety information for health authorities, healthcare professionals, affiliates, investigators, partners, and other stakeholders with controlled terminology and narrative accuracy.
Terminology Governance Across the Regulatory Lifecycle
Keep product, clinical, CMC, labeling, safety, and quality terminology consistent as regulated content moves across documents, languages, markets, and revisions. A regulatory program may involve hundreds or thousands of interconnected content elements, with the same approved terms recurring across submissions, clinical documents, labeling, safety reports, quality systems, and post-approval updates.
Sesen treats terminology as a managed regulatory asset rather than a project-by-project afterthought.
Glossaries
Termbases
Translation Memory
Style Guides
Client References
Reviewer Feedback
A Controlled Workflow for Regulatory Translation
Every regulatory translation program is different, but disciplined execution follows a common principle: quality controls should begin before translation and continue through final delivery.
01
Project & Content Assessment
Review content types, intended use, target languages and markets, regulatory context, source files, references, timelines, expected updates, and review requirements.
02
Terminology & Reference Alignment
Integrate client glossaries, prior approved translations, product terminology, translation memory, style guides, submission references, labeling references, and market-specific preferences.
03
Specialized Translation
Professional native linguists are selected according to language, subject-matter experience, document type, and intended use, with approved terminology and translation memory integrated into the workflow.
04
Independent Linguistic Review
Translated content is reviewed for accuracy, completeness, terminology, grammar, consistency, context, references, and adherence to project instructions.
05
Regulatory & Technical QA
Technology-assisted checks help identify potential issues involving terminology, numbers, units, dates, tags, formatting, repeated content, omissions, and cross-document inconsistencies.
06
Formatting & Final Delivery
Files are prepared for the required delivery environment, including layout-sensitive content where applicable, followed by final QA against the approved content and project requirements.
For ongoing programs: Client / Affiliate Review → Feedback Reconciliation → Terminology Update → Translation Memory Update
HUMAN EXPERTISE + TECHNOLOGY
Professional Regulatory Expertise Enhanced by AI
AI can accelerate how multilingual content is processed, checked, reused, and managed at scale. For regulated life sciences content, however, speed alone is not the objective.
Scientific meaning, regulatory context, approved terminology, document relationships, patient and product safety, and final quality still require professional judgment. Sesen combines professional life sciences expertise with SesenGPT-enabled workflows, translation memory, terminology intelligence, automated QA, and structured human review.
Explore SesenGPT
Translation Memory
Reuse previously reviewed content where appropriate across revisions and related documents.
Terminology Intelligence
Identify and apply approved scientific, clinical, product, safety, and regulatory terminology.
SesenGPT-Assisted Workflows
Support suitable drafting and workflow efficiency within controlled translation processes.
AI-Assisted Quality Assurance
Help identify potential issues involving terminology, numbers, units, dates, formatting, and consistency.
Professional Human Review
Qualified linguists and reviewers remain responsible for evaluating meaning, context, terminology, and final linguistic quality.
150+ LANGUAGES
Multilingual Support for Global Regulatory Programs
Global regulatory programs rarely follow a single-language, single-market path. Sesen provides translation and localization support across 150+ languages for regulatory submissions, product information, authority communication, quality documentation, safety content, and lifecycle updates.
Multi-Market Programs
Coordinate multiple target languages through centralized project management and shared quality controls.
Country & Language Variants
Manage market-specific language preferences without losing alignment with core approved content.
Asian-Language Workflows
Support Chinese, Japanese, Korean, and other Asian languages with appropriate linguistic and formatting expertise.
Right-to-Left Languages
Manage Arabic, Hebrew, and other right-to-left content with attention to document presentation and layout.
Multilingual Formatting
Support translated tables, graphics, structured files, publishing formats, and layout-sensitive regulated documentation.
Local Review Coordination
Incorporate affiliate, in-country, or client reviewer feedback into controlled workflows and reusable linguistic assets.
Quality and Security for Regulated Multilingual Content
Regulatory teams need confidence not only in the translated words, but also in the process surrounding them. Sesen combines ISO-certified quality processes, regulated-content controls, professional native life sciences linguists, secure project handling, terminology governance, and documented QA workflows.
Translation Services Quality
Structured translation-service processes incorporating qualified linguists, translation, independent review, project management oversight, and quality control.
Quality Management
Quality management principles applied across project intake, resource management, workflow control, issue management, communication, and continuous improvement.
Medical Device Quality Management
Quality practices relevant to multilingual medical device documentation including IFUs, labeling, packaging, software, safety content, and regulated product documentation.
Controlled Content Handling
Sesen uses controlled access and secure handling for sensitive life sciences documents, references, and project materials, supported by AWS-hosted infrastructure.
Documented Review & Delivery
Defined QA stages, reviewer accountability, version control, and delivery records give organizations visibility into how regulated multilingual content was produced and reviewed.
Terminology & Version Control
Shared language assets, approved terminology, reference materials, and version-aware workflows help maintain continuity across recurring regulatory content.
Regulatory Translation for Life Sciences Organizations
Sesen supports organizations across the life sciences ecosystem with translation workflows aligned to the content they create and the markets they serve.
Pharmaceutical Companies
Translation across drug development, submissions, CMC, labeling, pharmacovigilance, quality operations, and lifecycle maintenance.
Biotechnology Companies
Specialized support for complex scientific, clinical, regulatory, and product content involving novel therapies and evolving development programs.
Medical Device & IVD Manufacturers
Translation for regulatory documentation, technical files, labeling, IFUs, quality systems, software, safety information, and product updates.
Contract Research Organizations
Scalable multilingual support across sponsor programs, clinical documentation, regulatory activity, safety content, site communication, and submission workflows.
Healthcare & Digital Health Organizations
Translation and localization for regulated healthcare, clinical, software, and compliance-related content across global environments.
Regulatory & Public Health Organizations
Specialized multilingual support for regulatory, scientific, healthcare, and public-health communication where precision and controlled terminology matter.
Why Life Sciences Teams Choose Sesen for Regulatory Translation
Regulated multilingual programs require subject-matter expertise, repeatable controls, and the ability to maintain language decisions across documents and over time.
Life Sciences Specialization
Sesen is built around pharmaceutical, biotechnology, medical device, CRO, healthcare, and other regulated life sciences content—not general-purpose translation alone.
Professional Native Life Sciences Linguists
Linguists are selected according to target language, subject expertise, document type, and project requirements.
Cross-Document Terminology Control
Glossaries, translation memory, product references, style guides, and client-specific linguistic rules help maintain consistency across connected regulatory content.
Structured Quality Workflows
Translation, independent review, QA, project oversight, and final delivery are managed through defined quality processes appropriate for regulated content.
Scalable Multilingual Operations
Sesen supports projects ranging from individual regulatory documents to complex, recurring programs involving multiple content streams, countries, and languages.
Human Expertise + Intelligent Technology
Professional linguistic expertise is supported by SesenGPT, terminology intelligence, translation memory, automation, and AI-assisted QA—not displaced by them.
Explore Specialized Regulatory Translation Services
When your program requires deeper support in a particular regulatory workflow, Sesen provides specialized services across the regulatory content lifecycle.
Regulatory Submission Translation Services
Dossiers, applications, supporting documentation, amendments, response packages, and global regulatory filings.
Explore service →CTD & eCTD Translation Services
Translation across CTD modules, structured submission content, terminology, references, revisions, and lifecycle updates.
Explore service →Regulatory Affairs Translation Services
Support for regulatory affairs teams managing submissions, authority communication, labeling updates, safety documentation, and lifecycle activity.
Explore service →Regulatory Compliance Translation Services
Translation for controlled compliance, quality, audit, inspection, and regulated operational content.
Explore service →Regulatory Submission Formatting
Technical formatting and document preparation to support multilingual regulatory submission workflows.
Explore service →CMC Document Translation Services
Specialized translation for Chemistry, Manufacturing, and Controls documentation used across pharmaceutical regulatory programs.
Explore service →Drug Labeling & Packaging Translation
Prescribing information, SmPCs, PILs, package inserts, packaging, and regulated product information.
Explore service →Pharmacovigilance Translation Services
Adverse event content, safety narratives, periodic reports, risk-management materials, and global safety communication.
Explore service →IFU Translation Services
Medical device instructions for use, safety information, product documentation, and multilingual market requirements.
Explore service →Regulatory Translation Services FAQs
Answers to common questions about regulatory translation workflows, document coverage, quality controls, terminology, AI-assisted processes, and global language support.
What are regulatory translation services?
Regulatory translation services support the multilingual translation, review, and management of content used in regulatory submissions, product approvals, health authority communication, labeling, quality systems, inspections, safety reporting, and ongoing product lifecycle activities. Because related regulatory documents frequently reuse scientific, medical, product, and safety terminology, effective regulatory translation also requires terminology governance, version awareness, cross-document consistency, and structured quality review.
What types of regulatory documents does Sesen translate?
Sesen supports CTD/eCTD content, regulatory applications and dossiers, IND/NDA/BLA/ANDA/MAA materials, clinical and nonclinical documentation, CMC content, health authority correspondence, drug labeling, IFUs, SOPs, QMS documentation, validation materials, audit and inspection content, pharmacovigilance documentation, and other regulated life sciences materials.
Does Sesen translate CTD and eCTD submissions?
Yes. Sesen supports translation across CTD and eCTD content, including regional and administrative materials, summaries, CMC documentation, nonclinical reports, clinical documentation, labeling, and related submission-support content. Workflows can incorporate terminology management, translation memory, reference alignment, version control, formatting support, linguistic review, and QA across interconnected submission documents.
Can Sesen support regulatory submissions and health authority responses?
Yes. Sesen supports both planned submission content and subsequent multilingual regulatory communication, including authority questions, requests for information, deficiency responses, clarification packages, supporting attachments, and related correspondence. Prior approved translation, terminology, and reference materials can help maintain continuity between the original submission and later responses.
How does Sesen maintain terminology consistency across regulatory documents?
Sesen uses client-approved glossaries, terminology databases, translation memory, style guides, product references, legacy translations, reviewer feedback, and project-specific linguistic rules. These resources can be applied across submissions, CMC content, clinical documents, labeling, quality documentation, safety content, and subsequent updates so recurring terminology remains controlled throughout the program.
Does Sesen translate SOPs and quality-system documentation?
Yes. Sesen supports SOPs, work instructions, quality manuals, QMS documentation, CAPAs, deviations, change controls, validation materials, audits, inspections, training, and other controlled quality and compliance content. Version-aware workflows and translation memory can also support recurring revisions.
Can Sesen translate drug labeling, packaging, and IFUs?
Yes. Sesen translates prescribing information, SmPCs, patient information leaflets, package inserts, medication guides, labels, packaging, warnings, device labeling, IFUs, and other regulated product information. Sesen can also support layout-sensitive review and recurring multilingual updates.
Does Sesen provide pharmacovigilance translation?
Yes. Sesen supports pharmacovigilance and drug safety content including AE and SAE documentation, ICSRs, SUSAR-related content, case narratives, DSURs, PSURs, PBRERs, RMPs, safety communications, and post-marketing materials.
How does Sesen use AI for regulatory translation?
Sesen uses AI-assisted technologies to support appropriate translation workflows, terminology identification, content reuse, and quality checks. For regulated content, AI operates within a controlled workflow that includes professional human expertise. Qualified linguists and reviewers remain responsible for evaluating context, meaning, terminology, and final linguistic quality.
Can Sesen support urgent or rolling regulatory translation projects?
Yes. Sesen can structure project management, translation, review, and QA around urgent, rolling, and recurring regulatory requirements. The appropriate workflow depends on document type, volume, language combination, intended use, deadline, and required quality controls.
What languages does Sesen support for regulatory translation?
Sesen supports regulatory translation in more than 150 languages, including major European, Asian, Latin American, Middle Eastern, and other global market languages.
Can Sesen format translated regulatory documents for submission or review?
Yes. Sesen supports multilingual document formatting and technical preparation for regulatory content, including layout-sensitive files, structured documents, tables, graphics, and other formats where translated content must remain usable within the intended regulatory workflow.
Regulatory Submission FormattingMove Global Regulatory Content Forward With Confidence
Whether you are preparing a submission, responding to health authority questions, updating product labeling, managing quality documentation, supporting drug safety operations, or maintaining multilingual content across the product lifecycle, Sesen can help you build the right regulatory translation workflow.
Bring together professional life sciences linguists, controlled terminology, translation memory, structured review, secure workflows, and AI-assisted quality technologies in one multilingual program designed around your content, markets, and regulatory needs.