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Research & Product Development
Scientific research, nonclinical studies, pharmacology, toxicology, product-development reports, and technical assessments.
Medical & Scientific Translation Services
Biologics & Biosimilar ExpertiseScientific and technical translation for complex biological products
ISO-Certified QualityStructured translation, review, and quality workflows
Expert Human ReviewProfessional life sciences linguists for regulated content
150+ LanguagesMultilingual support for development programs and global markets
Translation Across the Biologics & Biosimilar Lifecycle
Biological products generate highly connected scientific, clinical, manufacturing, regulatory, labeling, and safety content. Sesen helps global teams maintain multilingual consistency as this content moves across countries, submissions, manufacturing sites, and lifecycle updates.
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Analytical Characterization & Comparability
Structural, physicochemical, biological, and functional characterization, analytical methods, critical quality attributes, and comparative assessments.
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Clinical Development
Protocols, Investigator Brochures, informed consent, patient materials, PK/PD, immunogenicity, clinical reports, and eClinical content.
Clinical Trial Translation Services04
CMC, Manufacturing & Quality
CMC documentation, manufacturing procedures, analytical methods, specifications, validation, batch records, SOPs, and quality systems.
CMC Document Translation Services05
Regulatory Submission & Health Authority Review
BLAs, biosimilar applications, MAAs, CTD/eCTD content, briefing packages, agency correspondence, and post-approval submissions.
Regulatory Submission Translation Services06
Labeling & Product Information
Prescribing information, SmPCs, PILs, package inserts, Medication Guides, administration instructions, packaging, and labeling updates.
Labeling Translation Services07
Pharmacovigilance & Post-Market Safety
Adverse event content, safety narratives, aggregate reports, risk-management materials, safety communications, and labeling revisions.
Pharmacovigilance Translation Services08
Market Access & Lifecycle Management
HTA and HEOR materials, payer communications, reimbursement content, medical affairs, HCP and patient education, launches, and ongoing updates.
Why Biologics Require Specialized Translation Expertise
Biopharmaceutical translation requires more than general pharmaceutical terminology. Biological products involve complex molecular structures, biological activity, specialized analytical methods, tightly controlled manufacturing processes, and interconnected scientific evidence that continues to evolve throughout the product lifecycle.
The language used to describe that evidence must remain precise wherever it appears.
Scientific Complexity
Proteins, monoclonal antibodies, recombinant products, immunological mechanisms, biological assays, biomarkers, and molecular characterization require precise scientific language and subject-matter alignment.
Product & Process Interdependence
Product characteristics and manufacturing processes are closely connected. Terminology for cell substrates, process conditions, quality attributes, analytical methods, specifications, impurities, potency, and stability must remain aligned.
Cross-Document Regulatory Continuity
The same technical concept can move from an analytical report into CMC documentation, a regulatory summary, a health authority response, product labeling, and later lifecycle updates.
Global Stakeholder Complexity
R&D, clinical, CMC, manufacturing, quality, regulatory, labeling, safety, medical affairs, market access, and local affiliate teams all depend on consistent multilingual content.
Specialized Support for Innovator Biologics and Biosimilars
Innovator biologics and biosimilars share many scientific and operational requirements, but their development and regulatory documentation are not identical. Sesen aligns multilingual workflows to the content, intended use, regulatory context, and stage of the product lifecycle.
INNOVATOR BIOLOGICS
Support From Scientific Development Through Commercial Lifecycle
- Research and nonclinical documentation
- Product and analytical characterization
- Clinical development
- CMC and manufacturing
- Biologics License Application and MAA content
- Health authority communications
- Global labeling and pharmacovigilance
- Medical affairs, market access, and lifecycle updates
BIOSIMILARS
Support for Comparative Evidence and Biosimilar Lifecycle Content
- Reference-product documentation
- Comparative analytical assessments
- Structural and functional characterization
- Quality and CMC comparability
- Clinical pharmacology and PK/PD content
- Immunogenicity and clinical evidence where required
- Scientific justification and extrapolation
- 351(k) BLA / biosimilar MAA content and lifecycle updates
BIOSIMILAR DEVELOPMENT
Multilingual Consistency Across the Biosimilar Comparability Exercise
Biosimilar development depends on a structured comparison between the proposed biosimilar and the reference product. That comparison can extend across analytical characterization, biological function, product quality, CMC information, clinical pharmacology, immunogenicity, and other supporting evidence appropriate to the development program.
When the same evidence is presented across languages, dossiers, reports, summaries, and health authority interactions, terminology needs to remain tightly controlled.
Structural & Physicochemical Characterization
Primary and higher-order structure, molecular characteristics, physicochemical properties, post-translational modifications, product variants, purity, impurities, and analytical characterization reports.
Functional & Biological Characterization
Biological activity, potency, receptor binding, functional assays, mechanism-related attributes, and comparative biological assessments.
Quality & CMC Comparability
Critical quality attributes, analytical methods, specifications, process information, control strategies, stability, product-quality comparisons, and manufacturing comparability content.
Clinical Pharmacology
Pharmacokinetics, pharmacodynamics, exposure and response, PK/PD study documentation, and comparative clinical pharmacology reports and summaries.
Immunogenicity & Clinical Evidence
Immunogenicity, safety, and clinical documentation aligned to the evidence needs of the individual development program, including comparative clinical evidence where required.
Scientific Justification & Extrapolation
Mechanism-of-action considerations, indication-specific content, extrapolation rationale, regulatory summaries, health authority questions, and sponsor responses.
One controlled multilingual evidence framework—from analytical characterization through regulatory review.
REFERENCE BIOLOGIC
COMPARATIVE EVIDENCE
STRUCTURE
FUNCTION
QUALITY / CMC
PK / PD
IMMUNOGENICITY
CLINICAL, WHERE REQUIRED
Controlled terminology · aligned references · multilingual consistency
PROPOSED BIOSIMILAR
CMC & BIOPROCESSING
Multilingual Continuity Across CMC & Biomanufacturing
Biologics manufacturing generates some of the most technically dense content in the product lifecycle. Scientific terminology, process terminology, analytical methods, specifications, quality attributes, and manufacturing controls may be repeated across regulatory submissions, manufacturing documentation, quality systems, and lifecycle changes.
Sesen provides biologics CMC translation and biopharmaceutical manufacturing translation services designed to keep this content aligned across languages and functions.
Cell Line & Upstream Processing
Cell substrates and cell banks, culture conditions, media and raw materials, fermentation and cell culture, upstream parameters, and process-development documentation.
Downstream Processing
Harvest and recovery, purification, chromatography, filtration, concentration, viral clearance or inactivation where applicable, and downstream process controls.
Drug Substance & Drug Product
Drug substance manufacture, formulation, filling and finishing, storage and handling, container-closure systems, and finished product documentation.
Analytical Methods & Specifications
Identity and potency assays, purity and impurity profiles, analytical procedures, method validation, release specifications, and stability testing and reports.
Process Validation & Comparability
Process characterization, process validation, scale-up, technology transfer, manufacturing changes, comparability assessments, and continued process verification.
GMP & Quality Systems
SOPs, master and batch records, manufacturing instructions, deviations, CAPAs, change controls, investigations, quality agreements, audits, and training.
The objective is not simply to translate each document accurately in isolation. It is to preserve the same controlled technical language across CMC submissions, manufacturing operations, quality systems, and future product changes.
Biopharmaceutical & Biosimilar Documents We Translate
Sesen supports scientific, clinical, technical, regulatory, manufacturing, quality, safety, and commercial documentation across biologics and biosimilar programs.
Scientific & Development
- Research and technical reports
- Nonclinical study content
- Pharmacology and toxicology documentation
- Product-development plans
- Scientific manuscripts and abstracts
- Investigator materials and technical assessments
Analytical & Comparability
- Analytical characterization reports
- Comparative analytical assessments
- Biosimilarity documentation
- Bioassay documentation
- Analytical procedures and method validation
- Comparability, stability, and product-quality reports
Clinical
- Clinical protocols and amendments
- Investigator Brochures
- Informed consent and patient materials
- Clinical pharmacology and PK/PD content
- Immunogenicity documentation
- Clinical study reports, summaries, and eClinical content
Regulatory & CMC
- IND and CTA supporting materials
- Biologics License Applications
- 351(k) biosimilar application content
- MAA and CTD/eCTD documentation
- Quality Overall Summaries and CMC content
- Briefing packages and health authority responses
Manufacturing & Quality
- Standard Operating Procedures
- Batch records and manufacturing instructions
- Specifications and analytical methods
- Validation protocols and reports
- Deviations, CAPAs, and change controls
- Investigations and training materials
Labeling, Safety & Commercial
- Prescribing information, SmPCs, and PILs
- Package inserts, Medication Guides, and packaging
- Safety reports and risk-management materials
- Medical affairs content
- HTA and HEOR materials
- Payer and market-access content
GLOBAL REGULATORY
Translation for Biologics & Biosimilar Regulatory Submissions
Regulatory translation for biologics requires continuity across scientific evidence, CMC documentation, clinical data, regulatory summaries, product information, and ongoing communication with health authorities. Sesen helps teams manage this content across languages without losing the approved terminology and scientific relationships established earlier in development.
U.S. Biologics & Biosimilar Submissions
- IND documentation
- 351(a) BLA content
- 351(k) biosimilar application content
- Clinical and nonclinical summaries
- CMC documentation
- Regulatory correspondence and product information
- Post-approval submissions and updates
EU & International Marketing Applications
- Marketing Authorization Applications
- CTD and eCTD Modules 1–5
- Quality documentation
- Nonclinical and clinical content
- Biosimilar comparability documentation
- Product information
- Market-specific regulatory materials
Health Authority Interactions
- Meeting packages
- Briefing documents
- Scientific advice materials
- Requests for information
- Deficiency questions and sponsor responses
- Supporting analyses
- Commitments and follow-up documentation
SUBMISSION
AUTHORITY QUESTION
SPONSOR RESPONSE
REVISED DOCUMENTATION
Multilingual Support for Global Biologics Clinical Development
Biologics clinical programs combine standard trial documentation with highly specialized product, biological, immunological, and clinical pharmacology terminology.
Sesen helps sponsors, biotechnology companies, pharmaceutical organizations, and CROs translate multinational study content while maintaining consistency with the broader scientific and regulatory program.
Clinical Trial Translation ServicesClinical Content We Support
- Protocols and amendments
- Investigator Brochures
- Informed consent and patient information
- Site and investigator documents
- Patient recruitment and engagement materials
- Clinical pharmacology and PK/PD
- Immunogenicity and safety content
- Clinical study reports
- eCOA, ePRO, and digital trial communications
Biologics-Specific Terminology Control
- Mechanism of action
- Biomarkers and biological endpoints
- Immune response and immunogenicity
- Dosage and administration
- Product-specific characteristics
- Reference-product terminology in biosimilar programs
Global Labeling for Biologics & Biosimilars
Sesen supports multilingual labeling workflows from initial product information through recurring safety, indication, manufacturing, and market-specific updates—using approved terminology, translation memory, version control, structured review, and in-context QA.
Prescribing & Regulatory Product Information
- U.S. Prescribing Information
- Summary of Product Characteristics
- Patient Information Leaflets
- Package inserts and patient information
Administration & Patient Use
- Medication Guides
- Instructions for Use where applicable
- Administration instructions
- Patient training and support materials
Packaging & Market Content
- Product labels
- Cartons
- Container content
- Packaging artwork text
- Market-specific mandatory content
Labeling Lifecycle Updates
- New indications
- Safety revisions
- Product and manufacturing-related updates
- Health authority requests
- Periodic global labeling maintenance
Multilingual Safety Support Throughout the Product Lifecycle
Biologics and biosimilars continue generating safety content during clinical development and after approval. Global pharmacovigilance teams need multilingual workflows that can handle time-sensitive reporting while preserving consistent product, medical, and safety terminology.
Case & Clinical Safety Content
- Adverse event and serious adverse event reports
- ICSRs and SUSAR-related content
- Case narratives
- Safety correspondence
- Follow-up information
Aggregate Safety & Risk Management
- DSURs
- PSURs and PBRERs
- Safety summaries
- Risk Management Plans
- Risk-minimization materials
- Benefit-risk content
Post-Market Safety Communication
- Post-marketing surveillance materials
- Signal-related content
- Safety notices
- Healthcare professional communications
- Medical information
- Safety-driven labeling updates
For biologics, terminology may also involve immunogenicity, hypersensitivity, administration-related reactions, product-specific safety concepts, and consistent identification of reference and biosimilar products.
Support Global Access From Approval Through Commercialization
Regulatory approval is not the end of a global biopharmaceutical translation program. Product information continues moving between health technology assessment bodies, payers, healthcare professionals, scientific communities, institutions, affiliates, and patients.
Market Access
- HTA documentation
- HEOR materials
- Value dossiers
- Payer communications
- Reimbursement content
- Formulary documentation
- Tender materials
Medical Affairs
- Medical information
- Advisory board materials
- Scientific presentations
- Publications
- Congress content
- HCP education
- Field medical materials
Global Launch & Patient Communication
- Launch materials
- HCP communications
- Product education
- Patient education
- Patient support content
- Training
- Market-specific communications
MULTILINGUAL CONTENT CONTROL
One Multilingual Content Framework Across Scientific, CMC & Regulatory Teams
A product name, process parameter, assay, critical quality attribute, mechanism-of-action term, manufacturing step, or scientific conclusion can appear repeatedly across analytical reports, CMC modules, clinical documentation, manufacturing procedures, health authority responses, product labeling, and safety content.
Approved Product Terminology
Maintain consistent translations for product and substance names, analytical and process terminology, quality attributes, clinical and regulatory terminology, and approved abbreviations.
Translation Memory
Identify and reuse approved translations where appropriate to support consistency across recurring and related documentation without unnecessary retranslation.
Controlled Reference Materials
Organize client-approved glossaries, prior translations, reference-product terminology, style guidance, regulatory precedents, product documentation, and client instructions.
Version Management
Maintain multilingual content through study amendments, analytical and CMC changes, manufacturing updates, submission revisions, labeling updates, safety changes, and recurring lifecycle work.
Reviewer Feedback Capture
Carry approved client and in-country reviewer decisions forward so the multilingual program becomes more consistent over time instead of restarting with every project.
The result is a multilingual content framework designed to maintain continuity as the product, evidence, documentation, and markets evolve.
CONTROLLED TECHNOLOGY
AI-Enabled Workflows With Expert Human Review
AI can improve the efficiency, consistency, and scalability of multilingual life sciences workflows, but regulated content should not be treated as a single undifferentiated use case. Sesen selects the translation and review approach according to the content, intended use, scientific complexity, regulatory context, language, scale, and required quality controls.
Content & Risk Assessment
Review content type, intended use, regulatory relevance, complexity, language requirements, volume, timeline, and required quality controls.
Terminology & Reference Alignment
Apply approved terminology, translation memory, prior translations, product references, client instructions, and other controlled linguistic resources.
SesenGPT Assistance Where Appropriate
Use controlled AI assistance for suitable content and workflows rather than applying one automated model indiscriminately to every document type.
Professional Life Sciences Linguist Review
Review scientific meaning, terminology, regulatory context, linguistic accuracy, audience appropriateness, and cross-document consistency.
AI-Assisted QA & Validation
Check terminology, omissions, numbers, units, repeated content, structural differences, and formatting consistency.
Final Human Quality Control
Keep expert human review as a core control layer for regulated and high-impact life sciences content.
Sesen's approach combines professional expertise, controlled terminology, translation memory, selective AI assistance, validation-driven QA, and accountable human review.
Quality & Security for Global Biopharmaceutical Programs
Complex multilingual programs require more than accurate translation. They need repeatable quality controls, secure workflows, qualified linguistic resources, and the ability to maintain content over time.
ISO-Certified Quality
Sesen operates within certified translation and quality systems, including ISO 17100, ISO 9001, and ISO 13485, with workflow controls selected for the engagement.
Professional Life Sciences Linguists
Projects are aligned with professional native linguists and reviewers experienced in pharmaceutical, biotechnology, medical, scientific, regulatory, manufacturing, and related content.
Terminology Governance
Glossaries, translation memory, approved references, version control, and reviewer feedback help maintain consistent language across related projects.
Human-Reviewed AI Workflows
AI assistance can support suitable workflows while qualified human review remains central to regulated and high-impact content.
Secure Global Infrastructure
Sesen supports enterprise translation workflows through secure, AWS-hosted infrastructure for sensitive life sciences content and multilingual collaboration.
150+ Languages
Support multilingual biopharmaceutical and biosimilar programs across major global markets and language groups.
Built for Complex, Multilingual Biologics Programs
Biopharmaceutical organizations need a language partner capable of understanding the connections between scientific evidence, manufacturing, regulatory documentation, product information, and lifecycle change.
Biologics Subject-Matter Expertise
Professional linguists and reviewers familiar with complex scientific, medical, biotechnology, pharmaceutical, and manufacturing content.
Biosimilar Comparability Support
Multilingual continuity across reference-product comparisons, analytical characterization, CMC, clinical pharmacology, immunogenicity, and supporting regulatory evidence.
CMC & Manufacturing Continuity
Consistent technical language across regulatory CMC content, manufacturing processes, analytical methods, quality documentation, and product changes.
Regulatory Lifecycle Support
Translation support from development and submission through health authority communication, labeling, safety, and post-approval maintenance.
Scalable Global Workflows
Structured delivery for individual documents, multilingual submissions, recurring manufacturing content, multi-market launches, and long-term lifecycle updates.
Technology + Human Expertise
Terminology governance, translation memory, SesenGPT assistance where appropriate, AI-supported QA, and professional human review within one controlled workflow.
Biopharmaceutical & Biosimilar Translation FAQs
Answers to common questions about multilingual biologics, biosimilar comparability, CMC, regulatory, labeling, and lifecycle translation support.
Biopharmaceutical translation services support the multilingual scientific, clinical, technical, regulatory, manufacturing, labeling, safety, and commercial content associated with biological medicines. Sesen supports biologics programs across research and product development, analytical characterization, clinical studies, CMC and manufacturing, regulatory submissions, product labeling, pharmacovigilance, medical affairs, market access, and post-approval lifecycle management.
Yes. Sesen supports multilingual biosimilar programs from comparative analytical characterization and CMC documentation through clinical pharmacology, immunogenicity, clinical evidence where required, regulatory submissions, labeling, and lifecycle updates. Our role is to translate and manage multilingual content accurately and consistently within the sponsor's scientific and regulatory strategy.
Sesen supports translation for a broad range of biopharmaceutical and biotechnology content, including documentation involving therapeutic proteins, monoclonal antibodies, recombinant products, immunological products, biosimilars, and other complex biological medicines. The linguistic team and workflow are selected according to the specific scientific subject matter and content requirements of each program.
Yes. Sesen supports documentation related to comparative analytical characterization, structural and functional properties, product quality, CMC comparability, PK/PD, immunogenicity, clinical evidence where applicable, scientific justification, and related regulatory communication. Controlled terminology and references can be maintained across related evidence streams to support multilingual consistency throughout the program.
Yes. Sesen translates CMC, manufacturing, analytical, validation, and quality documentation for biopharmaceutical programs, including process-development documentation, analytical methods, specifications, stability reports, SOPs, manufacturing instructions, batch records, validation content, deviations, CAPAs, change controls, quality documentation, and technology-transfer materials.
Yes. Sesen supports multilingual content associated with biologics and biosimilar regulatory submissions, including Biologics License Applications, 351(k) biosimilar application content, Marketing Authorization Applications, CTD/eCTD documentation, CMC materials, regulatory summaries, briefing packages, health authority correspondence, and post-approval updates.
Yes. Sesen supports multilingual labeling and product information for biologics and biosimilars, including prescribing information, SmPCs, patient information leaflets, package inserts, Medication Guides, administration content, packaging, market-specific product information, and ongoing labeling updates.
Sesen can maintain client-approved terminology, translation memory, product references, prior translations, style guidance, regulatory precedents, and reviewer decisions across related projects. These linguistic assets help keep scientific, CMC, clinical, regulatory, manufacturing, labeling, and safety terminology aligned as documentation evolves.
Sesen uses AI-enabled translation and quality technologies within controlled workflows when appropriate to the content and intended use. SesenGPT can work alongside translation memory, terminology governance, automated quality validation, and professional life sciences linguist review. Regulated and high-impact content remains subject to human oversight appropriate to the project.
Yes. Sesen supports recurring multilingual content throughout the product lifecycle, including clinical amendments, manufacturing changes, submission updates, health authority responses, labeling revisions, safety updates, medical affairs content, and market-specific product communication. Maintained terminology and translation memory can help preserve continuity between the initial project and future updates.
Yes. Sesen can support focused translation needs for emerging biotechnology and biosimilar developers as well as larger multilingual programs involving multiple departments, content streams, languages, markets, and recurring lifecycle updates.
Sesen supports biopharmaceutical and biosimilar translation in 150+ languages, enabling scientific, clinical, regulatory, manufacturing, labeling, safety, and commercial communication across global markets.
Support Your Global Biologics Program With Specialized Translation Expertise
From analytical characterization and biosimilar comparability to CMC, clinical development, global submissions, manufacturing, labeling, pharmacovigilance, and commercialization, Sesen helps biopharmaceutical teams maintain accurate and consistent multilingual content throughout the product lifecycle.