Sign In
Life Sciences Translation Assurance

Quality, Compliance & Security for Regulated Life Sciences Translation

Sesen helps pharmaceutical, biotechnology, medical device, CRO, and healthcare organizations translate regulated content with ISO-certified quality processes, secure workflows, terminology controls, and audit-ready documentation.

TALK WITH TEAM SESEN VIEW OUR QUALITY PROCESS
ISO 17100
ISO 9001:2015
ISO 13485:2016
150+ Languages

ISO-Certified Quality

Translation, review, and delivery workflows aligned with ISO 17100, ISO 9001:2015, and ISO 13485:2016.

Regulated Content Controls

Processes built for clinical, regulatory, labeling, IFU, patient-facing, and medical software content.

Security & Confidentiality

Controlled access and secure handling for sensitive life sciences documents, references, and project materials.

Audit-Ready Workflows

Documented QA steps, reviewer accountability, version control, and delivery records for regulated programs.

Regulated Life Sciences Content

Built for the Quality Expectations of Life Sciences Organizations

Sesen’s quality framework is designed for regulated multilingual content where accuracy, consistency, confidentiality, and documented review are essential.

Life sciences translation requires more than linguistic accuracy. Clinical trial documents, regulatory submissions, drug labeling, medical device IFUs, patient communications, safety information, and medical software content must be translated with subject matter expertise, terminology consistency, formatting accuracy, confidentiality, and documented review.

Sesen is built specifically for regulated life sciences translation workflows. We support pharmaceutical, biotechnology, medical device, CRO, and healthcare organizations with professional native medical linguists, structured quality processes, terminology management, translation memory, AI-assisted QA, and secure project controls.

Our approach helps clients manage multilingual content with greater consistency, traceability, and confidence across markets. From clinical trial translation QA and regulatory translation compliance to labeling translation quality control and audit-ready delivery, Sesen provides the language quality framework required for sensitive, regulated content.

Quality Focus Areas

Core controls that help regulated organizations evaluate translation quality, compliance readiness, and secure delivery.

Translation Quality

Life sciences translation quality, medical translation quality assurance, and clinical trial translation QA.

Compliance Readiness

Regulated translation workflows, regulatory translation compliance, and audit-ready translation processes.

Secure Delivery

Labeling translation quality control and secure translation services for sensitive content.

Certified Quality Framework

ISO-Certified Quality Processes

Sesen’s ISO-certified processes give life sciences organizations a structured foundation for managing translation quality, regulatory expectations, confidentiality, and audit-ready documentation across global content programs.

ISO 17100

Translation Services Quality Standard

Sesen follows translation service workflows aligned with ISO 17100, including qualified linguist selection, translation by professional native subject matter linguists, independent review, project management oversight, and quality control before delivery.

Relevant For

Clinical trial materials, regulatory documents, patient-facing content, labeling, and medical communications.

ISO 9001:2015

Quality Management System

Sesen applies ISO 9001:2015 quality management principles across project intake, resource assignment, workflow control, issue tracking, client communication, corrective actions, and continuous improvement.

Relevant For

Ongoing multilingual programs, recurring translation workflows, terminology management, and enterprise client requirements.

ISO 13485:2016

Medical Device Quality Management

Sesen supports translation workflows for medical device documentation under quality practices relevant to ISO 13485:2016, including IFUs, labeling, software, safety information, packaging content, and user documentation.

Relevant For

Medical device IFUs, labeling, packaging, software localization, safety content, and regulated product documentation.

Translation Quality Assurance

Translation Quality Assurance From Intake to Delivery

Sesen follows a structured translation quality assurance workflow for regulated life sciences content, combining professional native medical linguists, terminology management, translation memory, AI-assisted QA, and final human review.

Designed for regulated content

Clinical trial documents, regulatory submissions, drug labeling, medical device IFUs, patient communications, safety information, and medical software content.

Audit-ready delivery

The workflow supports regulated translation process requirements, medical translation quality assurance, terminology validation, AI-assisted translation QA, human-reviewed translation, and documentation for audit-ready translation workflows.

Discuss your QA requirements
Regulated Content Controls

Quality Controls for Regulated Life Sciences Content

Regulated life sciences content requires quality controls that reflect the purpose, audience, risk level, and regulatory context of each document type.

Sesen applies content-specific quality controls across clinical, regulatory, labeling, packaging, medical device, healthcare, and digital health translation workflows.

Matched to content type and risk

Quality review priorities are adapted to the content audience, market, regulatory use, formatting requirements, and client-approved references.

Terminology Governance

Terminology and Translation Memory Controls

Terminology consistency is critical for regulated life sciences translation. Product names, clinical terms, study references, dosage language, device components, safety statements, labeling phrases, regulatory terminology, and patient-facing instructions must remain consistent across documents, languages, markets, and lifecycle updates.

Sesen helps clients maintain consistency across recurring translation programs through approved terminology, translation memory, style guides, product references, and client-specific linguistic rules.

Consistency across global content programs

Terminology controls help reduce review cycles, support audit readiness, and maintain approved language across clinical, regulatory, labeling, and medical device content.

01

Terminology Governance

Approved glossary use, client-specific terminology rules, product and brand terminology, and medical terminology consistency help keep high-impact language aligned across clinical, regulatory, labeling, medical device, and patient-facing content.

Control Areas

  • Approved glossary use
  • Client-specific terminology rules
  • Product and brand terminology
  • Medical terminology consistency
02

Translation Memory Control

Translation memory helps reuse previously approved translations across recurring projects, related documents, updated versions, software strings, labeling revisions, IFU updates, and modular submission content.

Control Areas

  • Previously approved translations
  • Recurring content reuse
  • Lifecycle updates
  • Software and labeling revisions
03

Style & Market Alignment

Style guides, formatting rules, abbreviation preferences, patient-facing language requirements, and country-specific terminology help translated content reflect client expectations and local market use.

Control Areas

  • Style guide alignment
  • Country and market preferences
  • Patient-facing language rules
  • Formatting and abbreviation rules
04

Change Management

Version-aware workflows help manage recurring updates for labeling, IFUs, clinical trial amendments, regulatory changes, safety updates, and multilingual product communications.

Control Areas

  • Version-aware review
  • Labeling and IFU revisions
  • Clinical trial amendments
  • Modular submission content reuse

Related Governance Resources

Explore how Sesen manages terminology, AI-assisted terminology intelligence, and content reuse for regulated multilingual programs.

Glossaries & Style Guides Learn more AI Terminology Intelligence Learn more Modular Submission & Content Reuse Learn more
ai-assisted-Assisted Quality Review

ai-assisted-Assisted QA With Human Oversight

Sesen uses ai-assisted-assisted quality checks to support human reviewers, not replace them. These checks help identify potential issues across long, technical, or frequently updated life sciences documents.

For regulated life sciences content, final quality decisions remain under human review by qualified linguists, project managers, and client-approved review teams.

Human review remains the final quality gate

AI helps reviewers focus on areas that require attention. Qualified linguists and project teams review flagged issues in context before final delivery.

Validation Checklist

What ai-assisted-assisted QA helps check

01

Terminology Consistency

Helps flag inconsistent use of approved medical, clinical, regulatory, product, and labeling terminology.

02

Numeric and Unit Accuracy

Helps identify discrepancies in numbers, percentages, dosages, units of measure, dates, visit schedules, tables, and structured content.

03

Completeness and Missing Content

Helps surface missing translations, omitted segments, untranslated text, duplicated content, and source-to-target inconsistencies.

04

Formatting and Structural Integrity

Helps identify formatting irregularities, table issues, layout inconsistencies, tag problems, numbering errors, and document structure differences.

05

Repeated Segment Consistency

Helps compare repeated or similar segments across documents to support consistency in safety statements, instructions, warnings, and labeling phrases.

06

Version and Change Review

Helps compare revised content against previous versions for labeling updates, IFU revisions, regulatory changes, clinical amendments, and product communications.

Related AI and QA Resources

Explore related Sesen resources on ai-assisted-assisted validation, hybrid translation, labeling workflows, and in-context QA.

AI Validation & QA for Life Sciences https://www.sesen.com/ai-assisted-validation-qa-life-sciences/ SesenGPT Hybrid Translation https://www.sesen.com/sesengpt-hybrid-translation/ Life Sciences Labeling Workspace https://www.sesen.com/life-sciences-labeling-workspace/ Label Review & In-Context QA https://www.sesen.com/label-review-in-context-qa/
Data Security & Confidentiality

Secure Handling of Sensitive Life Sciences Content

Sesen supports secure translation workflows for sensitive life sciences content, including clinical trial documents, regulatory submissions, product labeling, medical device documentation, patient communications, safety information, software content, and internal company materials.

Life sciences translation often involves confidential product information, clinical study details, unpublished regulatory materials, proprietary terminology, and internal reference documents. Sesen applies controlled project workflows to help clients manage these materials with confidentiality, access control, and careful handling.

Security controls matched to project requirements

Specific data handling, storage, transfer, and confidentiality requirements can be reviewed during vendor onboarding, MSA review, or project setup.

Security Control Areas

Practical safeguards for sensitive content

01

Access Control

Controlled file access and restricted access based on project role help limit sensitive materials to assigned team members who need them for translation, review, QA, formatting, or delivery.

Included Controls

Controlled file access
Restricted access based on project role
02

Confidentiality

Project managers, linguists, reviewers, and other project personnel work under confidentiality obligations appropriate to the assignment. Sesen can also support NDA and MSA requirements.

Included Controls

Confidentiality obligations
Support for NDA and MSA requirements
03

Secure Workflow

Structured project management workflows support file intake, resource assignment, translation, review, QA, delivery, and client communication. Where applicable, Sesen’s systems are hosted on AWS.

Included Controls

Secure project management workflows
Secure storage and transfer practices
AWS-hosted systems where applicable
04

Client-Specific Handling

Sesen can follow client-specific instructions for sensitive content, including reference material handling, approved communication channels, naming conventions, access limitations, and delivery requirements.

Included Controls

Careful handling of client reference materials
Client-specific instructions for sensitive content

Sensitive Content We Help Protect

Sesen’s secure translation workflows are designed for confidential life sciences materials and regulated documentation.

Clinical trial documents
Regulatory submissions
Product labeling
Medical device documentation
Patient communications
Safety information
Software content
Internal company materials

Security Note

Sesen’s security approach is designed to support sensitive life sciences translation workflows. Specific security, data handling, storage, transfer, and confidentiality requirements can be reviewed with clients during vendor onboarding, MSA review, or project setup.

Discuss your security requirements
Workflow Documentation

Audit-Ready Translation Workflows

For regulated content, clients often need more than final translated files. They may need documentation showing how the work was completed, who reviewed the content, what quality steps were performed, which reference materials were used, and how final delivery was controlled.

Sesen can support audit-ready translation programs with structured project records and documentation aligned with client requirements.

Documentation aligned with enterprise review

Project documentation can be aligned with client onboarding, procurement, QA, regulatory, legal, or recurring program governance requirements.

Audit Documentation Framework

Structured records for regulated translation programs

01

Scope & Resources

Project intake records, language and file scope, and assigned linguist and reviewer roles help define what was translated, who supported the work, and how the project was structured.

Documentation Items

Project intake records
Language and file scope
Assigned linguist and reviewer roles
02

References & QA

Reference material tracking, glossary and style guide use, QA check records, and issue resolution notes help show which quality controls were applied during translation and review.

Documentation Items

Reference material tracking
Glossary and style guide use
QA check records
Issue resolution notes
03

Delivery & Lifecycle

Delivery records, translation certificates when required, and version and revision history for recurring updates help support traceability after final delivery.

Documentation Items

Delivery records
Translation certificates when required
Version and revision history for recurring updates

Documentation That Supports Enterprise Review

Sesen’s audit-ready translation workflows help regulated organizations maintain traceability across multilingual content programs.

Procurement reviews
Regulatory documentation
QA requirements
Legal review
Vendor onboarding
Recurring multilingual content governance

Program Governance Note

Sesen can align translation documentation with client requirements during onboarding, MSA review, project setup, recurring program governance, or regulated content lifecycle planning.

Discuss audit-ready workflow requirements
Content-Specific QA

Quality Checks Matched to Each Content Type

Sesen applies content-specific quality checks based on the purpose, audience, risk level, and regulatory context of each document. This helps clinical, regulatory, labeling, medical device, patient-facing, software, and commercial content receive the right level of linguistic, technical, and formatting review.

Quality review matched to purpose

Each content type is reviewed against the terminology, formatting, compliance, readability, and user-context requirements most relevant to its intended use.

Content Type
Quality Focus
Related Page
01

Clinical Trial Documents

Medical accuracy, patient comprehension, study terminology, protocol consistency, IRB and ethics references.

Examples

ICFs, protocols, patient questionnaires, recruitment materials, study communications.

02

Regulatory Documents

Terminology precision, structural consistency, submission context, country-specific language expectations.

Examples

Regulatory submissions, agency correspondence, dossiers, safety documentation.

03

Drug Labeling & Packaging

Version control, safety language, dosage information, warnings, terminology consistency, layout accuracy.

Examples

Prescribing information, patient labeling, package inserts, cartons, labels, safety updates.

04

Medical Device IFUs

Instruction clarity, warning language, diagrams and callouts, formatting, revision consistency.

Examples

Instructions for Use, user manuals, quick reference guides, device labeling, safety notices.

05

Patient-Facing Materials

Plain language, cultural appropriateness, readability, medical accuracy, sensitivity.

Examples

Patient education materials, consent forms, appointment instructions, disease awareness content.

06

Medical Software & UI Content

String consistency, UI context, character limits, in-context review, functional clarity.

Examples

EHR interfaces, eCOA platforms, medical device software, patient portals, telemedicine apps.

07

Marketing & Commercial Content

Brand voice, medical claims consistency, market appropriateness, terminology alignment.

Examples

Product brochures, launch materials, websites, sales training, HCP communications.

Sesen Quality Difference

Why Life Sciences Organizations Choose Sesen

Sesen is built for life sciences organizations that need more than basic translation. We support regulated multilingual content programs with professional native medical linguists, ISO-certified quality processes, terminology controls, secure workflows, AI-assisted QA, and human review.

Our work is focused on the content areas where quality, consistency, confidentiality, and traceability matter most, including clinical trial documents, regulatory submissions, drug labeling, medical device IFUs, patient-facing materials, healthcare communications, and medical software localization.

Built for regulated multilingual content

Sesen combines language expertise, quality governance, secure workflows, AI-assisted QA, and flexible delivery models for life sciences organizations.

Talk with Team Sesen

Proof Points

What sets Sesen apart

01

Life Sciences Specialization

Exclusive focus on pharmaceutical, biotechnology, medical device, CRO, and healthcare translation.

02

Professional Native Medical Linguists

Qualified linguists selected for language, subject matter experience, document type, and target market.

03

ISO-Certified Quality Processes

Structured quality workflows supported by ISO 17100, ISO 9001:2015, and ISO 13485:2016.

04

150+ Languages

Global language support for clinical, regulatory, labeling, medical device, healthcare, and software content.

05

Terminology and Translation Memory Controls

Approved terminology, translation memory, style guides, product references, and client-specific linguistic rules.

06

AI-Assisted QA Under Human Review

Technology-enabled QA checks that support human reviewers while final quality decisions remain under human control.

07

Secure Handling of Sensitive Content

Controlled workflows for confidential clinical, regulatory, labeling, medical device, patient-facing, and internal materials.

08

Flexible Workflow Models

Support for human translation, hybrid translation, MTPE, linguistic review, AI-assisted QA, and recurring content updates.

A Complete Quality Framework

Sesen brings together the capabilities regulated organizations need to manage multilingual content with confidence.

Together, these capabilities help Sesen support regulated multilingual content with the quality, consistency, confidentiality, and traceability required by life sciences organizations.

Related Resources

Related Quality, Compliance & Security Resources

Explore related Sesen services, solutions, and resources that support regulated life sciences translation quality, compliance readiness, terminology consistency, AI-assisted QA, labeling control, and secure multilingual content workflows.

Built for internal linking and topical authority

These links connect quality, compliance, security, AI validation, terminology governance, and regulated content workflows across the Sesen website.

Clinical, Regulatory & Labeling Translation

Core regulated translation services for clinical trials, submissions, labeling, packaging, and medical device instructions.

Clinical Trial Translation Services https://www.sesen.com/clinical-trial-translation-services/ Regulatory & Compliance Translation https://www.sesen.com/regulatory-compliance-translation-services/ Drug Labeling & Packaging Translation https://www.sesen.com/drug-labeling-packaging-translation/ IFU Translation Services https://www.sesen.com/ifu-translation-services/

Software, Digital Health & Medical Technology

Localization support for clinical software, digital health systems, regulated UI content, and multilingual user experiences.

Clinical & Medical Software Localization https://www.sesen.com/clinical-medical-software-localization/

AI-Assisted QA & Hybrid Translation

Human-reviewed AI workflows, validation checks, labeling controls, and hybrid translation for regulated life sciences content.

AI Validation & QA for Life Sciences https://www.sesen.com/ai-validation-qa-life-sciences/ SesenGPT Hybrid Translation https://www.sesen.com/sesengpt-hybrid-translation/ Life Sciences Labeling Workspace https://www.sesen.com/life-sciences-labeling-workspace/

Terminology, Governance & Content Reuse

Resources for terminology control, style guide governance, translation memory, modular content reuse, and recurring updates.

Glossaries & Style Guides https://www.sesen.com/resources/glossaries-style-guides/ Modular Submission & Content Reuse https://www.sesen.com/modular-submission-translation-content-reuse/
Talk With Team Sesen

Discuss Your Quality, Compliance, and Security Requirements

Talk with Team Sesen about your clinical, regulatory, labeling, medical device, healthcare, or software localization workflows. We can help you design a translation process that supports quality, consistency, confidentiality, and audit readiness across global markets.

TALK WITH TEAM SESEN REQUEST A QUOTE