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Documents We Translate

We translate a wide range of clinical, medical device, pharmacovigilance and regulatory documents, ensuring linguistic accuracy, regulatory alignment and secure handling across all stages of the healthcare and research lifecycle.

Documents Requiring Translation in Clinical Research

These must be translated into the participant’s understandable local language.
  • Informed Consent Form (ICF)
  • Assent Form (for minors or legally incapable participants)
  • Participant Information Sheet (PIS)
  • Patient Diaries (paper or e-diary content)
  • Questionnaires / PROs / COAs
  • Recruitment Materials
    • Advertisements
    • Posters, flyers
    • Social media recruitment text
  • Patient Instructions
    • Dosing instructions
    • Device usage guides
  • Visit Schedules / Study Calendars
  • Re-consent Forms (protocol amendments)
  • Patient Cards
    • Emergency cards
    • Pregnancy prevention cards
  • Patient Education Materials
  • Compensation & Reimbursement Information
  • Data Privacy / GDPR Notices (patient version)
Regulatory Note:EC/IRB approval is typically required after translation.

Required when interacting with patients, sites or local authorities.

  • Patient Safety Information
  • Adverse Event (AE) Reporting Forms (patient-facing)
  • Pregnancy Reporting Forms
  • Safety Letters to Investigators or Patients
  • Risk Minimization Materials (RMP tools)

Translated when sites or staff are non-English speaking.

  • Protocol Synopsis
  • Investigator’s Brochure (IB) – selected sections or full
  • Study Manuals / Site Manuals
  • Training Materials
  • Delegation Logs (instructions)
  • Laboratory Manuals
  • Device Instructions (IFU)

Required for local authority or ethics committee review.

  • Clinical Trial Application (CTA) Summaries
  • Cover Letters to EC/Regulatory Authority
  • Regulatory Declarations
  • Patient-facing annexures
  • Local language labelling text
  • Approved Translated ICFs (final stamped copies)

Translated where local language documentation is mandated.

  • Clinical Trial Agreements (CTAs) – partial or full
  • Confidentiality Agreements
  • Insurance Certificates (patient coverage sections)
  • Indemnity Statements
  • Subject Compensation Policies

Typically translated for local audits or inspections.

  • Standard Operating Procedures (SOPs) (site-specific)
  • Work Instructions
  • Quality Checklists
  • Audit Responses (local language requests)

Often required for participant communication and archiving.

  • Study Results Summaries (lay language)
  • Thank-You Letters to Participants
  • End-of-Study Notifications
  • Long-term Follow-up Instructions
  • ICF / Assent Forms
  • PRO / COA instruments
  • Patient diaries
  • Questionnaires

Usually require:

  • Forward translation
  • Review
  • Back translation (if required)
  • Reconciliation
  • QA & certification

Key Compliance Translation Expectations

  • Translation must be accurate, culturally appropriate and understandable
  • Machine translation alone is not acceptable
  • Qualified human translators (medical/clinical background) expected
  • Version control & audit trail must be maintained
  • Aligns with ICH-GCP E6 (R2/R3), ISO 17100 and local EC guidelines

Documents Requiring Translation in Medical Devices

These documents must be translated into the official language(s) of the country where the device is marketed or used.
  • Instructions for Use (IFU)
  • User Manuals / Operator Manuals
  • Quick Reference Guides
  • Patient Information Leaflets
  • Implant Cards
  • Patient ID / Device Cards
  • Home-use Instructions
  • Maintenance Instructions (user-relevant)
  • Safety Warnings & Precautions
  • Labeling Content (textual)
  • Symbols Explanations (if text is used)
EU MDR requirement:IFU and labelling must be in local official language(s).

Essential for regulatory approval and market access.

  • Device Labels
  • Packaging Text
  • Outer Carton Information
  • UDI-related Text
  • Sterilization & Storage Instructions
  • Expiry / Shelf-Life Statements
  • Traceability Statements

Required when devices are tested or investigated in non-English-speaking regions.

  • Clinical Investigation Plan (CIP) – patient sections
  • Informed Consent Forms (ICF)
  • Participant Information Sheets
  • Case Report Forms (patient-facing sections)
  • Patient Diaries / Questionnaires
  • Clinical Evaluation Reports (CER) – summaries if required
  • Post-Market Clinical Follow-up (PMCF) Questionnaires

Translated to meet local authority or notified body expectations.

  • Declarations of Conformity (DoC)
  • Regulatory Application Summaries
  • Cover Letters to Authorities
  • Regulatory Correspondence
  • National Registration Documents
  • Local Market Authorization Certificates

Critical for patient safety and compliance.

  • Vigilance / Adverse Event Reporting Forms
  • Incident & Complaint Forms
  • Field Safety Corrective Action (FSCA) Documents
  • Field Safety Notices (FSN)
  • Recall Communications
  • Periodic Safety Update Reports (PSUR – summaries if required)
  • Trend Reports (local language, if requested)

Required when documents are shared with users or regulators.

  • Risk Management File – summaries
  • Hazard & Risk Communication Materials
  • Benefit-Risk Information (patient-relevant)
  • Usability / Human Factors Study Summaries
  • Warnings & Contraindications

Translated for local users, distributors, or service personnel.

  • Training Manuals
  • Installation Guides
  • Service & Maintenance Manuals
  • Troubleshooting Guides
  • Distributor Training Materials
  • e-Learning Content

Required for local audits or inspections.

  • SOPs (local language versions)
  • Work Instructions
  • Quality Manuals
  • CAPA Documents (local)
  • Audit Responses
  • Inspection Readiness Files

Translated when legally required.

  • Warranty Statements
  • Distributor Agreements (relevant sections)
  • Service Level Agreements (SLA)
  • Customer Contracts (device use clauses)
  • Insurance Certificates (device coverage)

Documents Requiring Translation in Pharmacovigilance (PV)

These documents must be translated into the local language to ensure patient safety and correct reporting.

  • Adverse Event (AE) / Adverse Drug Reaction (ADR) Reporting Forms
  • Patient Safety Information Leaflets
  • Medication Guides / Patient Information Leaflets (PIL)
  • Risk Minimization Materials
    • Patient alert cards
    • Pregnancy prevention materials
    • Educational brochures
  • Informed Consent Language Related to Safety (PV-specific sections)
  • Follow-up Questionnaires for Patients
  • Consumer Complaint Forms
  • Lay Language Safety Summaries
Required when source information is received in a non-English language.
  • Source Case Narratives
  • Patient / HCP Written Statements
  • Medical Records Used for Case Assessment
    • Discharge summaries
    • Lab reports
    • Physician notes
  • Autopsy Reports / Death Certificates
  • Translated Case Narratives for Global Databases
    • E2B (R3) submissions
  • Causality Assessment Justifications
Regulatory expectation: Accurate translation is essential to avoid misclassification or under-reporting.

Translated to comply with local authority requirements.

  • Dear Healthcare Professional (DHCP) / Dear Doctor Letters
  • Urgent Safety Communications
  • Field Safety Notices
  • Recall Notifications
  • Regulatory Authority Correspondence
  • Local Health Authority Queries & Responses

Required when reports are submitted or reviewed by local regulators.

  • PSUR / PBRER (patient-relevant sections if required)
  • DSUR (local submission components)
  • ASR (Annual Safety Reports)
  • Signal Evaluation Summaries (local language, if requested)

Translated when used locally or reviewed by regulators.

  • Risk Management Plans (RMP) – patient & HCP sections
  • Signal Detection Reports
  • Benefit-Risk Evaluation Summaries
  • Safety Concern Lists
  • Additional Risk Minimization Measure (aRMM) Materials

Translated for local affiliates, partners, or inspections.

  • PV SOPs (local versions)
  • Work Instructions (WI)
  • Safety Processing Manuals
  • Training Materials (PV-specific)
  • Business Continuity & Escalation Procedures

Critical for global safety data exchange.

  • Safety Data Exchange Agreements (SDEA) – relevant sections
  • PV Agreements
  • Partner Safety Notifications
  • Third-Party Case Exchange Documentation

Required during local inspections.

  • Audit Responses
  • Corrective and Preventive Action (CAPA) Documents
  • Inspection Readiness Documentation
  • Deviation Reports Related to Safety
  • Root Cause Analysis (RCA)

Machine translation alone is NOT acceptable for these documents.

Documents Requiring Translation in a Regulatory Services Organization

Required for market authorization, clinical trial approval and variations.

  • CTD / eCTD Modules (selected or full)
    • Module 1 (Regional administrative &labeling documents)
    • Module 2 summaries (as required locally)
  • Clinical Trial Applications (CTA)
  • Investigational New Drug (IND) / NDA / BLA
  • Marketing Authorization Applications (MAA)
  • Medical Device Registration Dossiers
  • IVD Registration Files
  • Combination Product Submissions
  • Renewals, Variations & Amendments
  • Fast-track / Priority Review Requests

Mandatory for country-specific approvals.

  • SmPC / Prescribing Information
  • Package Leaflet (PL) / Patient Information Leaflet (PIL)
  • Medication Guides
  • Instructions for Use (IFU)
  • Container & Carton Labels
  • Artwork Text Content
  • QRD-compliant texts
  • UDI labeling text (devices)

Used for authority interactions and lifecycle management.

  • Cover Letters to Health Authorities
  • Authority Questions / Deficiency Letters
  • Responses to Queries (LoQ / IR / RFI)
  • Scientific Advice Requests & Responses
  • Meeting Briefing Documents
  • Post-approval Commitments

Required for clinical development and ongoing safety compliance.

  • Investigator’s Brochure (IB)
  • Clinical Study Protocols (selected sections)
  • Informed Consent Forms (ICF)
  • Patient Information Sheets
  • DSUR / PSUR / PBRER (local submission sections)
  • Risk Management Plans (RMP)
  • Pharmacovigilance System Master File (PSMF) – summaries
  • Safety Communications to Authorities

Translated for local authority review or inspections.

  • Quality Overall Summary (QOS)
  • CMC Documentation (selected sections)
  • Manufacturing Site Information
  • Process Descriptions
  • Validation Summaries
  • Stability Study Summaries
  • GMP Certificates & Declarations

Critical during regulatory inspections.

  • Inspection Readiness Documents
  • Audit Reports (local use)
  • CAPA Documentation
  • Deviation Reports
  • Root Cause Analysis (RCA)
  • Regulatory Inspection Responses

Used throughout the product lifecycle.

  • Change Control Submissions
  • Safety Variations
  • Labeling Updates
  • Post-Marketing Commitments
  • Renewal & Sunset Clause Documents
  • Withdrawal / Suspension Communications

Required when local language documentation is mandated.

  • Letters of Authorization (LoA)
  • Power of Attorney (PoA)
  • Regulatory Agreements
  • Confidentiality Agreements
  • Distributor / Agent Authorization Letters
  • Notarized &Apostilled Document
Our Services

Language Translation Services

We deliver accurate, context-aware language translation services designed for clinical research and regulated industries. Our linguists ensure clarity, compliance and consistency across study documents, regulatory submissions and global communications.

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