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Clinical Trial Document Translation Services
- ISO 17100
- ATA
- USCIS Accepted
- NAJIT
A multi-site international clinical trial depends on translation at every stage — protocols, informed consent forms, case report forms, adverse event reports. Each must be translated with precision to protect patient safety and maintain regulatory compliance.
Translation AZ provides certified clinical trial translation for CROs, pharmaceutical companies, biotech firms, and academic research institutions. Our translators are trained in ICH-GCP requirements.
Documents We Translate
Clinical trial protocols
Objectives, design, methodology, and statistical considerations
Informed consent forms (ICFs)
Ensuring participants understand the trial, with HIPAA authorization language
Investigator brochures
Comprehensive summaries of clinical and non-clinical data
Case report forms (CRFs/eCRFs)
Data collection instruments requiring identical structure across languages
Patient-reported outcome measures (PROMs)
Validated questionnaires requiring linguistic validation
Clinical study reports (CSRs)
Methodology, results, and statistical analysis
Adverse event reports
Time-sensitive SAE reports and PSURs
IRB/ethics committee submissions
Applications and correspondence with Institutional Review Boards
IND supporting documents
Source documents supporting FDA IND applications
Linguistic Validation and Back-Translation
For PROMs and COAs, simple translation is insufficient. We support the full linguistic validation workflow: forward translation, reconciliation, back-translation, clinician review, cognitive debriefing, and harmonization across all language versions.
ICH-GCP Compliance
ICH-GCP requires all participant information in a language they understand. We ensure compliance with ICH-GCP and 21 CFR Part 50, including accurate risk/benefit representation, consistent terminology, and version-controlled audit trails.
How It Works
Submit trial documents
Include therapeutic area, target languages, and trial phase.
Quote within 2 hours
We assess volume, complexity, and linguistic validation needs.
Translation and review
Specialist medical linguist. PROMs undergo full linguistic validation.
Certified delivery
Version-controlled and formatted for regulatory submission.
2-Hour Quote Response Standard 24–72 hrs · Rush available
Running an International Clinical Trial?
Submit your trial documents for a free quote.
Frequently Asked Questions
Yes. Independent back-translation as part of linguistic validation for PROMs, COAs, and ICFs.
Yes. Phase I through Phase IV, including pre-clinical and post-market surveillance.
Expedited turnaround for SAE reports. We confirm feasibility within 1 hour.
Yes. Oncology, cardiology, neurology, immunology, rare diseases, and gene/cell therapy.
FDA Regulatory Submission Translation Services
- ISO 17100
- ATA
- USCIS Accepted
- NAJIT
Every drug, biologic, and device seeking US market approval must pass FDA review. For internationally developed products, this means translating clinical data, manufacturing documentation, and labeling into English with FDA-grade precision.
Translation AZ provides certified translation for pharmaceutical companies, biotech firms, device manufacturers, and regulatory consultants. Our translators know FDA submission formats, eCTD structure, and CDER/CBER/CDRH terminology.
Documents We Translate
IND applications
Pre-clinical data, protocols, investigator brochures, and CMC information
NDA submissions
Clinical study reports, statistical analyses, labeling, and manufacturing data
ANDA submissions
Bioequivalence data and labeling for generic drug approval
510(k) premarket notifications
Substantial equivalence analyses, device descriptions, performance data
PMA applications
Clinical data and manufacturing documentation for Class III devices
BLA submissions
Biological product approval applications
FDA labeling and USPI
Prescribing information, medication guides, patient package inserts
CMC sections
Drug substance/product specifications, stability data, manufacturing processes
FDA correspondence
Complete response letters, information requests, meeting documents
Post-market safety reports
MedWatch, PADERs, and REMS documentation
FDA Division Expertise
We support submissions to CDER (drugs), CBER (biologics, vaccines, gene therapy), and CDRH (medical devices).
eCTD Format
Our translators are familiar with eCTD module structure (Modules 1–5) and ensure translations align with correct sections for your regulatory publishing workflow.
How It Works
Submit regulatory documents
Include submission type, FDA division, and deadline.
Quote within 2 hours
Specialist regulatory linguists assigned.
Translation and review
FDA terminology specialist with independent review.
Certified delivery
Formatted for eCTD integration.
2-Hour Quote Response Standard 24–72 hrs · Rush available
Preparing an FDA Submission?
Submit your regulatory documents for a free quote.
Frequently Asked Questions
Yes. CSRs, protocols, and source data from international trials for IND and NDA submissions.
Yes. 21 CFR Part 201, Highlights formatting, and medication guide requirements.
Yes. Complete premarket notifications including device descriptions and performance data.
Yes. Translations aligned with eCTD modules, working with your publishing team.
Pharmaceutical Labeling & Packaging Translation Services
- ISO 17100
- ATA
- USCIS Accepted
- NAJIT
A mistranslated dosage instruction can cause harm. An omitted contraindication can put lives at risk. Pharmaceutical labeling translation is a matter of patient safety.
Translation AZ provides certified translation for drug manufacturers, generic companies, CMOs, and packaging companies. Our translators understand FDA labeling requirements under 21 CFR Part 201 and the character-space constraints of multilingual packaging.
Documents We Translate
Prescribing information (USPI)
Full PI including Highlights, boxed warnings, indications, dosage, contraindications, adverse reactions
Medication guides
FDA-required patient documents for drugs with serious risks
Patient package inserts
Information sheets included with dispensed medications
Primary container labels
Bottle, vial, syringe, blister labels with drug name, strength, lot, expiration
Secondary packaging (carton text)
Drug facts, storage instructions, NDC information
Blister pack text
Foil and card printing with limited character space
OTC Drug Facts labels
Standardized Drug Facts panel per 21 CFR 201.66
Promotional labeling
Sales aids and detail pieces subject to FDA OPDP review
Why Pharma Labeling Translation Is Different
Space constraints
Our DTP team manages text expansion/contraction to fit fixed label dimensions
Regulatory terminology
Standardized pharmaceutical terms, not colloquial equivalents
Typographical precision
Drug names, strengths, and units must be exact
Product consistency
Terminology consistent across USPI, medication guide, container, and carton
Quality Assurance Process
Translation by specialist pharmaceutical linguist
Independent review by second specialist
Dedicated numerical and dosage verification
DTP layout adaptation with typeset proofreading
Final QC check against source
How It Works
Submit labeling files
InDesign, PDF, Word, or XML with target languages and packaging specs.
Quote within 2 hours
Word count and DTP complexity assessed.
Translation, review, and DTP
Full pharmaceutical QA process.
Certified delivery
Print-ready PDF, InDesign, XML, or Word.
48–72 Hour Labeling Turnaround Rush available
Need Pharmaceutical Labeling Translated?
Submit your labeling files for a free quote.
Frequently Asked Questions
Yes. Our DTP team adjusts font size, kerning, and layout to fit translations.
Yes. PDF, InDesign (IDML), and XML for packaging production.
Our translators follow 21 CFR Part 201 requirements.
Yes. Maintaining the FDA-prescribed format and terminology.
Medical Device Documentation Translation Services
- ISO 17100
- ATA
- USCIS Accepted
- NAJIT
A mistranslated IFU can cause misuse. An inaccurate device label can lead to incorrect calibration. A poorly translated clinical evaluation report can delay clearance.
Translation AZ provides certified translation for device manufacturers, distributors, and regulatory consultants, combining medical terminology with technical precision for FDA requirements.
Documents We Translate
Instructions for Use (IFU)
Setup, operation, maintenance, cleaning, and sterilization
Device labeling
Labels including symbols per ISO 15223-1
510(k) submissions
Substantial equivalence analyses and performance data
PMA applications
Class III device clinical data and manufacturing documentation
Technical files
Design specs, risk analyses (ISO 14971), V&V reports
Clinical evaluation reports
Systematic assessments of clinical evidence
Post-market surveillance
Safety updates, adverse event analyses
User manuals
Comprehensive and abbreviated guides
Training materials
Clinical and technical training for HCPs
Service manuals
Documentation for biomedical engineers
Regulatory Framework
FDA 510(k)
Class II substantial equivalence
FDA PMA
Class III full clinical evidence
FDA De Novo
Novel device classification
QSR (21 CFR 820)
Quality management documentation
UDI
Unique Device Identification labeling
How It Works
Submit device documentation
Include classification and target regulatory market.
Quote within 2 hours
Technical complexity assessed.
Translation and review
Specialist medical device linguist.
Certified delivery
DTP available for IFUs and labeling.
2-Hour Quote Response Standard 24–72 hrs · Rush available
Need Medical Device Documentation Translated?
Submit for a free quote. We respond within 2 hours.
Frequently Asked Questions
Yes. Complete premarket notifications.
Yes. Including diagrams, callouts, and safety symbols.
Yes. Software UIs, help files, and IEC 62304 documentation.
Yes. Correct regulatory terminology for each market.
Patient Records & Medical Reports Translation Services
- ISO 17100
- ATA
- USCIS Accepted
- NAJIT
When a patient relocates to the US, their medical history travels in a language their new provider may not read. When USCIS requires a civil surgeon examination supported by foreign records, the translation must be certified and precise.
Translation AZ provides HIPAA-compliant certified translation for hospitals, clinics, insurance companies, immigration attorneys, and individual patients.
Documents We Translate
Hospital discharge summaries
Diagnosis, procedures, medications, and follow-up instructions
Pathology and lab reports
Histopathology, cytology, blood work, clinical lab results
Radiology reports
X-ray, CT, MRI, ultrasound, nuclear medicine imaging
Surgical reports
Operative notes, findings, post-operative instructions
Medical histories
Comprehensive patient histories and examination records
Referral letters
Physician-to-physician correspondence
Vaccination records
Immunization histories including CDC-schedule vaccines
Prescription records
Medication lists and pharmacy records
Mental health records
Psychiatric evaluations, psychological assessments
Dental records
Dental charts, treatment plans, radiographs
Medical certificates
Fitness-for-duty, disability assessments, life insurance medicals
HIPAA Compliance
Business Associate Agreements (BAAs) with healthcare clients
Encrypted transmission and storage of all records
Access restricted to assigned translator and reviewer
HIPAA-trained translators and project managers
Secure destruction of PHI upon completion
Common Use Cases
USCIS immigration medicals — Vaccination records and medical histories for Form I-693 with USCIS-accepted certification.
Continuity of care — Complete records for patients relocating to the US.
Insurance claims — Hospital records and clinical reports for claims adjudication.
Medical malpractice litigation — Translated records and expert opinions for court proceedings.
How It Works
Submit medical records
HIPAA-compliant upload. Include purpose.
Quote within 2 hours
Volume and complexity assessed.
Translation and review
Specialist medical linguist with clinical accuracy review.
Certified delivery
Via encrypted channels.
2-Hour Quote Response Standard 24–72 hrs · Rush available
Need Medical Records Translated?
HIPAA-compliant handling guaranteed. Submit for a free quote.
Frequently Asked Questions
Yes. BAAs, encrypted transmission, access controls, and HIPAA-trained staff.
Yes. Vaccination records and I-693 supporting documents with USCIS-accepted certification.
Cardiology, oncology, orthopedics, neurology, psychiatry, OB/GYN, pediatrics, emergency medicine.
Yes. Experienced with handwritten clinical notes from healthcare systems worldwide.
Informed Consent & Patient-Facing Materials Translation Services
- ISO 17100
- ATA
- USCIS Accepted
- NAJIT
A patient who signs a consent form in a language they don't fully understand has not truly given informed consent. Translated patient materials are a compliance requirement and a patient safety measure.
Translation AZ provides certified translation for hospitals, health systems, clinics, IRBs, and healthcare communication agencies. Our translators combine clinical expertise with health literacy awareness.
Documents We Translate
Surgical consent forms
Procedure descriptions, risks, benefits, and alternatives
Treatment consent forms
Consent for treatments, therapies, and diagnostics
HIPAA authorization forms
Patient authorization for PHI use and disclosure
Advance directives
Living wills, healthcare proxies, DNR orders
Patient education brochures
Condition-specific guides and wellness information
Post-operative instructions
Discharge instructions, wound care, medication guides
Rehabilitation guides
PT/OT instructions and home exercise programs
Hospital signage
Multilingual navigation, safety, and patient rights signage
Patient portal content
Translated EHR patient portal content
Community health materials
Public health campaigns and disease prevention
Health Literacy and Cultural Adaptation
Reading level assessment
Targeting 6th–8th grade for general patient communications
Cultural sensitivity review
Adapting references and imagery for target communities
Plain language principles
Clear, direct language avoiding unnecessary jargon
Visual consistency
Translations work with original design elements
IRB Compliance
For research consent forms, IRBs require accurate translations. We provide certified translations, back-translations for IRB review, certificates of translation, and version-controlled documents aligned with protocol amendments.
How It Works
Submit materials
Include target population and reading level requirements.
Quote within 2 hours
Health literacy and cultural adaptation needs assessed.
Translation and review
Clinical accuracy and readability review.
Certified delivery
DTP available for brochures and signage.
2-Hour Quote Response Standard 24–72 hrs · Rush available
Need Patient Materials Translated?
Submit for a free quote. We respond within 2 hours.
Frequently Asked Questions
Yes. Certified translations with back-translations and certificates for IRB files.
Yes. Targeting 6th–8th grade reading level for general patient communications.
Yes. Appointment reminders, lab results, medication instructions, messaging templates.
Yes. Ensuring translated versions match original visual design.
Healthcare Compliance & Policy Translation Services
- ISO 17100
- ATA
- USCIS Accepted
- NAJIT
HIPAA governs privacy. The Joint Commission sets accreditation standards. CMS imposes Conditions of Participation. When healthcare institutions serve multilingual workforces, compliance documentation must be accessible.
Translation AZ provides certified translation for hospitals, health systems, long-term care facilities, behavioral health providers, and home health agencies.
Documents We Translate
HIPAA policies and procedures
Privacy, security, breach notification, BAA templates
Joint Commission documentation
Accreditation policies, National Patient Safety Goals, corrective actions
CMS Conditions of Participation
Policy manuals for hospitals, SNFs, home health
Standard operating procedures
Clinical, administrative, and safety SOPs for multilingual staff
Quality management documentation
QI plans, metrics, root cause analyses, patient safety reports
Infection control protocols
Isolation precautions, hand hygiene, PPE guidance, outbreak response
Staff training materials
Compliance training, orientation, competency assessments
Risk management documents
Incident reporting, liability assessments, risk mitigation
Credentialing documentation
Medical staff bylaws, credentialing applications, privileging
Patient rights and responsibilities
Patient bill of rights required by regulation
Language Access Compliance
Under Title VI, Section 1557 of the ACA, and related regulations, healthcare institutions receiving federal funding must provide meaningful access to LEP individuals. This includes translated consent forms, patient rights notices, complaint procedures, and eligibility notices.
We support healthcare institutions in meeting language access requirements by translating vital documents into the languages their patients speak.
How It Works
Submit compliance documents
Policies, SOPs, or training materials.
Quote within 2 hours
Regulatory context and target languages assessed.
Translation and review
Specialist healthcare linguist with independent review.
Certified delivery
Formatted to match your policy templates.
2-Hour Quote Response Standard 24–72 hrs · Rush available
Need Healthcare Compliance Documents Translated?
Submit for a free quote. We respond within 2 hours.
Frequently Asked Questions
Yes. Privacy, security, breach procedures, and staff training.
Yes. Accreditation policies, corrective actions, and survey preparation.
Yes. Vital documents including patient rights notices, consent forms, and complaint procedures.
Yes. Isolation precautions, hand hygiene, PPE, and outbreak response for multilingual staff.