Life sciences
Life sciences translation that accelerates submissions and protects patients
GxP-ready language solutions for pharma, biotech, and MedTech teams. We help you meet FDA, EMA, and NMPA requirements with audit-ready precision, from the first consent form to post-market safety reporting.
Exemplar 50 mgfilm-coated tablets
3Dosage and administration
Take one tablet by mouth twice daily with food. Do not take more than 2 tablets in 24 hours.
Keep out of the reach of children.
Rev. 04Glossary-controlled terminology
- GxPReady workflowsTranslate, edit, proof, with back-translation on request
- ISO9001 and 17100Certified quality and translation management
- eCTDRegulatory submissionsLabeling, SmPC, and dossiers for FDA, EMA, and NMPA
- 24/7Safety reportingRapid adverse event translation for pharmacovigilance
Trusted by pharma, health systems, and agencies including
Lifecycle coverage
Validated solutions across the product lifecycle
The documents we translate at each phase, from first patient in to post-market surveillance.
| Document set | Clinical trials | Regulatory submission | Launch | Post-market |
|---|---|---|---|---|
| Informed consent forms and patient materials | ||||
| eCOA and ePRO instruments | ||||
| Protocols, investigator brochures, and CSRs | ||||
| eCTD modules, labeling, and SmPC | ||||
| IFUs, device UI, and technical manuals | ||||
| Adverse event reports and safety updates | ||||
Clinical trial documentation
From informed consent forms to clinical study reports, culturally adapted, patient-centered communication that supports enrollment and protects data integrity.
Regulatory submission localization
High-stakes translation of eCTD submissions, labeling, and the Summary of Product Characteristics (SmPC) for approval across global markets.
Pharmacovigilance and safety
Rapid-response translation of adverse event reports and post-market surveillance documents to maintain compliance and patient safety.
MedTech and device localization
Instructions for use (IFUs), device interfaces, and technical manuals for Class I, II, and III medical devices.
Therapeutic area expertise
Your science is complex. Your translators should be too.
We don’t use generalists. Your content is handled by subject-matter linguists with medical and scientific backgrounds in your therapeutic area.
Oncology
Trial protocols, consent forms, and safety narratives for cancer research.
Neurology
Cognitive assessments, patient diaries, and scales that must stay valid in every language.
Immunology
Mechanism-heavy content where every term must match the source science.
Rare disease
Small, global patient populations where every participant’s understanding counts.
How we work
Built for compliance, engineered for speed
Linguistic validation for patient-facing content, protected data, and assets that scale across global trials.
Linguistic validation workflow
Forward translation
A subject-matter linguist translates the source.
Expert review
A second linguist edits against the source and glossary.
Back-translation
An independent linguist translates it back into the source language.
Reconciliation
Differences are resolved and documented for your file.
Final proof
Formatting, numbering, and layout are checked before delivery.
Data integrity and security
Pre-clinical data and patient information move only through our encrypted client portal, never open email. Patient information is handled under our HIPAA compliance program and a signed Business Associate Agreement, every linguist is background-checked and bound by a strict NDA, and access is limited to your project team.
Scalability for global trials
Centralized translation memory and glossaries keep terminology consistent across multi-site trials, reducing cost and shortening submission timelines.
Free resource
Download the Global Regulatory Compliance Checklist
A two-page guide for regulatory affairs directors to confirm linguistic readiness for FDA, EMA, and NMPA submissions, and find gaps in your documentation before they become findings.
- Language requirements by authority
- Terminology and template controls
- Linguistic validation and audit records
- Format, data security, and timeline checks
Case studies
Results in health and life sciences
How health agencies, providers, and medical device programs have used our translators and interpreters.
-
Government and defense U.S. Army
We provided specialized translation services, leveraging a team of expert linguists with experience in medical and technical fields. Read the case study -
Health care Centers for Disease Control and Prevention
To address the language barrier challenges faced by CDC employees working abroad, TE has implemented a comprehensive language training program. Read the case study -
Health care Insight Vision Group
We address this challenge by providing on-site interpreters who are fluent in both English and the patient's native language. Read the case study
Regulatory strategy consultation
Ready to de-risk your next global submission?
Share the documents, markets, and submission or site activation dates. We confirm the linguists, the validation steps, the timeline, and the price before work begins.
Safety report due? Say so up front. Our 24/7/365 global team supports pharmacovigilance deadlines.
Life sciences requestExample details
- Program
- Phase III trial, 9 countries
- Need
- ICFs with back-translation, 11 languages
Explore more
Related services
Regulated translation, device localization, and interpreting for the full product lifecycle.
FAQ
Life sciences translation, answered
Don’t see your question? A language specialist can answer it in one call.
Talk to a specialist
Get a straight answer
Tell us what you need translated or interpreted, and we’ll scope it with you.
Meet one-on-one with a language services expert, at a time that suits you.
How do you ensure translation accuracy for clinical trials?
Patient-facing content can go through linguistic validation: forward translation, expert review, independent back-translation, and reconciliation, so the participant’s understanding in the target language matches the original clinical intent.
Are your services ISO-certified?
Yes. Translation Excellence is certified to ISO 17100 for translation services and ISO 9001 for quality management.
Can you handle rapid turnaround for adverse event reporting?
Yes. Our 24/7/365 global team supports pharmacovigilance teams with rapid translation of adverse event reports, so they can meet expedited 7-day and 15-day regulatory reporting deadlines.
Do you localize eCOA and ePRO instruments?
Yes. We localize electronic clinical outcome assessments and patient-reported outcome instruments so trial participants worldwide have a consistent experience.
Which regulatory documents do you translate?
eCTD modules, labeling, Summary of Product Characteristics (SmPC), patient information leaflets, investigator brochures, protocols, and clinical study reports for FDA, EMA, NMPA, and other authorities.
Do you translate medical device documentation?
Yes. We translate instructions for use (IFUs), device user interfaces, labels, and technical manuals for Class I, II, and III medical devices.
How do you protect patient and trial data?
Files move only through our encrypted client portal, never open email. Patient information is handled under our HIPAA compliance program and a signed Business Associate Agreement, every linguist is background-checked and bound by a strict NDA, and access is limited to the people assigned to your project.
Tell us what’s at stake. We’ll show you how we’d handle it.
Send your files or describe your event. A language specialist replies with a fixed quote and a delivery date, with no obligation.
Prefer to call? 720-325-0459