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TranslateBE.
Specialities/Medical Translation
✦ Pharmaceutical · Clinical · Regulatory · Medical Devices

Medical Translation & pharmaceutical

Clinical trials, MAA dossiers, pharmaceutical package inserts, medical records: our physician-translators guarantee vital precision and absolute regulatory compliance in 70+ languages.

✓ Physicians & pharmacists✓ ICH · GCP · GMP✓ EMA · FDA · MHRA✓ 70+ languages
Our expertise

Medical translation:
where precision is a matter of life

Medical translation is one of the most demanding and critical disciplines there is. An error in a drug dosage, an ambiguity in a consent form, or an inaccuracy in a regulatory dossier can have direct consequences on patient safety and on product approval.

At TranslateBE, our medical translators are qualified physicians, pharmacists or biologists. They have worked in clinical environments, pharmaceutical laboratories, or regulatory agencies. They are fully versed in ICH guidelines, Good Clinical Practice, and the requirements of global health authorities — EMA, FDA, ANSM, AFMPS.

Vital precision: In medical translation, every term matters. Dosages, INNs, contraindications, clinical protocols, our physician-translators apply absolute rigour to every document to protect patient safety.

Medical and pharmaceutical translation

Physician & pharmacist translators

EMA · FDA · AFMPS · ICH compliant

Documents handled

All your medical documentation translated

From clinical trials to regulatory dossiers, from patient leaflets to medical equipment.

Clinical Studies & Research

  • Clinical trial protocols (phases I–IV)
  • Clinical study reports (CSR)
  • Investigator brochures
  • Informed consent forms
  • Medical publications & journal articles

Regulatory & Registration

  • MAA dossiers (marketing authorisation applications)
  • Package inserts & summaries of product characteristics (SmPC)
  • Pharmacovigilance reports (PSUR)
  • Medical device dossiers (CE marking)
  • FDA & EMA submissions

Medical Documentation

  • Medical records & discharge summaries
  • Prescriptions & medication orders
  • Imaging & laboratory reports
  • Good practice guidelines (GMP, GCP)
  • Medical equipment manuals & data sheets

Patient & Communication

  • Patient information leaflets & brochures
  • Patient-reported outcome instruments (PRO)
  • Medical mobile applications
  • Continuing medical education materials
  • Chemical safety data sheets

Medical specialities covered

From cardiology to neurology, from pharmacology to genetics, our medical experts cover all clinical and pharmaceutical specialities.

Cardiology & Cardiovascular
Neurology & Psychiatry
Pharmacology & Oncology
Genetics & Biotechnology
Biology & Microbiology
General Medicine & Paediatrics
Pharmaceutical Chemistry
Anaesthesiology & Intensive Care

Also covered:

EndocrinologyDermatologyOphthalmologyRheumatologyGastroenterologyUrologyGynaecologyToxicologyDental medicineElectrodiagnosticsEndoscopyBiostatistics
Our process

Clinical rigour, applied to translation

1

Medical analysis

We identify the exact medical speciality, document type, and regulatory requirements (ICH, GCP, GMP…) to select the most qualified medical translator from our expert network.

2

Expert physician-translator

Your document is translated by a qualified physician, pharmacist, or biologist, specialised in your clinical or pharmaceutical domain and with experience in a medical or regulatory environment.

3

Dual medical review

A second medical expert verifies the clinical terminology, dosages, molecule names (INN), biological values, and compliance with the regulatory guidelines of the target country.

4

Certified delivery

Delivery in the required format (Word, PDF, eCTD for regulatory submissions). Certification available for documents destined for health authorities or courts.

Why TranslateBE?

Your guarantees for medical translation

Physician & pharmacist translators

Our medical translators are qualified physicians, pharmacists, biologists, or nurses. They have worked in hospitals, pharmaceutical laboratories, or regulatory bodies. They understand pathologies, mechanisms of action, and clinical protocols.

Vital precision guaranteed

In medicine, a translation error can have consequences for patient safety. Dosages, international non-proprietary names (INN), dosing regimens, contraindications: every critical piece of data is verified with absolute rigour by our experts.

70+ medical languages

English, German, Spanish, Japanese, Mandarin, Arabic, Russian and 60+ other languages. We cover global pharmaceutical and medical markets for your international regulatory submissions.

ICH, GCP & GMP compliance

Our translators are versed in ICH guidelines, Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and the requirements of health authorities (EMA, FDA, ANSM, AFMPS). Your dossiers comply with international standards.

WHO/INN standardised terminology

We systematically use WHO International Non-proprietary Names (INN), ICD-10/ICD-11 codes, and MedDRA and SNOMED terminologies. Your documents comply with globally recognised terminological standards.

Regulatory deadlines met

MAA submission, EMA or FDA deadline, medical conference date: we handle pharmaceutical emergencies with dedicated teams available 7 days a week. Our express turnaround guarantees that your regulatory milestones are always met.

Indicative rates

Competitive rates for the healthcare sector

Per-word pricing for volumes, flat-rate for regulatory dossiers. Free quote within 2 hours.

Medical documentation

from €0.14

/ word

Leaflets, manuals, medical articles

Clinical trials & MAA

from €0.17

/ word

Protocols, CSRs, regulatory dossiers

Large pharma projects

On request

CTD/eCTD, EMA/FDA submissions

Indicative prices (all-inclusive). Minimum order: €50. Urgent surcharge applies. Preferential rates for public hospitals & university hospitals.

FAQ

Your questions about medical translation

✦ Physician translators · ICH/GCP · EMA · FDA · AFMPS

Your patients' health deserves the best

Clinical trials, MAA dossiers, pharmaceutical leaflets, medical records: our physician-translators guarantee vital precision and perfect regulatory compliance in 70+ languages.

No commitment · NDA included · Preferential hospital rates · Secure payment