Medical translations where precision saves lives
When it comes to health there can be no compromises. We know that patients' lives are in the hands of doctors, pharmacists and other medical personnel. That is why we strictly comply with all regulations, including country-specific ones.
Request a medical translationLife-critical precision
No compromises when health is at stake
Regulatory compliance
EMA, FDA, MHRA and more
Strict data security
Password-protected, archived access
Medical specialists
Translators with medical training
We follow every regulation that matters
We carefully follow and ensure compliance with all national and international amendments and developments in the medical and pharmaceutical field.
European Medicines Agency (EMA)
Full compliance with EMA guidelines for pharmaceutical documentation, clinical trial submissions, and marketing authorisation applications
US Food and Drug Administration (FDA)
Adherence to FDA requirements for drug labelling, device submissions, and clinical documentation in the US market
Code of Federal Regulations (Title 21)
Chapter I: FDA regulations governing food, drugs, biologics, medical devices, and electronic products
Structured Product Labelling (SPL)
Translations in accordance with FDA provisions for standardised drug labelling and product information
UK MHRA
Compliance with the Medicines and Healthcare Products Regulatory Agency requirements for the UK market
Japanese Ministry of Health
Adherence to the Ministry of Health, Labour and Welfare guidelines for pharmaceutical and medical device submissions
Where medical expertise meets linguistic precision
We choose expert translators who have completed the necessary medical training. All translators must pass our tests, and are regularly provided with further training and information on developments in the field.
One of our departments specialises solely in the translation of marketing texts from the fields of natural sciences and medicine.
What sets us apart
- Translators with completed medical training
- Regular testing and ongoing professional development
- Compliance with EMA, FDA, MHRA, and more
- ISO 27001 certified data security
- Password-protected, documented, and archived access
- Dedicated life sciences marketing translation team
- ISO 9001 and ISO 17100 certified quality assurance
Medical documents we specialise in
From clinical trial documentation to patient-facing materials, we cover the full spectrum of medical and pharmaceutical translation.
Clinical documentation
Clinical trial protocols, investigator brochures, informed consent forms, and case report forms.
Patient-reported outcomes
PRO instruments, quality-of-life questionnaires, patient diaries, and validated assessment tools.
Regulatory submissions
Marketing authorisation applications, CTD modules, safety reports, and pharmacovigilance documentation.
Product labelling & packaging
SmPCs, patient information leaflets, product labels, and structured product labelling documentation.
Medical devices
Instructions for use, technical files, risk assessments, and CE marking documentation for medical devices.
SOPs & operational docs
Standard operating procedures, contracts, agreements, worksheets, and medical forms and records.
Drop us a line
Tell us about your medical translation project and we'll match you with the right specialist.
Request a quote
Questions about medical translation
Everything you need to know about our medical translation services.
Medical documents directly impact patient safety. A mistranslation in a drug label, clinical protocol, or device instruction can endanger lives. Our translators have completed medical training and must pass rigorous tests before working on any medical project.
We ensure compliance with the European Medicines Agency (EMA), US FDA including Title 21 CFR, Structured Product Labelling provisions, UK MHRA, and the Japanese Ministry of Health, Labour and Welfare. We stay current with all amendments and developments.
We are ISO 27001 certified. We guarantee complete confidentiality with limited, documented and archived access to data. All data are password-protected and stored on our secure web server.
Yes. Our translators have experience translating PRO instruments following linguistic validation methodology: forward translation, reconciliation, back translation, cognitive debriefing, and harmonisation to ensure cross-cultural equivalence.
We translate clinical trial documentation, regulatory submissions, SmPCs, patient information leaflets, device IFUs, SOPs, contracts, case report forms, medical forms, marketing texts for life sciences, and more — in over 30 languages.
All translators are regularly provided with further training and information on medical developments. We ensure they are always acquainted with the latest regulatory changes relevant for your products and services, including new EMA and FDA guidance.
Yes. We translate instructions for use, technical files, risk assessments, performance evaluations, and CE marking documentation in compliance with the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
We cover over 30 languages with particular strength in the Adriatic region: Slovenian, Croatian, Serbian, Bosnian, Italian, plus all major European and selected Asian languages.
Need a medical translation?
Tell us about your project and we'll match you with a specialist medical translator. Over 30 languages, ISO-certified quality, full regulatory compliance.
Get a free quote