Medical Translation Services — Regulatory-Compliant Medical Translations Worldwide
Sub-headline: RABT Global delivers expert medical translation services for pharmaceutical regulatory submissions, medical device documentation, and life sciences communications. Accurate, regulatory compliant medical translations across 40+ language pairs.
Expert regulatory medical translation services and multilingual medical documentation for your regulatory submissions and product launch.
Medical translation services are essential for any life sciences company operating across multiple markets. Whether you need IFU and labeling translation for a medical device entering the EU market, pharmaceutical translation services for a regulatory dossier submission, or clinical trial translation services for a multi-country study, the accuracy and regulatory compliance of your translations directly impacts the quality of your regulatory submissions and the safety of your products.
At RABT Global, our medical translation services are delivered by specialist translators with dual expertise in life sciences and regulatory affairs — not generic translation agencies. Our regulatory medical translation services are performed by subject matter experts who understand the regulatory context of every document they translate, ensuring accuracy, consistency, and full regulatory compliance across all target languages.
Our life sciences translation services cover the full spectrum of pharmaceutical, medical device, and clinical research documentation — from multilingual medical documentation for EU regulatory submissions to certified medical translation services for GCC and CDSCO regulatory filings. All translations are subject to our quality management process, including independent linguistic review and regulatory compliance verification.
Our Medical Translation Services
KEY SERVICES — MEDICAL TRANSLATION
Pharmaceutical Regulatory Dossier Translation
CTD module translation, SmPC, PIL, and clinical study report translation
Medical Device IFU & Labeling Translation
IFU translation to EU MDR Article 10 requirements, across all EU official languages
Clinical Trial Translation Services
protocol translations, patient information sheets, consent forms, and investigator materials
Regulatory Compliant Medical Translations
translation with full regulatory terminology accuracy and consistency
MDR/IVDR Technical Documentation Translation
EU MDR technical file and CER translation services
Multilingual Medical Documentation
ongoing translation management for multi-market product portfolios
Certified Medical Translation Services
certified translations for regulatory submissions, legal proceedings, and market authorisations
Pharmacovigilance Document Translation
PSUR, PBRER, and ICSR translation for global pharmacovigilance obligations
Medical Translation Language Pairs — 40+ Languages
| Region | Languages Covered |
|---|---|
| European Union | French, German, Spanish, Italian, Portuguese, Dutch, Polish, Czech, Swedish, Danish, Finnish, Hungarian, Romanian, Bulgarian, Greek, and all other EU official languages |
| Middle East / GCC | Arabic (Gulf/MSA) — Saudi Arabia, UAE, Kuwait, Qatar, Bahrain, Oman |
| Asia-Pacific | Mandarin Chinese, Japanese, Korean, Hindi, Urdu |
| Emerging Markets | Turkish, Russian, Indonesian, Vietnamese, Thai |
| Certification | Certified translations available for all major regulatory markets |
What are Medical Translation Services in Regulatory Affairs?
Medical translation services in regulatory affairs involve the accurate, regulatory-compliant translation of pharmaceutical, medical device, and clinical research documentation into target languages required for regulatory submissions and product labeling. These services include IFU and labeling translation, CTD dossier translation, clinical trial document translation, and SmPC/PIL translation — performed by specialist translators with both life sciences expertise and regulatory affairs knowledge.
Medical Translation Services — FAQs
A: Medical and regulatory documents contain highly technical, context-specific terminology where errors can have serious consequences — both for patient safety and regulatory compliance. General translation agencies lack the specialist knowledge needed to ensure accuracy in regulatory contexts. RABT Global’s regulatory medical translation services use subject matter experts in pharmaceutical and device sciences to deliver translations that are both linguistically accurate and scientifically correct.
A: All RABT Global medical translation services are performed under a formal quality management process including: (1) translation by a qualified subject matter expert, (2) independent review by a second qualified translator, (3) regulatory compliance check against applicable requirements, and (4) final proofread. This four-step process ensures the highest quality across all language pairs.
A: Yes. Our medical device translation services include IFU and labeling translation for EU MDR compliance — covering all EU official languages as required by EU MDR 2017/745 Article 10(11). We manage multilingual IFU projects as a single coordinated programme, ensuring consistency across all language versions and compliance with EU MDR symbol and formatting requirements.
A: Yes. RABT Global provides certified medical translation services for regulatory submissions, market authorisation applications, and legal purposes. Certified translations include an official statement of accuracy and completeness, signed by a qualified translator. Certification formats are adapted to the requirements of the specific health authority or regulatory context.
Regulatory-Compliant Medical Translations — Delivered by Life Sciences Specialists
Expert medical translation services across 40+ languages. Pharmaceutical, device, and clinical documentation — accurate, compliant, and on time.