Medical Regulatory Translation Services | Regulatory Documentation & Life Sciences Translation
Specialist medical regulatory translation services for pharmaceutical and medical device companies — delivered by RABT Global’s expert regulatory team.
Medical regulatory translation services and regulatory documentation services are essential components of any multi-market regulatory programme. When entering new markets, regulatory compliance depends not only on meeting technical submission requirements but on ensuring that all regulatory documentation — from technical files and dossiers to IFUs, labeling, and patient information — is accurately translated and regulatory-compliant in the target language. At RABT Global, our life sciences translation services combine specialist medical and scientific translation expertise with regulatory affairs knowledge — ensuring every translated document meets both linguistic and regulatory compliance standards.
How RABT Global Delivers This Service
Initial Consultation & Needs Assessment
We review your specific medical regulatory translation services requirements, target markets, and timelines to scope the engagement.
Strategy & Planning
Our specialist team develops a tailored approach aligned with applicable regulatory requirements and your commercial objectives.
Delivery & Execution
We execute the defined scope — producing regulatory-compliant deliverables to the highest quality standards.
Review & Quality Assurance
All deliverables undergo independent review and quality check before client delivery.
Ongoing Support
RABT Global remains available for follow-up queries, regulatory authority interactions, and lifecycle support.
Our Translation & Documentation Services
IFU Translation Services
Instructions for Use translation for EU MDR compliance across all EU official languages
MDR/IVDR Technical Documentation Translation
EU MDR technical file and performance evaluation translation
Medical Labeling Translation Services
SmPC, PIL, IFU, and outer carton translation for regulatory submissions
Regulatory Documentation Services
full regulatory dossier translation management for global market entry
Regulatory Compliant Translations
translations validated against applicable regulatory terminology standards
Multilingual Regulatory Documentation
coordinated translation programme management for multi-country submissions
Technical Documentation Translation
QMS documentation, SOPs, and quality records translation for international operations
Medical Device Translation Services
device-specific regulatory document translation across 40+ language pairs
What are Translation & Documentation Services?
Translation & Documentation Services provide life sciences companies with specialist medical regulatory translation services expertise — supporting regulatory compliance, market access, and product lifecycle management across pharmaceutical and medical device sectors. RABT Global’s medical regulatory translation services are delivered by qualified regulatory professionals with deep expertise in FDA, EMA, MHRA, CDSCO, and global regulatory requirements.
Translation & Documentation Services — FAQs
A: RABT Global’s IFU translation services cover all EU official languages as required by EU MDR 2017/745 — including French, German, Spanish, Italian, Portuguese, Dutch, Polish, Czech, Swedish, Danish, Finnish, Greek, Hungarian, Romanian, Bulgarian, and all other EU member state languages. We also provide IFU translation for Middle Eastern markets (Arabic), Asian markets (Mandarin, Japanese, Korean), and other global destinations.
A: All RABT Global regulatory compliant translations are produced under a formal quality process: (1) translation by a subject matter expert with medical/scientific qualifications, (2) independent review by a second qualified translator, (3) regulatory compliance check against applicable terminology standards and health authority requirements, and (4) final quality sign-off. Our translation quality management process is ISO-aligned and documented for audit purposes.
A: RABT Global combines specialist medical regulatory translation services expertise with a proven track record across 200+ global clients. Our regulatory team brings multi-jurisdictional knowledge, integrated regulatory and medical writing capabilities, and a genuine partnership approach — making us the medical regulatory translation services provider of choice for pharmaceutical and medical device companies worldwide.
Expert Translation & Documentation Services — Partner with RABT Global
Get specialist medical regulatory translation services from RABT Global’s expert regulatory team. Trusted by 200+ life sciences companies worldwide.