Translation Services (ISO 17100)
ISO 17100–aligned professional translation and revision for regulatory dossiers, IFU/labels, clinical documents, and multilingual submissions.
Overview
High-stakes regulatory content demands accuracy, consistency, and traceability. Our translation workflows follow ISO 17100 principles: qualified linguists, mandatory revision by a second professional, and quality checks suited to medical device and pharmaceutical documentation. We support manufacturers and consultancies preparing multilingual packages for authorities and notified bodies.
Key Features
ISO 17100–oriented processes: qualified translators, revision, and documented QA
Regulatory and technical focus: CER/PSUR excerpts, labeling, SOPs, and submission-ready text
Terminology management and client-specific glossaries for consistent use of approved terms
Coordination with your RA team to align translations with approved source and market requirements
Key Benefits
Reduced risk of authority queries caused by translation errors or inconsistencies
Faster turnaround when translation is integrated with your regulatory timeline
Clear accountability through a structured translation–revision workflow
Scales from single documents to full multilingual registration packages
Ideal For
- Medical device and IVD manufacturers submitting in multiple languages
- Pharma and biotech teams localizing labels, PILs, and regulatory correspondence
- Regulatory consultancies outsourcing translation with defined quality expectations
- Startups and SMEs needing dependable translation without enterprise-only minimums
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