Korean Medical Translation Services

Yes. We have experience producing Korean-language dossiers for MFDS drug registration and medical device marketing authorization, following the specific formatting and terminology requirements of the Korean regulatory authority.

Yes. We translate clinical trial documentation in line with K-ICH guidelines and the relevant ICH guidelines adopted in Korea, ensuring regulatory compliance for Korean trial sites.

We build client-specific Korean medical glossaries and translation memories at project start and maintain them throughout the full regulatory dossier lifecycle, ensuring consistency across all modules and submissions.

Yes. Korea's Ministry of Food and Drug Safety (MFDS) requires CTD format submissions following K-ICH harmonization guidelines. Our translators apply MFDS-specific terminology conventions for drug classification, adverse event nomenclature, clinical trial phasing, and device risk class categories. For pharmaceutical products we confirm whether the submission falls under the domestic bioequivalence pathway or the new drug application pathway, as these have distinct Korean documentation requirements.

All translators and project managers sign GDPR-aligned data processing agreements before receiving any patient-identifiable or trial-confidential material. For Korean projects we additionally apply the Korean Personal Information Protection Act (PIPA) handling requirements. Files are transferred over encrypted channels and purged from our systems on project closure unless you request translation memory retention.