“Excellent service and good value translation company. Accurate, fast turnaround at competitive rates. Highly recommended for their outstanding communication and prompt responses.”
Claire C.
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Clinical trial protocols, MFDS regulatory submissions, medical device documentation, and patient materials translated by Korean medical specialists.
South Korea's Ministry of Food and Drug Safety (MFDS) is one of the most rigorous pharmaceutical and medical device regulatory authorities in Asia. Companies seeking Korean market approval must submit comprehensive Korean-language dossiers meeting MFDS-specific formatting and terminology requirements. Our Korean medical translators hold degrees in medicine, pharmacology, or biomedical sciences and are fully fluent in MFDS submission standards and K-ICH harmonization guidelines.
In-depth knowledge of MFDS drug and medical device registration requirements, including the KFDA predecessor standards that still govern some product categories.
Translation, editing by a second Korean medical linguist, and a final terminology check against MFDS-approved Korean medical glossaries.
Every Korean medical project is handled by a translator with a proven background in medicine, pharmacology, or biomedical sciences.
Documents are prepared in line with K-ICH guidelines and harmonized ICH standards applicable to Korean regulatory submissions.
Client Reviews
“Excellent service and good value translation company. Accurate, fast turnaround at competitive rates. Highly recommended for their outstanding communication and prompt responses.”
Verified Google Review
“The team was meticulous with scientific and academic terminology. They delivered a flawless translation of my doctoral thesis on time, and communication throughout was outstanding.”
Academic Translation Client
“My experience with BeTranslated was great. They respond quickly and I recommend the agency 100%.”
Verified Google Review
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.
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