Japanese Medical Translation Services

Yes. Our Japanese medical translators have direct experience with PMDA-specific documentation formats and the technical terminology required for Japanese drug and device approvals.

We create a project-specific glossary at the outset and use CAT tools and translation memories to enforce consistent Japanese terminology across all dossier documents.

Yes. We handle both directions with equal quality. Japanese to English is common for reporting and company filings; English to Japanese is common for clinical trial and regulatory documents entering the Japanese market.

Japan's Pharmaceuticals and Medical Devices Agency (PMDA) and Ministry of Health, Labour and Welfare (MHLW) use specific Japanese-language document structures and terminology conventions that differ from EMA and FDA formats. Our PMDA translators follow the Japanese CTD format requirements and the GPMSP (Good Post-Marketing Study Practice) guidelines, applying correct kanji and katakana conventions for drug names, dosage terminology, and adverse event classification throughout.

A standalone Japanese informed consent form of 2,000 to 4,000 words typically delivers in 2 to 3 business days including QA. Japanese informed consent forms tend to be longer than European equivalents due to PMDA requirements for detailed procedural explanation; factor approximately 20 to 30 percent more word count compared to an English or EU source document. For multi-country studies running Japanese in parallel with Korean, Chinese, and English we assign a dedicated project manager to align all language timelines.