Clinical trial documents, PMDA submissions, medical device documentation, and pharmaceutical materials translated by Japanese-speaking medical specialists.
Japan's Pharmaceuticals and Medical Devices Agency (PMDA) has specific translation and documentation requirements that differ from EMA and FDA standards. Our Japanese medical translators hold medical or pharmaceutical qualifications and are experienced in PMDA approval processes, GPMSP guidelines, and ICH harmonized standards as applied in Japan.
Translators experienced with PMDA submission requirements, GPMSP guidelines, and Japan-specific pharmaceutical regulations.
All Japanese medical translations handled by translators with degrees in medicine, pharmacy, or life sciences.
Translation, specialized medical editing, and final review against validated Japanese medical terminology.
Full clinical trial dossiers and ongoing pharmacovigilance programs handled by dedicated project teams.
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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.
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