Sogo Trading’s advantage

Inspections and Consulting

Inspections of foreign manufacturers by the PMDA are divided into those performed in writing and those done onsite, with the submission of documents in advance serving as the first step for both of these. Sogo Trading undertakes the preparation of documents to be submitted to PMDA, which includes communicating with PMDA, requesting the submission of documents from foreign manufacturers and translating documents that have been submitted in the local language, preparing summaries, and creating tables. In terms of the second step, as a matter of course we accompany onsite inspections, offer guidance to foreign manufacturers on ways of dealing with the inspections from our prior experience, and provide support to help them be graded as being in conformance. Our expert staff promptly carries out everything through the creation of draft responses to inquiries from and items indicated by the PMDA, instructions to foreign manufacturers, corrections for replies, and the submission of replies up through the very end.