Since the revisions to The Law on Securing Quality Efficacy and Safety of Prodects Including Pharmaceuticals and Medical devices in 2014, inspections of quality-related agreements between importers and manufactures/distributors（Marketing Authorization Holder、MA holder） have grown more rigorous in Japan, but also regarding Good Quality Practices (GQP) contracts between foreign manufacturers, importers, and MA holder in cases where pharmaceuticals and APIs are imported from a foreign manufacturer.
Our experts in charge of pharmaceutical affairs provide support through our full-scale structure to ensure that the customer proceeds smoothly through to the conclusion of a contract. What is more, we also provide advice that helps our manufacturers to be graded as being in conformance. This includes onsite inspections related to quality assurances for manufacturers and distributors aimed at foreign manufacturers, accompanying onsite inspections by the Pharmaceuticals and Medical Devices Agency (PMDA), and providing guidance on how to improve the indicated items.

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.

We not only import and export products, but are also further burnishing our capabilities for providing accurate and ample information with regards to the latest company information, revisions to laws and ordinances, product marketing trends, markets, and more in local regions. This is being done by our Chinese staff at Sogo Trading and our Japanese-speaking Chinese staff at our affiliate company of SPC (ShangHai) Co., Ltd. We work to promptly provide the latest information in a consistent manner, including everything from the stages of providing samples to manufacturer inspections, research and development, price negotiation, guaranteeing high quality, and the importation and exportation of products.
We receive various data and provide reports to our customers via our partner companies, with which we have built up satisfactory relationships of trust through many years of dealings with them in Europe .