Sogo Trading’s advantage

Quality Assurance Structure

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.