Contents of Business
Since the revisions to the Pharmaceutical Affairs Act in Japan in 2005, changes have happened in the access to the Japanese markets of domestic pharmaceuticals on its system. And the inspections of quality-related agreements between importers and manufactures have grown increasingly rigorous. Following the change of maket demand, 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 get approved by the GMP audit.