Regulatory Affair / Quality Control

The Regulatory Compliance & Quality Assurance Dept. provides support for the APIs that SPI sells to customers in Japan, including Foreign Manufacturer Accreditation (FMA) required by the Pharmaceutical Affairs Law, Master File (MF) registration, GMP compliance inspection at API manufacturing facilities in Japan and other countries, and manufacturer/seller audit support.

We also have more than 30 different pieces of testing equipment, including powder X]ray diffraction equipment and electron microscopes, at our own lab where we engage in quality checks, shipment inspection testing, establishment of specification/testing methods, etc.

When API manufacturers export APIs to Japan, there is a hurdle to overcome in the form of legal restrictions. We provide pharmaceutical support to customers in Japan wishing to start trading APIs based on our extensive experience.