SAKURA FACTORY

Located in Sakura City, Chiba Prefecture, our factory is one of the few facilities in Japan dedicated to the development and manufacture of radioactive in vitro diagnostics (IVD). Because we handle radioactive isotopes, we possess specialized expertise in radiation management and operational techniques (including the manufacture, storage, safety management, and transport of radioactive reagents, as well as employee training).

Our Commitment to Product Quality and Safety Management

We have established a quality management system in accordance with the Ministry of Health, Labour and Welfare’s QMS Ordinance and ISO 13485, and we are committed to ensuring product quality and safety. We also comply with relevant laws and regulations, as well as industry guidelines such as the “The Code of Ethics for Corporate Activities of In Vitro Diagnostics Companies” and the “In Vitro Diagnostic Products Promotion Guidelines,” and conduct our business with a high degree of transparency and ethical integrity.

Quality and Safety Management and Operations

Developing and implementing a Quality Management Policy (ISO 13485 certification, QMS Ordinance,and QMS Committee) in accordance with the Ministry of Health, Labour and Welfare QMS Ordinance
Developing and implementing a Quality Manual and Purchasing Procedures
Creating and maintaining supplier lists and supplier re-evaluation documents and records
Managing Radioisotopes (RI)
Ensuring safe and proper handling in compliance with laws and regulations and under a strict management system
Developing and implementing regulations and related rules for the Institutional Review Board(IRB)

Strengthening the Quality Management System Through ISO 13485 Certification

Denis Pharma obtained ISO 13485 certification in March 2015, a quality management standard specifically applicable to medical devices and in vitro diagnostics (IVD). This certification was pursued to achieve smoother and more systematic operations by restructuring our operational systems in anticipation of new product launches and operational efficiency improvements.