About Us
Quality and Compliance
Quality Policy
TEIJIN REGENET complies with laws and regulations and continuously improves its quality system in order to provide products and services that meet customer’s needs.
Responsible Officers
Officers who are responsible for regulatory affairs and division of duties (as of November 2023)
Research and Development | Pharmaceutical Affairs |
Manufacturing / Quality |
Compliance | |
---|---|---|---|---|
President Yasushi Tanaka |
〇 | 〇 | 〇 | 〇 |
Director Takashi Matsunaga |
〇 | 〇 | 〇 |
Compliance to applicable law and regulation
- The manufacturing license stipulated the Good Gene, Cellular, and Tissue-based Products Manufacturing Practice (GCTP) (Expected to obtain the license in December 2024)
- The license of manufacturing specific processed cells stipulated the Act on the Safety of Regenerative Medicine (Received in July 2024)
- Comply with Standards of Reliability of Application Documents