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Shenzhen InnoStar Biomedical Safety Evaluation Research Institute Co., Ltd. Passes the Certification of NMPA GLP
2023-04-12

Shenzhen InnoStar Biomedical Safety Evaluation and Research Institute Co., Ltd. has successfully received the good laboratory practice (GLP) certification for conducting non-clinical studies from the National Medical Products Administration and become the first GLP-certified CRO company in Shenzhen.

 

According to Chinese regulations, the preclinical safety evaluation studies of new drugs must be conducted in GLP-certified laboratories. This GLP certification signifies that Shenzhen InnoStar has become a national first-class company for its drug non-clinical safety evaluation research level in terms of organization management and personnel, instruments, equipment and experimental materials, standard operating procedures and study performance, and will continue to contribute to the global development of biomedical companies in the Greater Bay Area.

 

Shenzhen InnoStar Biomedical Safety Evaluation and Research Institute Co., Ltd. is an international first-class biomedical safety evaluation service platform jointly built in Shenzhen by the Shanghai InnoStar Bio-tech Co., Ltd., Shenzhen Institute for Drug Control and Shenzhen Nanshan SEI Investment Co., Ltd. Since its opening at the end of 2020, Shenzhen Innostar has established and improved its quality management requirements, and consolidated operation foundation in virtue of rich experience of InnoStar's Shanghai headquarters in GLP laboratory practices. This GLP inspection covered the development of quality system elements such as organization structure and personnel files, instrument and equipment validation, test articles and controls, SOP system, experiment performance, facility environment and arrangement. The inspection team conducted a detailed review and inquiry on the above contents through on-site inspection and information review and highly recognized the company's organizational management, technique level and dedication.

 

Shenzhen InnoStar owns more than 10,000 square meters of laboratory facilities, in which non-clinical safety evaluation can be performed simultaneously for 15 drugs. Shenzhen InnoStar is capable to provide services on non-clinical safety evaluation, non-clinical pharmacokinetics and non-clinical druggability assessment, etc.

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