On Nov. 20, 2019, SAFE Preclinical Safety Evaluation Center obtained all 9 GLP certifications from the National Medical Products Administration’s (NMPA) .
The experts from Food and Drug Inspection Center of NMPA conduct systemic GLP inspection of GUOKE SAFE Hebei Pharmaceutical Technology Co., Ltd in the last October. The organization, personnel, facilities, quality assurance system and subjects running were rigorously reviewed, and the GLP system and standardized management were highly recognized.
The 9 certifications obtained:
Single and repeated dose toxicity (Rodent animals)
Single and repeated dose toxicity (non-rodent animals, including non-human primates)
Reproductive toxicity (paragraph I and II)
Genetic toxicity (Ames test, Micronucleus test, Chromosomal aberration test)
What is Good Laboratory Practice Certification？
Good Laboratory Practice（commonly abbreviated as “GLP”）Certification is issued by NMPA to Drug Preclinical Safety Evaluation Research Institute to certify the organization, personnel, facilities, Instrumentations, equipment, experimental materials and the implementation of research work of the Institute meet the requirement of Good Laboratory Practice.
GUOKE SAFE Hebei Pharmaceutical Technology Co., Ltd
GUOKE SAFE Hebei Pharmaceutical Technology Co., Ltd was founded in 2017 and put into trial operation in July 2018, 7500 square meters of functional laboratory and laboratory animal feeding facilities have been built in accordance with the most advanced division control concept in the world. We mainly engaged in the non clinical safety evaluation of drugs (biotechnology drugs, chemical drugs and traditional Chinese Medicine), medical devices, food and chemicals under GLP conditions, as well as the pharmacological, pharmacodynamic and pharmacokinetic studies complying with GLP. According to the GLP specifications of NMPA, OECD and FDA, we can conduct a complete set of non clinical safety evaluation studies on dozens of drugs or medical devices at the same time. The center has a number of drug evaluation experts, GLP inspection experts and medical device evaluation experts, and the core technical staff have successfully completed about 1200 pharmacological efficacy and toxicology evaluation experiments at home and abroad, all of which have passed the NMPA or FDA review.
SAFE Pharmaceutical Group
SAFE Pharmaceutical Group is committed to become a world-class one-stop pharmaceutical CRO service company, which consists of pharmaceutical R & D consulting, pharmacological, pharmacodynamic, drug metabolism analysis, pharmaceutical preparations, toxicology and safety evaluation, biological sample analysis and testing, consistency evaluation of generic drug , clinical phase I and post market re-evaluation etc., which can provide one-stop professional service for pharmaceutical R & D companies. SAFE has won the national high-tech enterprises, Beijing Science and technology SMEs, Zhongguancun high-tech enterprises and many other honorary titles. SAFE Pharmaceutical group has pharmaceutical GLP center of Jingnan Gu'an, Shenzhen Chengyao evaluation center, Beijing physical and chemical testing center and clinical evaluation center, Benxi small molecule biological analysis center, drug testing and analysis laboratory jointly built with Shandong University and GCP clinical experiment base of four top three hospitals.
Address：801, Xijin Building, 39 Lianhuachi East Road, Haidian District, Beijing