Chongqing Gerui Clinical Research Center Co., Ltd
Established in September 2015, located in Chongqing International Biological City, Chongqing Liujiang Pharma Technology Co., Ltd owns CRO platform for drug development, clinical phase I management and bioassay; in 2016, it was awarded “New Enterprise R&D Organization” by Chongqing Economic and Information Commission, and in 2017, it was approved by Chongqing Economic and Information Commission as the first generic drug quality and efficacy consistency evalsuation center in Chongqing. Chongqing Liujiang Pharma introduced AI technology and applied the drug R&D intelligent system to the process of experimental protocol design, reaction condition control and experimental data analysis. The Company focuses on the development and production transfer of generic drugs and also carries out the development of modified new drugs.
Since its inception, the Company has established a team consisting of highly skilled and experienced experts, led by Dr. Zhang Zongping, a well-known expert in the field of bioanalysis in the United States. As the project leader, Dr. Zhang Zongping has a distinguished educational background both at home and abroad. He was the director of bioanalysis director and R&D director of multinational pharmaceutical giants GSK and PPD, etc. and has more than 20 years of experience in drug R&D and senior management of world-renowned pharmaceutical companies as well as rich experience in drug bioanalysis research, GLP laboratory management and DMPK R&D.
The Company has more than 130 professional technical and managerial personnel in various fields such as medicinal chemistry, analysis, preparation, biology, registration filing, etc., including 2 returnees and PhDs, nearly 20 people with master’s degree or above, 89% with bachelor’s degree or above, nearly 30 leaders in various disciplines and sub-disciplines. More than 65% of the scientific research personnel have more than 3 years of drug R&D experience, and full-time R&D personnel account for more than 80% of the total number of employees in the Company. At the same time, the Company established a full-time project management QA team to safeguard the R&D work of the platform.
The Company has a pharmacy research platform that covers 11,000 square meters and a GLP bioanalysis laboratory that covers 300 square meters. It has more than 50 laboratories for synthesis, preparation, quality, pharmacology, toxicology and other functions and advanced research instruments and equipment worth more than RMB 50 million. For synthesis, the Company has double-layer glass reactor (30L, 50L), rotary evaporator, and reactor high and low temperature integrated machine, etc. For preparation, the Company has wet type granulator, dry type granulator, grinding and granulate machine, fluidized bed granulator, multi-directional movement mixer, tablet press, coating machine, capsule filling machine, blister packing machine (aluminum-plastic, aluminum-aluminum), automatic sampling and dissolution instrument, airflow pulverizer, Malvern particle size instrument, etc. For chemical and biological analysis, the Company is equipped with HPLC, GC, liquid chromatograph / mass spectrometer, gas chromatograph-mass spectrometer, atomic absorption, preparative liquid phase, semi-preparative liquid phase, ion chromatography, AB triple quadrupole 6500+ mass spectrometer, Shimadzu UPLC LC-30A, temperature controlled centrifuge, vortex oscillator, etc. The configuration of the above advanced instruments and equipment provides a favorable guarantee for excellent quality, high efficiency and quality-controlled drug development.
The Company highly values the establishment and operation of the quality control system and has formulated and issued more than 400 quality management documents and instrument and equipment operating procedures documents, which has basically built an international standard and domestic first-class quality control system. In addition to strengthening the establishment of the management system, the Company has also launched the Beta network training system, carried out a full set of standardized operating procedures for employees by means of online and offline forms to ensure that the management system is effective and effectively improves the professionalism of R&D personnel.
In terms of laboratory management, the Company has enabled a part of intelligent facilities and equipment, including bioanalysis LIMS management system, refrigerator temperature monitoring system, private cloud terminal sharing system and other professional network management system, to provide technical guarantee for scientific, standardized and process-oriented experimental management, analysis cost saving, work efficiency improvement, and real, effective and traceable test data.