Guorui Yinuo successfully passed the NMPA drug GLP renewal and new application inspections.
Release time:
2024-08-02 20:26
Keywords:
Clinical,Medication
According to the "Drug Administration Law of the People's Republic of China" and the "Administrative Measures for the Certification of Good Laboratory Practice for Non-Clinical Drug Studies," This year 04 Moon 22 day ~ 26 Day, National Medical Products Administration (NMPA) NMPA ) Organization GLP The inspection expert group and its members 5 People, regarding Xixian New Area Guorui Yinuo Drug Safety Evaluation and Research Co., Ltd. (hereinafter referred to as “ Guo Rui's Promise ” ) was conducted for a duration of 5 Medicine of the sky GLP Regular inspections and inspection applications for additional items.
The inspection experts reviewed Guorui Yinuo’s quality assurance system, Standard Operating Procedure A detailed verification was conducted on the management of all aspects, including the document system, staffing and research capabilities, facility environment, equipment configuration, computerized systems, test articles, and archives. In addition, the relevant research data were rigorously reviewed.
Recently, Guo Rui's Promise Received NMPA Notice on the Results of the Regular Inspection of the Quality Management Standards for Non-Clinical Drug Studies, as well as the Drugs for Which Additional Items Have Been Applied. GLP The certification approval, notice, and approval document state that: Guo Rui's Promise Compliant Good Practice for Quality Management of Non-Clinical Drug Studies Requirements Currently, Guo Rui Yi Nuo. Original Qualification and newly applied-for projects Coverage “ Single-dose and repeated-dose toxicity studies (rodents); single-dose and repeated-dose toxicity studies (non-rodents) , does not contain primates ) 、 Genotoxicity test ( Ames micronucleus assay, chromosomal aberration assay), local toxicity tests (allergic reactions, irritation, hemolytic activity), and toxicokinetic studies. ” Five Major research project. 
Xixian New Area Guorui Yinuo Drug Safety Evaluation and Research Co., Ltd. was established 2018 Year 11 Yue is an independent, third-party drug safety evaluation research institution located in the Free Trade Pilot Zone of Konggang New City. Guorui Yinuo... 2021 Year 07 The drug has been approved by the National Medical Products Administration. GLP (Certification under the Good Laboratory Practice for Non-Clinical Drug Studies), becoming the first in the province to pass the national drug certification. GLP A certified non-clinical safety research institution has filled a gap in our province. GLP The laboratory’s capabilities will establish a convenient, efficient, and reliable technical platform for new drug research and preclinical safety evaluation in Shaanxi Province’s pharmaceutical industry, playing a crucial role in further enhancing Shaanxi Province’s drug R&D level, its independent innovation capacity in the pharmaceutical sector, and the quality of drug research. As an important intermediate link in the transformation of innovative drugs from the innovation chain to the industrial chain, drug safety evaluation research serves as the bridge that connects these two stages. “ Qin Chuangyuan ” The interactive integration of the innovation chain and the industrial chain in the life sciences sector holds significant value for the development of the province’s life science industry. Currently, Guorui Yinuo has obtained approval from the Ministry of Agriculture and Rural Affairs of China for veterinary drugs. GLP 、 GCP Inspection passed by the China National Accreditation Service for Conformity Assessment. CNAS GLP Certification.
Guo Rui Yi Nuo has been... Xi'an Municipal Bureau of Industry and Information Technology Recognized as 2022 The innovative small and medium-sized enterprises in Shaanxi Province have been recognized by the Xi'an Science and Technology Bureau. 2022 Xi'an City of the Year “ Drug Non-Clinical Safety Evaluation Research Platform ” The Engineering and Technology Research Center has been recognized by the Xi'an Science and Technology Bureau as... 2023 Year “ Xi'an's New R&D Institutions ” , recognized by the Shaanxi Provincial Department of Science and Technology as 2024 Year “ Shaanxi Province’s New R&D Institutions ”。 Guo Rui's Promise Currently, there are high-level talents (local leading talents) in Xi'an City. 2 Name: Xixian New Area Qin Chuangyuan Innovation Talent Program - High-end innovation team 1 Zhī, Shaanxi Provincial Department of Science and Technology, Qin Chuang Yuan “ scientist + Engineer ” Team 1 Support. 
Guorei Yinuo integrates drug toxicology, pathology, pharmacology, analytical testing, cosmetics, and generic drug consistency evaluation services into a single platform, possessing tremendous growth potential. The company’s building area reaches... 6400 Square meters, Phase I investment 3000 Over 100,000 yuan—currently equipped with a liquid chromatography-mass spectrometry system, high-performance liquid chromatograph, fully automatic chemiluminescence analyzer, animal blood analyzer, automated tissue dehydrator, millionth-of-a-gram balance, animal oral and nasal inhalation exposure system, UV-visible spectrophotometer, and fluorescence microscope, among others. 300 We have a comprehensive suite of instruments and equipment, and have established experimental platforms covering genetic toxicology, analytical testing, reproductive toxicology, and clinical pathology. Our company is dedicated to non-clinical safety evaluation of drugs, offering clients a one-stop service that includes personalized protocol design, drug screening, pharmacodynamic studies, pharmacokinetic studies, safety assessments, and analysis of clinical trial samples. We also provide services for safety evaluations of food, health supplements, chemicals, and cosmetics. In addition, our company has established capabilities in the development of disease-model animals and the breeding of laboratory animals. nurture and other platforms. Our company has assembled a stable, experienced, and professional team and has established systems that simultaneously comply with U.S. regulations. FDA 、 OECD And China NMPA Regulatory requirements GLP System.
In the future, Guorui Yinuo will continue to strengthen institutional development and management, strictly adhering to... GLP We are committed to conducting non-clinical safety evaluations of pharmaceuticals, effectively helping companies shorten the new drug development cycle and enabling faster, safer access to the market! Guo Rui Yinuo will always uphold the philosophy of “human health and environmental safety,” providing high-quality services to customers worldwide. 
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Ms. Li:+86 15760970681
Mr. Su:+86 19991001701
Landline:+86-29-33656828
Company Address
4th Floor, Unit C. Building 9. Small and Medium-sized
Enterprise Park, Airport Industrial Zone Airport New Ciy,Xixian New Area, Shaanxi Province
©2026 Xixian New Area Guorui Yinuo Drug Safety Evaluation and Research Co., Ltd.
WhatsApp：8613940397353
Email：hr-xian@grglp.com
Landline：862933656828
Mr. Su：8619991001701
Ms. Li：8615760970681