Congratulations to Guorui Yinuotong on obtaining the national veterinary drug GCP certification!
Release time:
2023-12-29 09:40
Keywords:
Agriculture,Veterinary medicine,Livestock
2023 Year 12 Moon 26 On [date], the Animal Husbandry and Veterinary Bureau of the Ministry of Agriculture and Rural Affairs issued a notice stating that Xixian New Area Guorui Yinuo Drug Safety Evaluation and Research Co., Ltd. has passed the supervisory inspection of the Good Clinical Practice for Veterinary Drugs conducted by the expert panel, and its trial projects meet the requirements of the Good Clinical Practice for Veterinary Drugs.
The trial projects submitted by Guorui Yinuo this time include: field trials for efficacy evaluation of pet medications, bioequivalence studies for pet medications, pharmacokinetic studies for pet medications, and safety studies on target animals for pet medications.
The “Good Clinical Practice Guidelines for Veterinary Drug Trials” were originally issued by the former Ministry of Agriculture. 2015 Year 12 The monthly release aims to strengthen the management of veterinary drug clinical trials, improve trial quality, and ensure that veterinary drugs are safe, effective, and of controllable quality. The guidelines stipulate that veterinary drug clinical trials must adhere to scientific, ethical, and legal principles, protect the welfare and safety of experimental animals, and safeguard human health and environmental safety. The implementation of these guidelines will help enhance the quality and reliability of veterinary drug clinical trials, promote veterinary drug research and development and innovation, and ensure animal health and public health security.
Guo Rui Yinuo has previously obtained approval from the National Medical Products Administration for its drug. GLP Certificate, Veterinary Drugs from the Ministry of Agriculture and Rural Affairs of China GLP Certification, National Accreditation Commission CNAS GLP Certificate.
Guo Rui Yinuo’s building area reaches 6400 Square meters, Phase I investment 3000 Over several hundred thousand yuan, the facility is now equipped with a liquid chromatography-mass spectrometry system, a high-performance liquid chromatograph, a fully automatic chemiluminescence analyzer, an animal blood analyzer, an automated tissue dehydrator, a pathology diagnostic microscopy system, a microscale laboratory balance, an animal oral and nasal inhalation exposure system, and a UV-Vis spectrophotometer, among other instruments. 300 We have a comprehensive suite of instruments and equipment, and have established experimental platforms covering genetic toxicology, reproductive toxicology, analytical testing, 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 clinical trial sample analysis. We also provide services for the safety evaluation of veterinary drugs, food products, health supplements, and cosmetics. In addition, our company has set up platforms for the development of disease model animals and the breeding of laboratory animals. We have assembled a stable, experienced, and highly qualified professional team, and have established systems that comply with U.S. standards. FDA 、 OECD And China NMPA Regulatory requirements GLP System.
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