Feng Feng, Secretary of the Party Leadership Group and Director of the Provincial Drug Administration, along with his delegation, visited Guorui Yinuo to inspect the progress of the safety assessment laboratory’s construction.
Release time:
2023-12-11 10:13
Keywords:
Medicine,Supervision
On December 7, Feng Feng, Party Secretary and Director of the Shaanxi Provincial Drug Administration, along with his delegation, visited Xixian New Area Guorui Yinuo Drug Safety Evaluation and Research Co., Ltd. to learn about the construction status of the drug GLP safety evaluation laboratory. Chen Mai, Chairman of Guorui Yinuo, and Su Lai, General Manager, warmly welcomed the delegation and provided a detailed report on the construction progress of the safety evaluation laboratory.
The research team conducted on-site inspections of Guorui Yinuo’s Reproductive Toxicology Laboratory, Genetic Toxicology Laboratory, Archives Room, Clinical Testing Laboratory, Pathology Technology Room, DSA Operating Room, and other facilities. They also listened to a briefing from the company’s senior management on the expansion of the drug GLP safety assessment laboratory’s accreditation and its technical service offerings.
Feng Feng emphasized that non-clinical safety evaluation studies of drugs are a series of toxicological tests conducted under laboratory conditions to assess the safety of pharmaceuticals. When conducting such non-clinical safety evaluation studies, researchers must strictly adhere to unified standards and procedures to ensure the authenticity, accuracy, and completeness of research data, thereby guaranteeing the reliability and reproducibility of study results. Feng Feng urged Guorui Yinuo to rigorously comply with relevant laws and regulations, including the "Good Laboratory Practice for Non-Clinical Studies" and the "Key Inspection Points and Judgment Principles for the Quality Management of Non-Clinical Studies," and to pay close attention to and meticulously manage all aspects of enterprise management—from organizational structure and personnel, quality assurance, facilities, experimental systems, instruments and equipment, experimental materials, test articles and reference standards, standard operating procedures (SOPs), implementation of research activities, documentation and archiving, to computerized systems—so as to deeply develop GLP technical services and, in turn, drive high-quality development of drug R&D in our province and promote independent innovation in the pharmaceutical industry. Feng Feng expressed his hope that Guorui Yinuo would accelerate the expansion of its GLP qualifications across all relevant areas and strive to obtain early bilateral accreditation from the international FDA and OECD.
Guo Rui Yinuo covers a building area of 6,400 square meters, with Phase I investment exceeding 30 million yuan. It is now equipped with... We are equipped with over 300 pieces of instrumentation, including liquid chromatography-mass spectrometry systems, high-performance liquid chromatographs, fully automated chemiluminescence immunoassay analyzers, animal blood analyzers, automatic tissue dehydrators, pathology diagnostic microscopy systems, microbalance scales for laboratory use, animal oral and nasal inhalation exposure systems, UV-Vis spectrophotometers, and more. We have established comprehensive experimental platforms covering genetic toxicology, reproductive toxicology, analytical testing, and clinical pathology. Our company is dedicated to non-clinical safety evaluation of pharmaceuticals, 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 safety evaluations of food products, health supplements, cosmetics, and medical devices. In addition, our company has developed platforms for the creation of disease model animals and the breeding of laboratory animals. We have assembled a stable, highly experienced team of professionals and have established a GLP-compliant system that meets the regulatory requirements of the U.S. FDA, OECD, and China’s NMPA.
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