The Drug Safety Evaluation Research Center of Shandong Xinbo Drug R&D Co., Ltd., on July 24, 2024, obtained the new version of the drug GLP certification (Certificate Number GLP021010200) issued by the State Drug Administration.

Introduction to the Non Clinical Safety Evaluation Service Capability of Shandong Xinbo Pharmaceutical Research Co., Ltd
Shandong Xinbo Pharmaceutical Research Co., Ltd. (hereinafter referred to as the "Company") strictly follows the GLP regulations of the National Medical Products Administration (NMPA) of China and the Food and Drug Administration (FDA) of the United States, and can provide the following non clinical safety evaluation services:
Single and repeated dose toxicity tests (rodent and non rodent)
Reproductive toxicity test (Stage I, II, III)
Genetic toxicity tests (Ames test, micronucleus test, chromosomal aberration test, mouse lymphoma test)
Local toxicity test
Immunogenicity test
Safety pharmacology experiments
Toxicokinetics test

The company focuses on providing non clinical commissioned research services that meet international standards for domestic and foreign pharmaceutical companies and pharmaceutical research and development institutions. Since its establishment in 2010, it has provided over 10000 non clinical research services to more than 540 pharmaceutical companies, new drug research institutions, and research institutes both domestically and internationally.
In the field of innovative drugs, the company has completed nearly 400 non clinical evaluation studies of innovative drugs in accordance with domestic and foreign regulatory requirements, covering small molecule compounds, biomolecules, new preventive and therapeutic vaccines, traditional Chinese medicine and other fields. In recent years, we have also accumulated rich non clinical evaluation practical experience in cutting-edge fields such as therapeutic vaccines, cell therapy products, and gene therapy drugs. In addition, the company has completed nearly 4000 generic drug evaluations (by variety).
In terms of facilities and equipment, the company has built a pharmacology and toxicology research laboratory with a total area of over 16000 square meters, which meets international standards, and is equipped with more than 800 sets of various instruments and equipment, providing solid support for high-quality non clinical research.

The company continues to innovate and practice breakthrough barriers to establish a special platform

Prevention and treatment of vaccine safety evaluation platform
Safety Evaluation Platform of Biological Medicine
Anti -tumor drug safety evaluation platform

Cell therapy product safety evaluation platform

Pediatric drug safety evaluation platform

Medical Devices Safety Evaluation Platform