Shandong Xinbo Drug Safety Evaluation Research Center
2024/10/23
The company is located in the Beijing Tianjin Hebei Shandong economic zone, and has established a pilot base in the Linyi Economic Development Zone of Dezhou City, known as the "Nine Dash Tianqu" and "Gateway to Shenjing". At present, more than 16000 square meters of pharmacology and toxicology research laboratories that meet international standards have been built, equipped with more than 800 advanced instruments and equipment at home and abroad. Among them, the toxicology research laboratory can conduct 9 studies including single dose toxicity tests, repeated dose toxicity tests, safety pharmacology tests, reproductive toxicity tests, genetic toxicity tests, local toxicity tests, immunogenicity tests, toxicokinetics tests, and carcinogenicity tests in accordance with the GLP standards of NMPA and FDA.
The company is committed to providing high-quality commissioned research services for new drug and medical research and development institutions. Since its establishment in 2010, it has provided over 10000 services to more than 540 pharmaceutical companies, new drug research institutions, and research institutes both domestically and internationally. We have completed preclinical evaluation services for nearly 400 innovative drugs in accordance with domestic and foreign regulatory requirements, including small molecule drugs, biomacromolecule drugs, new preventive and therapeutic vaccines, and traditional Chinese medicine/natural medicine evaluation work. In particular, we have accumulated rich experience in the evaluation of rapidly developing therapeutic vaccines, cell and gene therapy drugs in recent years. Completed the evaluation of nearly 4000 varieties of generic drugs.
In addition, the company continuously innovates its practices and breaks through barriers, improving and exploring difficult areas such as administration technology for young animals, continuous intravenous administration technology, and tracheal administration technology, and maturely applying them to safety evaluation. The company also pays attention to the demand for innovative development in the global pharmaceutical industry, focusing on the key link of innovative drug research and development. With the accumulated experience in serving the domestic and international pharmaceutical industry, it provides comprehensive preclinical research and development services for new drugs in the global pharmaceutical industry.
Service Items
■ Single dose toxicity test
■ Repeated administration toxicity test
■ Safety pharmacology testing
■ Reproductive toxicity test
■ Genetic toxicity test
■ Carcinogenic test
■ Immunogenicity test
■ Local toxicity test
■ Pharmacodynamic experiments
■ Research on Safety Evaluation of Medical Devices
■ Other experiments (monkey neurotoxicity test/abnormal toxicity/tumorigenicity test/tumorigenicity test/soft agar test)
Test substance management system
The independently developed and designed test substance management system has achieved the electronicization of the process of receiving, collecting, archiving, and disposing of test substances.