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Good News | Shandong Xinbo Safety Assessment Center GLP Certification Approval Document Old Certificate Renewed Certificate

2024/08/12

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.

At present, Shandong Xinbo can be carried out in accordance with the GLP requirements of NMPA and FDA:
Single and repetitive drug toxic test (rodent)
Single and repeated drug toxic test (non -rodent)
Reproductive toxicity test (section I, section II, III section)

 Genetic toxicity test (AMES, Microuctuctuary, chromosome distortion, mouse lymphoma test)

Local toxicity test

Immunogenic test

Safety Pharmaceutical Test

Poison Dynamics Test

The company is based on providing high -quality commissioned research services to new drugs and medical research and development institutions.

         Since its establishment in 2010, it has provided more than 10,000 services to more than 540 pharmaceutical companies, new drug research and development institutions and scientific research institutes at home and abroad. In accordance with the requirements of domestic and foreign regulations, more than 400 clinical evaluation services for innovative drugs are completed, including small molecular drugs, biomarbon drugs, new prevention and therapeutic vaccines, and Chinese medicine evaluation work, especially in recent years, the rapid development of therapeutic vaccine, The evaluation of cells and gene therapy has also accumulated rich experience. Complete the evaluation of more than 4,000 varieties.

Shandong Xinbo has built more than 16,000 square meters of pharmacological and toxicology research laboratories that meet international standards, equipped with more than 800 advanced instruments at home and abroad.


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


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