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Keep improving Xinbo safety review

Shandong Xinbo Pharmaceutical Research Co., Ltd. is a scientific research service-oriented enterprise integrating pharmacodynamics research, toxicology research, drug analysis and testing services, animal pathology testing, and medical device evaluation services. It is a high-tech enterprise, Shandong Enterprise Technology Center, and Shandong Gazelle Enterprise.



The company is located in the Beijing Tianjin Hebei Shandong economic zone, and has established a test base in Linyi Economic Development Zone, Dezhou City, known as "Jiuda Tianqu" and "Shenjing Portal". At present, more than 16000 square meters of pharmacology and toxicology research laboratories in line with international standards have been built, and more than 800 advanced instruments and equipment at home and abroad have been equipped. Among them, the toxicology research laboratory can carry out nine studies, including single dose toxicity test, repeated dose toxicity test, safety pharmacology test, reproductive toxicity test, genetic toxicity test, local toxicity test, immunogenicity test, toxicokinetics test and carcinogenesis test, according to the GLP standards of NMPA and FDA.



The company is based on providing high-quality commissioned research services for new drugs and medical research and development institutions. Since its establishment in 2010, it has provided more than 10000 services for 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 international laws and regulations, we have completed the pre clinical evaluation services for nearly 400 innovative drugs, including small molecule drugs, biomacromolecule drugs, new preventive and therapeutic vaccines, and traditional Chinese medicine/natural drugs, helped R&D units obtain more than 50 clinical approval documents for new drugs, and especially accumulated rich experience in the evaluation of therapeutic vaccines, cell and gene therapy drugs that have developed rapidly in recent years. The evaluation of nearly 4000 varieties of generic drugs was completed.



In addition, the company has constantly innovated its practices and broken through barriers, improved and explored the difficult administration technology for young animals, continuous intravenous administration technology, tracheal administration technology and other fields, and has successfully applied them to safety evaluation. The company also pays attention to the demand for innovative development of the global pharmaceutical industry. Based on the key link of innovative drug research and development, and relying on the experience accumulated in serving the domestic and foreign pharmaceutical industry, the company provides the global pharmaceutical industry with comprehensive pre clinical research and development services for new drugs.

  • 14+year
    New drug evaluation experience
  • 540+family
    Serving customers
  • 400+Item
    Preclinical evaluation experience of innovative drugs
  • 4000+Item
    Preclinical evaluation experience of generic drugs
Deadline:2023-12-31

History

2010
2010
Company site
2012
2012
Obtain GLP certification approval
2015
2015
GLP review, add carcinogenic test approval
2018
2018
GLP review
2021
2021
GLP review
2022
2022
Establishment of Medical Device Evaluation Research Center
Facility expansion
2024
2024
Site selection and establishment of Jinan headquarters
May 2024 GLP review

Vision

Innovate and break through, keep improving, and build a well-known CRO enterprise that is first-class in China and in line with international standards

Mission

Service innovation drug research, benefit human health

Values

Quality first, integrity first, rigorous and standardized, precise service

Honors

Partners(Only some cooperative enterprises are displayed)

Yichang Humanwell Pharmaceutical Co., Ltd

Yichang Humanwell Pharmaceutical Co., Ltd

Tianjin Hankang Pharmaceutical Biotechnology Co., Ltd

Tianjin Hankang Pharmaceutical Biotechnology Co., Ltd

Changchun Baike Biotechnology Co., Ltd

Changchun Baike Biotechnology Co., Ltd

Changchun Biological Products Research Institute Co., Ltd

Changchun Biological Products Research Institute Co., Ltd

Shiyao Group

Shiyao Group

Qilu Pharmaceutical Co., Ltd

Qilu Pharmaceutical Co., Ltd

Beijing Xiantong International Pharmaceutical Technology Co., Ltd

Beijing Xiantong International Pharmaceutical Technology Co., Ltd

PLA Academy of Military Science

PLA Academy of Military Science

Shandong University

Shandong University

Kelun Pharmaceutical

Kelun Pharmaceutical

Shandong Luoxin Pharmaceutical Group Co., Ltd

Shandong Luoxin Pharmaceutical Group Co., Ltd

Sinopharm

Sinopharm

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