Drug Safety Evaluation Basic Information
We boast professional teams and practical experience in drug safety evaluation and can promise high-quality data and fast turnaround time to support various drug safety evaluation. Our toxicology research is carried out using different animals, from dose design, experimental research to histological and pathological research (including clinical detection). The research can be carried out according to non-GLP or GLP standards. Our research platform has been rated as Shanghai R&D Public Service Platform.
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Sino-foreign joint ventureIn 2008, Shanghai Medicilon Inc. and MPI Research (an American CRO specializing in non-clinical drug safety evaluation services) established a joint venture - Medicilon Preclinical Research. As part of the joint venture, MPI provided the American GLP system and standard operation procedures for research to Medicilon Preclinical Research. Scientists from MPI provided training sessions for Medicilon Preclinical Research employees, and completed many non-clinical drug evaluation research projects with Medicilon scientists and technicians for clients at home and abroad.
As GLP-based laboratories are important for non-clinical drug researches, Medicilon Preclinical Research became one of the early CRO companies that built preclinical animal laboratories in China after following their American peers’ experience. The joint venture has been granted AAALAC Accreditation and GLP certification by NMPA, and meets the FDA’s GLP standards . Medicilon Preclinical Research is qualified for IND services and has been granted AAALAC Accreditation.
GLP certificate
AAALAC
Animal roomsMedicilon Preclinical Research has rooms for the following animals:
Mice/rats: 13,000Rabbits: 400Guinea pigs: 400Non-human primates: 550Dogs: 700Miniature pigs: 100
Platform construction
Completed projectsSince 2012, Medicilon Preclinical Research has completed over 30 outsourcing services for non-clinical drug safety evaluation and 800 toxicological services. The tests involve micromolecule drugs, bio-tech-based drugs, vaccines (monovalent and multivalent), Chinese medicines, and natural medicines.
Filing of new drugsSince 2012, Medicilon Preclinical Research has finished nearly 50 complete sets of application materials, as well as hundreds of individual toxicological cases for non-clinical safety evaluation outsourcing services. The data has been reported to the NMPA, FDA, and TGA for IND filing.
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