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The Center for Drug Safety Evaluation and Research (CDSER) is an organization offering non-clinical safety evaluation services, including but not limited to single- and repeated-dose toxicology, safety pharmacology and genetic studies. Equipped with validated IS/IT facility and electronic data collection system, Provantis, all in-life, clinical pathological data could be collected on-line.

Besides facility to house rodents and canine, CDSER has more than 2000 non-human primate rooms. To date, CDSER has been Good Laboratory Practice (GLP) certified by the Chinese Food and Drug Administration (CFDA) in 2004 and passed the re-inspections in 2008 and 2012, respectively. In March 2012, CDSER got accreditation for compliance with OECD (Organization for Economic Co-operation and Development) GLP guidelines. Moreover CDSER received and successfully passed study-based inspection by British Medicines and Healthcare Products Regulatory Agency (MHRA) in 2013.

 

 

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