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Bioanalytical department has strong technology, regulatory knowledge and rich experiences in the industry, can provide methods to verify compliance with US GLP regulations and sample analysis from the early to late-stage clinical development studies.

Team technical staff have extensive experience in GLP laboratory work, among which there are about 45 people in the US laboratory and 20 in Shanghai laboratory; more than 70 percent hold master’s degree or above; most of our team members have 5 years of work experience or more; senior management team is stable, with project leaders have mostly served this company for more than 5 years.


Bioanalytical Labs for Small and Large Molecules

Method development, transfer and validation
Sample analysis
Clinical biomarker and immunogenicity
Biomarker assay development and validation

Pharmacokinetic/pharmacodynamic evaluations

 

Laboratory

22,000square feet ofbioanalyticallaboratoryis one of thelargest of its kindlaboratoriesin the eastern US.

16,000 square feet, one of China s largest laboratories of its kind in Shanghai (GLP standards)