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Preclinical Clinical trial Related services Registration and Regulations
 
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Preclinical research laboratories are located in Exton,Pennsylvania, US and Shanghai, China. Both of the two laboratories follow the same SOP quality system, easy for method transfer and data reporting, these labs have passed repeatedly audit checks by the US FDA, China CFDA and WHO organization.


Services Scope

Preclinical research/DMPK

Bioanalysis
Pharmacokinetics PK/PE
Bio/immunoassay

Biomarker analysis

 

CMC Services

GMP API manufacture/organic synthesis of reference standards
Pharmaceutical product formulation development
GMP clinical materials manufacturing – non-sterile and sterile forms

GMP analytical services, including method development and validation

 

CMC Laboratory
25,000-square feet of CMC analysis laboratory and GMP formulation laboratory are located in Exton City
30,000-square-foot CMC laboratory is located in Suzhou City Jiangsu Province