Areas of Expertise:USFDA, CFDA, PIC/s, EU GMP, GxP and ISO Compliance,Quality Assurance and Risk Assessment in Pharmaceuticals and Medical Devices,Compliance Auditing and Gap Analysis,GxP Training,Project,Management,Technology,Transfer,Product,Development,and,Commercialisation,Validation,Supply Chain Management,Medical Devices – ISO13485 and 21 CFR Part 820.