Michael Wu
Regulatory Head

Michael Wu

Michael has more than 11 years of regulatory affairs experience in pharmaceutical industry. He has proven record of successful import and local pharmaceuticals registration and Comprehensive knowledge of NMPA(NMPA)/CDE requirements, policies and processes CTA, IMCT, NDA, Variation, Renewal, QC testing, CDE consulting meetings. Through the years, Michael filed over 30 CTA and IMCT, 6 NDA, 80 renewal and arranged over 20 CDE/NMPA meetings.