• GUANG GAO
  • Principle Consultant
  • Axteria Biomed Consulting Inc.

Curriculum Vitae

Education

Ph.D. in Biochemistry, Nanjing University, China 1988
M.S in Biochemistry, Nanjing University, China 1985
B.S.in Biochemistry, Nanjing university, China, 1982

Professional Experience

• Extensive FDA regulatory experience (inspectional, compliance, and regulation) in GMP from compliance /regulatory perspectives
• Working experience on drug and device product development and approval strategies
• Substantive working knowledge of FDA regulatory requirements for drugs and medical devices; preparation and responding to Warning Letters and Inspectional Observations; preparation for Regulatory Meetings; responding various kinds of FDA review letters
• Extensive knowledge and experiences in Chinese pharmaceutical industry
• Fully understanding of Chinese regulatory system for drug/biologics/medical device
• Working experience of WHO Prequalification program

Research Interests

N/A

Honors & Awards

• Scientific Achievement Award - Regulatory Scientists, CBER, 2013
• CBER Group Award, 2013
• Commissioner’s Special Citation, 2015

Publications