Min Xia, Ph.D. in Chemistry. 26 years of experience in pharmaceutical industry. Extensive knowledge and expertise in analytical method development, quality control, regulatory Affairs CMC and regulatory submissions that support across various drug development stages, clinical phases (phase 1 through phase 3) as well as commercial launches. Familiar with GMP/GLP regulations and various FDA and ICH guidelines and requirements. Successful track record of leading analytical labs to pass FDA inspections with zero 483 observations.