Mike Li, MS
Chemistry, Manufacturing & Controls (CMC)

Mr. Li was graduated from Tunghai University and received the MS degrees in Chemistry and Chemical Engineering.  He has 40 years hands on experience in the development of pharmaceutical products for various dosage forms. He has been involved in preformulation/formulation studies, process development, manufacturing and scale up as well as analytical development such as method development, validation, and stability studies.

Mr. Li has served in management positions in various US pharmaceutical companies.  His last position was Sr. Director of Product Development at Threshold before becoming a full time Chemistry, Manufacturing and Controls (CMC) consultant in 2006.  Up to now, he has been involved development of more than 70 generic injectable drugs, more than 30 INDs and two NDAs.  He also helped 4 companies IPO and many due diligence activities.