Lee Mia Nagao, Ph.D . is a Science Advisor in the Health Practice Group, and is a member of the firm's Pharmaceutical and Medical Device Team. Lee advises domestic and international clients in the areas of testing and regulation of device components, pharmaceutical development and manufacturing, auditing, current Good Manufacturing Practices (cGMPs) and drug master files and other regulatory submissions. Lee's expertise also includes the development of methods and standards requirements for drug products. She represents industry groups before the FDA and other regulatory and scientific agencies in the United States and Europe. |