Dr. Donghao (Robert) Lu is a drug development expert and a Regulatory and CMC consultant (President and Chief Consultant, Reg-Strategy Consulting, LLC, USA). Currently Dr. Lu carries out his consulting work (%FTE freelance, i.e. part-time employee) with China and US pharmaceutical companies, for their regulatory and CMC development and submissions (Phase 1-2-3, NDA) on small molecules. In addition, since left FDA, he provided regulatory consulting at Parexel International Corp. (USA) and for several famous Chinese pharmaceutical companies (including Chinese medicine); and therefore has significant real-case experience on FDA and CFDA meetings, US/EU and China/APAC regulatory submissions, problem solving strategies, and many other regulatory issues... Prior to joining FDA, Dr. Lu was a full professor in pharmaceutics at Temple University and an associate professor at University of Georgia. Over 15 years as a university professor, he served as major professor for 17 graduate students..