Donghao (Robert) Lu, Ph.D.
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• US FDA Senior CMC Reviewer (10 years)
• Fellow of American Association of Pharmaceutical Scientists (AAPS) (since 2007)
• Full Professor of Pharmaceutics at Temple University
• Associate Professor of Pharmaceutics at University of Georgia
• PhD in Industrial and Physical Pharmacy from Purdue University
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 with China and US pharmaceutical companies,
for their regulatory and CMC development and submissions (Phase 1-2-3, NDA) on small molecules, as well as botanical drug products.
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Feiwen Mao, M.S.
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• United States Pharmacopeia (USP), senior DS/DP monograph reviewer/writer (15 years), Understanding well in FDA Regulatory
• Worked in USA Johnson & Johnson and other companies as senior analytical/QA manager (10 years)
• M.S. in Industrial and Physical Pharmacy from Purdue University (1990)
Feiwen Mao is an eCTD expert and a Regulatory and CMC consultant (Principal Consultant,
Reg-Strategy Consulting, LLC, USA).
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