Prabu Nambiar, Ph.D. MBA, RAC
Principal and Founder
Prabu acquired his Ph.D. in Organic Chemistry from Oregon State, completed his post-doctoral training at Brown University and got his Executive MBA from Boston University. He has over 25 years of industry experience including last 20 years in CMC Regulatory Sciences. His extensive CMC experience includes resolution of complex CMC/Quality and Compliance issues (regulatory starting materials, Genotox impurities, specifications, QbD implementation, PAI responses) using science and risk-based approaches and leading NDA/Regulatory Teams. He has worked in various therapeutic areas and on a broad range of dosage forms including immediate and modified release oral products, inhalation products, sterile injectables and drug-device combination products. He has led the filing and approval of 11 NDAs, numerous sNDAs, INDs and international filings. He is a member of RAPS, ACS and AAPS and was the chair of Regulatory Science section at AAPS.