Prabu Nambiar

Prabu Nambiar, Ph.D., M.B.A., R.A.C., Syner-G Pharma Consulting, LLC, CMC Consultant. Dr. Nambiar 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 held previous positions as Vice President of Regulatory Affairs CMC at Vertex Pharmaceuticals and Senior Director, CMC Regulatory Affairs at Cubist Pharmaceuticals. He has led the filing and approval of 11 NDAs, numerous sNDAs, INDs and international filings. Dr. Nambiar and the Syner-G team is overseeing CMC management for teixobactin.