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.
Binesh Prabhakar, MBA
At Syner-G, Binesh leads business strategy and operations. He has more than twelve years of experience in Life Sciences, mainly supporting IT functions including Compliance, Auditing, and Validation. In addition to Syner-G, Binesh is a Partner at Cambridge IT Compliance, an IT organization supporting Life Sciences.
Binesh received his Bachelor of Science in Engineering from St. Joseph’s College of Engineering (affiliated to the University of Madras, India); his Masters of Science in Environmental Science from Texas A&M University-Corpus Christi, Texas, and his Masters of Business Administration from Babson College, Massachusetts. Outside of work, Binesh plays cricket for United Athletic Association Cricket Club, affiliated to Massachusetts State Cricket League.