Paul Sudhakar

Regulatory Counsel

Paul T. Sudhakar, MS, MBA is the President and CEO of PTS Consulting, LLC and has over 30 years of experience in the pharmaceutical and related industries. Paul has been actively involved in product development activities including broad range regulatory support activities consisting of but not limited to, preclinical, clinical, bioequivalence studies, chemistry & manufacturing controls and filing/approval of drug applications. He is involved in FDA review management of drug and biologic and device applications and regulatory/approval/launch activities for numerous products some of which require circumventing of patents and exclusivities. Paul held leadership positions at Midland Pharmaceutical, ratiopharm GmbH (now Teva), Martec Scientific (now Nostrum Lab) and Martec Pharmaceutical. Managed inception to commercialization (marketing and sales) of various products and filed numerous ANDA products and obtained approvals for several these products with significant brand sales in the US and European market. Paul hold a B.S. and M.S. in Pharmacy from the University Department of Chemical Technology, India, an M.B.A. from Andrews University, Michigan and Kansas State University, Kansas.