Dr Kenneth V Phelps has 44 years’ experience in the pharmaceutical industry, including basic drug discovery, drug metabolism, analytical method development, quality assurance, quality control production technology and troubleshooting, regulatory registrations and information systems development. He has management experience in both large and small pharmaceutical companies. He has experience in NDA and ANDA development, preparation and regulatory processes, including electronic submissions. Experience in leveraging pharmaceutical and clinical science into sales and marketing of drug products. Experience in the development of physician and academic thought leaders for both opinions and post-marketing studies. Experience in design and analysis of replicate bioequivalence/bioavailability studies. Expertise in the validation of computer systems, analytical methods and drug production processes. Dr Phelps has solid computer skills including software selection, training and network design.