Regulatory Affairs Consultant

Ann Hards received her PhD in Biophysics and Genetics from the University of Colorado in 1985. She has been involved in drug development since 1990, primarily strategizing and negotiating new drug approval in the employ of large pharma. During this period, she has had the responsibility for the worldwide (US, EU and +/- Japan) submission and prosecution of 6 new molecular entities and 7 major efficacy supplements resulting in 13 approvals. Included among these approvals are products with maximum annual sales of over 30 billion dollars including Lipitor®, Plavix®, Avapro®, etc. Dr Hards is currently working in the development of innovative biotechnology products including her consulting with Moleac