* Master of Pharmacy and PhD in Natural Sciences specialized in pharmaceutical biology
* Over 30 years experience in all fields of drug development with special emphasis on regulatory affairs with FDA and EMEA, the leading Health Authorities worldwide
* Specialized in the development and registration of NCEs, mainly bio-tech compounds
* Track record of successful approvals of many submitted NDAs including three Roche blockbusters (Rocephin®, Roferon® (Interferon) and Neupogen®)
* As independent consultant for the past 11 years advised and assisted several companies in the development and regulatory strategies for successful approval of their ERT products in LSDs