Prior to starting his freelance consulting venture Paul was at QuadraMed (and acquired by Fulcrum Pharma) as a Senior Regulatory Affairs Consultant.
Paul provided consultancy and strategic management for regulatory interactions, preparations for regulatory procedures, oral hearings, medical writing and compliance activities in relation to clinical-stage products. This experience also included consulting on the technical and strategic management of biologic CMC plans and deliverables for clinical-stage products. Prior to joining QuadraMed, Paul was at Parexel Consulting Group having previously gathered commercial experience in three global pharmaceutical companies.
Paul Smith received his Bachelor of Science degree in Biological Sciences (Biol Molec, Summa cum Laude) from the University of Edinburgh and completed a PhD in Virology at the National Institute for Medical Research (London). In 2008 Paul was designated CSci as a chartered scientist and a FICR in 2011 by the Institute of Clinical Research.
With years of experience in the pharmaceutical industry Paul is most interested in regulatory strategies for new products, interacting with regulators on the optimum route to marketing authorisation with appropriate licensing conditions.
Some of this work is for new products in the exploratory and/or pivotal stages of clinical development where manufacturing changes are coordinated with increasing clinical supplies and the results-responsive planning of clinical trials.