Pharm.D., JD is the President of Frost Biopharmaceutical Consulting, a consulting firm focused on assisting companies in bringing their drug products to market. We provide services in the areas of overall drug development, regulatory strategy/liaison, clinical development, regulatory affairs submissions including IND's NDA's and REMS, DDMAC, labeling and regulatory compliance. Dr Frost has over 20 years experience in the industry having held positions in Pharmacokinetics, Professional Services/Medical Affairs, Clinical Research, Regulatory Affairs and Quality Assurance/Compliance. He has worked for large Pharma and Biotech as well as small biotechnology companies and is experienced in all aspects of drug development. He has gained approvals for new products in many therapeutic areas in US, Canada, and EU.