Kathleen is the Founder and Managing Partner of ProPharmaCon, LLC, a life science consulting practice to the pharmaceutical, OTC, device and cosmetic industries. Before founding ProPharmaCon in 2001, Kathleen held many Regulatory and Quality positions at multiple companies. She has led the regulatory strategies for the submission of various INDs, NDAs, ANDAs, and has expertise in the regulatory aspects of developing drug delivery systems. In her consulting capacity, Kathleen assists companies with strategic regulatory guidance, advertising and promotional reviews, regulatory and quality systems, as well as due diligence activities. She has been part of several market launch teams for products in various therapeutic areas, and with her in-depth knowledge and understanding of the regulatory environment, helps numerous companies with promotional strategies, review of materials, and risk assessment.
Kathleen earned a B.S. in Chemistry from Fairfield University and an MBA from the University of New Haven.