Ken Phelps

Ken Phelps applied more than three decades of industry experience to found Camargo Pharmaceutical Services in 2003. As an expert in drug development and the industry authority on development via the 505(b)(2) regulatory approval pathway, Phelps leads the team that has guided hundreds of FDA approvals. Camargo now has the largest percentage of 505(b)(2) submissions of any team submitting to the U.S. Food and Drug Administration (FDA). Before founding Camargo, Phelps’ diverse background in drug development had led to a number of executive-level assignments in the areas of quality control, project management and regulatory, clinical and medical affairs at Duramed Pharmaceuticals. Phelps also held a number of positions at Merrell-National Labs (which merged to become Merrell Dow and later evolved into Aventis), where he was responsible for global quality assurance, quality control and processing technology with an assignment based in Milan, Italy.