Kimberly Hoefling, MS

Principal Consultant

Kim is an experienced regulatory affairs professional who provides strategic consulting services to the healthcare industry. Her experience includes developing strategic product development plans and providing regulatory guidance, business process improvement, and compliance management services for all types of regulated healthcare products. Kim’s expertise is in guiding companies through the U.S. and international regulatory processes and in preparing regulatory submissions to support clinical testing and product approval. She also assists companies in ensuring that clinical studies are conducted in compliance with appropriate quality systems. Kim has a M.S. in Physiology and Biophysics from Georgetown University and a B.S. in Biology from Boston College. She is a member of the Regulatory Affairs Professional Society (RAPS) and the Drug Information Association (DIA).