Robert_ Lee Kram MD MSE

Lee Kramm MD, MSE

Founder, President/Chief Strategist and Medical Officer

Lee Kramm is a Board-certified ophthalmologist and regulatory professional with 5 years of experience as a medical officer and senior reviewer at the Division of Ophthalmic, Neurological and ENT Devices (DONED) at FDA. As part of ClinReg Consulting Services for 8 years, he provided client services as a senior regulatory consultant for devices, biologics, and drug products. Dr. Kramm has reviewed and prepared clinical trial plans, classification opinion memos, de novo applications, pre-submissions, IDE’s, IND’s, PMA’s, 510(k)’s, HUD’s, NDA’s and requests for designation (RFD’s). Services also include standing as official correspondent for communications between clients and regulatory bodies.