About Us
Dr. Koepke's Curriculum Vitae
Dr. Steven Koepke (president and founder) was originally trained as a physical organic chemist, spent 12 years with the National Cancer Institute at the Frederick Cancer Research Facility (NCI-FCRF) as a researcher and progressed into the regulatory world first at the Environmental Protection Agency and later at the Food and Drug Administration.
Dr. Koepke's experience in the chemical and biological work at the NCI-FCRF well prepared him to enter the federal regulatory world. During his tenure at FDA as first a reviewing chemist in the Division of Oncology and Pulmonary Drug Products and later as the Deputy Director of the Division of New Drug Chemistry II, Dr. Koepke gained invaluable insight into the workings of the FDA, the industry's perspective on drug development and regulatory affairs.
In order to provide more comprehensive combination products services, Dr. Koepke has affiliated with CardioMed Device Consultants, LLC, a renowned medical device firm.