Edgar Asebey-Birkholm is partner and FDA practice group manager at Roetzel & Andress, a legal firm with 200 attorneys and 13 offices located throughout Ohio, Florida, Chicago, New York and Washington, D.C. He provides counsel to clients on compliance, registration, importation and enforcement matters related to FDA-regulated products. Asebey-Birkholm also assists domestic and foreign clients in registration, clearance and pre-market approval submissions to the FDA, and advises clients on compliance issues associated with labeling and advertising, the manufacturing process and other regulatory issues associated with the development, manufacture, marketing and sale of FDA-regulated products.
