Edgar Asebey

Edgar Asebey has extensive experience in government regulation of pharmaceutical, biotechnology, medical device, food, dietary supplement, and cosmetics companies. He counsels clients on complex regulatory strategies and product approval/clearance matters and represents clients before the FDA, FTC, USDA, and EPA. He has managed pharmaceutical, medical device, and food product recalls and regularly provides enforcement defense services to life science companies. Edgar counsels clients and performs regulatory due diligence in support of financings, public offerings, and M&A transactions. He also advises telemedicine and health IT companies on the intricacies of FDA regulation of Medical Device Data Systems (MDDS), mobile medical apps, and clinical decision support (CDS) software.

Edgar assists clients in the preparation of FDA submissions, including NDAs, ANDAs, and 510(k) premarket notifications and is considered an expert on implementation and compliance with the Food Safety Modernization Act (FSMA). [1]