Edgar Asebey

Edgar J. Asebey is a life sciences regulatory and transactional attorney with over 20 years of experience advising pharmaceutical, biotechnology, biologics, medical device, food, and dietary supplement companies on FDA compliance and related regulatory matters, including licensing, transactions, and venture finance.

Edgar represents clients before the U.S. Food and Drug Administration (FDA), the United States Department of Agriculture (USDA), U.S. Customs and Border Protection (CBP), the U.S. Federal Trade Commission (FTC), the U.S. Environmental Protection Agency (EPA), the National Institute for Occupational Safety & Health (NIOSH), and the Drug Enforcement Agency (DEA). His work includes providing compliance and enforcement defense services before these agencies. He assists companies with FDA registration, clearance, and pre-market approval, and advises on compliance throughout the development, manufacturing, marketing, and sale of FDA-regulated products.

Edgar also conducts regulatory due diligence to support venture financings, public offerings, and M&A transactions, and advises emerging life sciences and psychedelic drug development companies on patent strategy, FDA regulatory pathways, and clinical trial planning. Since 2016, he has counseled cannabis and hemp businesses, providing regulatory, transactional, and due diligence services to hemp/CBD, cannabis/marijuana, and psychedelics biotechnology companies.

In addition to his legal practice, Edgar is a founding member and the FDA regulatory advisor to the Iter Investments Fund, a venture capital firm focused on supporting emerging psychedelic biotech companies.

Earlier in his career, Edgar was Patent and Licensing Advisor to the Natural Products Branch of the National Cancer Institute (NCI) at the National Institutes of Health (NIH), later founding and leading Andes Pharmaceuticals, Inc., a natural products biotech company. He has served as in-house counsel to two life sciences companies, was an equity partner in a AM 200 law firm’s Health Care & Life Sciences Practice Group, and in 2016 founded Keller Asebey Life Science Law, PLLC, the predecessor to Asebey Life Science Law.

Edgar has an extensive record of thought leadership, with more than 50 published articles, reports, book chapters, and books, and has delivered over 60 presentations at seminars, webinars, and conferences across the U.S., Europe, Latin America, Japan, and India.

Edgar is fluent in Spanish.