Edgar J. Asebey is a life sciences regulatory and transactional attorney with over 20 years of experience advising clients in the pharmaceutical, biotechnology, biologics, medical device, food, dietary supplement, cannabis and psychedelic drug development industries on FDA regulatory compliance, licensing, transactional and venture finance matters. Edgar represents clients before the U.S. Food and Drug Agency (FDA), United States Department of Agriculture (USDA), U.S. Customs and Border Protection (CBP), U.S. Federal Trade Commission (FTC), the U. S. Environmental Protection Agency (EPA) and the National Institute for Occupational Safety & Health (NIOSH), providing compliance and enforcement defense services before those agencies. He assists client companies in registration, clearance, and pre-market approval applications to the FDA and advises clients on compliance issues associated with the development, manufacture, marketing, and sale of FDA-regulated products.
He counsels clients and preforms regulatory due diligence in support of venture financings, public offerings and M&A transactions. He also advises emerging life science and psychedelic drug development companies on patent portfolio development, FDA and clinical trial strategy. Since 2015, he has been advising cannabis companies and today provides regulatory compliance, due diligence and transactional services to hemp/CBD, cannabis/marijuana and psychedelic drug discovery companies. In addition to his law practice, Edgar is a founding member and the FDA regulatory advisor of the lter Investments Fund, a venture capital firm focused on supporting emerging psychedelic drug discovery companies.
Early in his career, Edgar served as Patent and Licensing Advisor to the Natural Products Branch of the National Cancer (NCI) at the National Institutes of Health (NIH). He founded and served as president of Andes Pharmaceuticals, Inc., a natural products drug discovery company, from 1995 to 2000 and has served as in-house counsel to two life sciences companies. Most recently he was an equity partner in the Health Care & Life Sciences Practice Group at Jones Day and later served as founding partner at Keller Asebey Life Science Law, PLLC. Throughout his career, Edgar has published 62 articles, reports, book chapters and books and has presented at over 70 seminars and conferences throughout the USA, Europe, Latin America, Japan and India. Most recently, he co-authored the authoritative treatise, Legal Guide to the Business of Marijuana (PLI Press, 2021).
Edgar studied molecular biology at the University of Chicago and spent 5 years working in molecular biology research laboratories at The University of Chicago and the University of Illinois School of Medicine. He holds a law degree from Catholic University of America (Washington, D.C.) and is licensed to practice law in Florida and Washington, D.C. He is a member of the American Bar Association, Food & Drug Law Institute (FDLI), Dade County Bar Association, and BioFlorida.
Torrey Pines Law Group, PC serves technology innovators with protecting intellectual property, obtaining regulatory approvals and clearances, and making deals and closing technology transactions throughout the U.S., including in major technology hubs such as San Diego, San Francisco, Palo Alto, San Jose, Silicon Valley, Boston, Cambridge, Chicago, Minneapolis, Houston, Dallas, Atlanta, Denver, Seattle, Portland, Boulder, Orlando, the Research Triangle (Raleigh, Durham, and Chapel Hill), the Mid-Atlantic (New Jersey, New York, Philadelphia, Maryland, Virginia, and Washington, DC), Pittsburgh, Cleveland, Ann Arbor, and throughout Southern California in Los Angeles, Orange County, Irvine, Torrey Pines, Sorrento Valley, and La Jolla.
We have experience with international intellectual property, regulatory and transactional matters pending in Beijing, Shanghai, Shenzhen, and Guangzhou China; Tokyo, Japan; Berlin, Munich and Frankfurt Germany; Tel Aviv Israel; Mumbai, Bengaluru, and New Delhi India; London and Edinburgh United Kingdom; Vancouver, Toronto, Calgary and Montreal Canada; Dublin, Ireland; Cape Town, South Africa; Mexico City and Tijuana Mexico; Brussels, Belgium; Copenhagen, Denmark; Paris, France; Madrid and Barcelona Spain; Moscow, Russia; Santiago, Chile; Montevideo, Uruguay; Buenos Aires, Argentina; Sao Paulo and Rio de Janeiro Brazil; Seoul, South Korea; Taipei, Taiwan; Hong Kong; Hanoi, Vietnam; Bangkok, Thailand; Kuala Lumpur, Malaysia; Milan, Italy; Singapore; Sydney, Melbourne, Perth and Adelaide Australia; Auckland, New Zealand; Oslo, Norway; Stockholm, Sweden; Helsinki, Finland; Kiev, Ukraine; Budapest, Hungary; Vienna, Austria; Prague, Czechia; Geneva and Lausanne Switzerland; Bahrain; Doha, Qatar; Abu Dhabi and Dubai UAE; and Jeddah, Saudi Arabia.
US FDA Regulatory Attorney - FDA Regulatory Legal Opinions - FDA Regulatory Due Diligence - FDA Regulatory Compliance