Asebey Life Science – FDA regulatory law firm

Asebey Life Science Law is a boutique FDA regulatory law firm specializing in FDA regulatory compliance, transactional law, and advisory services for the life sciences industry. At our firm, we leverage our experience as scientists and attorneys to deliver unparalleled legal services to domestic and global clients.

Founded by Edgar J. Asebey, a seasoned FDA regulatory attorney with over 25 years of regulatory law experience, we are uniquely positioned to offer comprehensive legal solutions informed by a deep understanding of science and regulatory frameworks.

With expertise spanning pharmaceuticals, biotechnology, medical devices, food, dietary supplements, cannabis, hemp, and psychedelics, we provide innovative strategies and expert counsel to enable our clients to thrive in a complex and rapidly changing regulatory environment.

Our Professionals

Edgar J. Asebey, Esq.

Managing Partner

See full bio

Guilherme Ferrari Faviero, M.S., MPH

Research Associate

See full bio

At Asebey Life Science Law, we integrate scientific knowledge and regulatory expertise to provide clients with cutting-edge guidance and comprehensive legal solutions.

Technical Advisors

Over the past two decades, our attorneys have worked with a variety of highly skilled technical advisors throughout the U.S., Europe, Latin America, India, China and Japan. Depending on your company’s needs and geographic location, we are able to bring technical expertise to assist on any matter. These technical experts include:

Ph.D. food scientist to support design of testing protocol for a New Dietary Ingredient Notification (NDIN) submission
Ph.D. toxicologist to assist in designing preclinical trials
Ph.D. toxicologist to perform biocompatibility testing in support of a 510(k) submission
Certified GMP inspectors in Japan, India, Colombia, Spain and the U.S.
Ph.D. natural product scientist to assist client in designing proprietary beverage
Technical/scientific consultancy to determine physical/chemical properties of an alleged adulterant found in a cosmetic product in support of a Prop 65 defense.
Engineering consultant to support creation of design controls for a 510(k) submission
Ph.D. polymer scientist to support creation of technical dossier for a novel food contact material
Various former FDA officials for technical advisory services in the areas of foods, medical devices, in vitro diagnostics and dietary supplements, among others.

Co-Counsel

As a life sciences boutique law firm, Asebey Life Science Law works hand-in-hand with lawyers and law firms requiring our firm’s specialized regulatory capabilities. We have served as co-counsel on matters such as:

Support corporate law firm by performing regulatory due diligence in support of a potential acquisition of a food technology company
Support litigation law firm in preparing Lanham Act unfair competition litigation against a medical device company
Support patent law firm by providing FDA regulatory support for medical device client
Provide FDA regulatory guidance to Brazilian law firm seeking to facilitate medical device’s entry into the U.S. market
Support German law firm with regard to import compliance for Class I and Class II medical devices
Support law firm litigating hemp agricultural contract dispute with expert advisory service