Edgar J. Asebey is a partner at Keller Asebey Life Science Law, PLLC and brings over 2 decades of experience in government regulation of pharma, biotech, med device, food, dietary supplement and cosmetics companies. With experience within government, as in-house counsel and as a CEO of a life science company, he brings a wealth of knowledge to clients who require novel solutions to complex issues, such as clients in the hemp/CBD and cannabis/THC sectors.Mr. Asebey's experience includes counseling clients on complex regulatory strategies and product approval/clearance matters as well as representing clients before the FDA, FTC, USDA and EPA. He has managed pharma, med device and food product recalls and regularly provides enforcement defense services to food, CBD and life science companies. Mr. Asebey counsels clients and performs regulatory due diligence in support of financings, public offerings and M&A transactions. He advises stem cell and regenerative medicine companies and has also advised 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. Most recently, he has advised companies in the CBD (hemp) and THC (marijuana) space with regard to State and Federal regulatory compliance, advertising and labeling compliance and has led numerous negotiations in support of corporate transactions.Mr. Asebey assists clients in the preparation of FDA submissions, including NDAs, ANDAs 510(k) premarket notifications and NDIs and has in-depth knowledge on implementation of and compliance with the Food Safety Modernization Act (FSMA). He has advised the governments of Colombia and Japan on FDA regulatory compliance matters and has led FDA regulatory seminars in Osaka, Nagoya, Tokyo, Bogota, Cali, Medellin and Barranquilla. He currently serves as outside counsel to a medical device and two in vitro diagnostic companies.

Partner specialized in FDA, USDA, EPA and FTC regulatory matters. Provided regulatory guidance to pharmaceutical, medical device, dietary supplement, biologics, cosmetics and food companies. Also provided guidance and enforcement defense services to hemp/CBD and cannabis companies. Assisted clients in preparation for financing, due diligence, M&A and corporate transactional matters.

Edgar Asebey's practice focuses on the areas of food, medical devices, drugs, biologics, dietary supplements, Cannabis (hemp/CBD and THC) and cosmetics. He advises clients in these industries on regulatory, registration, importation, and enforcement matters. He also counsels clients on premarket approval submissions and on compliance issues associated with the development, manufacture, marketing, and sale of FDA-regulated products and provides support in licensing and transactional matters to FDA-regulated companies.Edgar has in-depth experience in the Food Safety Modernization Act (FSMA) and has lectured extensively in more than 30 forums in Latin America, Japan, and the U.S. on FSMA's impact on U.S. importers, non-U.S. food exporters, and food companies. He also has represented numerous foreign food companies before the FDA, including rice, seafood, olive, fish oil, and nut exporters and fresh and processed food manufacturers. In addition, with regard to medical devices, Edgar performs FDA regulatory and CMS reimbursement due diligence on behalf of venture capital firms and private companies prior to investment or M&A activities. He also works with clients on the preparation of various FDA submissions, which include 510(k) premarket notifications, food additive petitions, GRAS self-affirmations and notifications, and product listing registrations. Edgar's experience includes pursuing client interests before the FDA, FTC, USDA, EPA, and state regulatory agencies.Edgar is a member of the American Bar Association (Section on Administrative Law & Regulatory Practice: Food and Drug Committee and International Committee), Food & Drug Law Institute (FDLI), Dade County Bar Association, and BioFlorida.

Edgar Asebey's practice focuses on the areas of food, medical devices, drugs, dietary supplements, and cosmetics. He advises clients in these industries on regulatory, registration, importation, and enforcement matters. He also counsels clients on premarket approval submissions and on compliance issues associated with the development, manufacture, marketing, and sale of FDA-regulated products and provides support in licensing and transactional matters to FDA-regulated companies.Edgar has in-depth experience in the Food Safety Modernization Act (FSMA) and has lectured extensively in more than 30 forums in Latin America, Japan, and the U.S. on FSMA's impact on U.S. importers, non-U.S. food exporters, and food companies. He also has represented numerous foreign food companies before the FDA, including rice, seafood, olive, fish oil, and nut exporters and fresh and processed food manufacturers. In addition, with regard to medical devices, Edgar performs FDA regulatory and CMS reimbursement due diligence on behalf of venture capital firms and private companies prior to investment or M&A activities. He also works with clients on the preparation of various FDA submissions, which include 510(k) premarket notifications, food additive petitions, GRAS self-affirmations and notifications, and product listing registrations. Edgar's experience includes pursuing client interests before the FDA, FTC, USDA, EPA, and state regulatory agencies.Edgar is a member of the American Bar Association (Section on Administrative Law & Regulatory Practice: Food and Drug Committee and International Committee), Food & Drug Law Institute (FDLI), Dade County Bar Association, and BioFlorida.

Practice Areas: FDA registration/compliance for drugs, devices, foods, dietary supplements, biologicals, cosmetics; Intellectual Property(biotech, chemical); Corporate & Transactional (US, Latin America); Customs & International Trade

Practice Areas: FDA / FTC regulatory; Patent (biotech, chemical); Corporate & Transactional (US, Latin America)