Ms. Gilmore has 25 years’ experience advising clients on FDA regulatory compliance and policy, life science corporate transactions and business matters. She has counseled clients in every stage of the product and company life cycle in a broad range of industries including medical device and diagnostics, drugs, retail and compounding pharmacies, dietary supplements, food and beverage (including medical/functional foods), CBD and cannabis, tobacco and vapor, cosmetics and aesthetics, health and wellness, and veterinary products. Prior to practicing law, Ms. Gilmore was a Management Consultant whose engagements spanned multiple consumer product industries.

Ms. Gilmore’s goal is to facilitate regulatory activities that are both effective and efficient by providing business-minded legal guidance and insight, strategic analysis and value enhancement. She advises clients regularly on the federal Food, Drug & Cosmetic Act as well as on FDA policy, industry guidance and enforcement priorities. Additionally, Ms. Gilmore is recognized as a leading authority on 510(k) substantial equivalence, the de novo and PMA pathways, DSHEA, the Compounding Quality Act;, the advertising and marketing of FDA-regulated products, off-label and scientific exchange policies, and the regulation of innovative products. She also monitors key evolving issues and has spoken internationally on FDA policy and compliance.