FDA Regulatory Counsel was founded in 2008 on the progressive idea that every stakeholder in the life science industry should have access to FDA subject matter expertise. Because the pool of experienced counsel is shallow, and the regulated footprint broad, there is great efficiency to plugging in knowledge on demand.
A decade later, FDARC is still the original and premier specialty regulatory boutique. We understand the Agency's policies and procedures and have the resources to assist.
FDARC provides on-demand life science expertise in corporate transactional, regulatory, litigation and government advocacy settings. We count among our clients respected teams nationwide who seamlessly expand their capabilities when needed.
With advanced degrees and decades of experience, our team has the insight necessary to handle complex regulatory issues.
Melissa Gilmore JD
| Direct: 202.714.0856
Ms. Gilmore has over 20 years’ experience practicing FDA regulatory law in Washington, ultimately rising to lead the FDA Practice Group of an AmLaw 100 firm. She has advised and consulted with device, drug, dietary supplement, pharmacy, cosmetics, tobacco and hemp/cannabis clients of all sizes and stages and in all aspects of FDA compliance. Ms. Gilmore is the national go-to subject matter expert for an extended network of law firms, lenders, investors and regulated entities.
Additionally, Ms. Gilmore is recognized as a leading authority on substantial equivalence, off-label communications, the Deeming Rule (e-cigarettes/vaping) and currently-evolving FDA regulation including cannabis and CBD. She has been called upon to educate regulators and legislators on those and other forefront issues of their time, including the 503B Compounding Quality Act and Dietary Supplement Health and Safety Act.
Ms. Gilmore is a graduate of Duke University and Georgetown Law School, and is currently completing a MA program at Harvard University. She is an active member of the life sciences community and speaks internationally on FDA regulatory compliance.
Donato J. Borrillo MD JD MS
| Direct: 419.466.5512
Dr. Borrillo is a practicing physician, attorney, scientist, pilot, and decorated war veteran. He is also a sought-after national legal expert in healthcare and life science matters, and advises on transactional diligence for FDA-regulated companies and products. Dr. Borrillo's ability to provide subject matter insight is unmatched.