Services Overview

FDAmc is the nation’s premiere boutique law firm providing on-demand FDA legal, medical, and scientific consulting services to FDA-regulated businesses, law firms, litigation teams, and lenders and investors in the medical device, drug, pharmacy, dietary supplement, cosmetic, and veterinary products industries.

FOR REGULATED COMPANIES

If your business falls within the FDA’s massive and complex legal footprint, you are already well aware of the burdens put upon industries that operate where innovation and regulation intersect. The FDA has regulatory oversight of 1 in every 4 consumer products sold in the U.S. – from tongue depressors to echocardiograms, lipstick to pet food, and vitamin C to chemotherapy drugs. Additionally, the scope of FDA’s jurisdiction is wide – the Agency controls their development, manufacture, advertising, sales, and follow-up quality control reporting. Moreover, FDA requires most companies involved in marketing regulated products to consumers to register and conform to often-subjective and selectively-enforced regulatory requirements.

FOR PHARMACIES

FDA & Medical Counsel helps its clients understand and comply with pharmaceutical compounding regulatory requirements. While compliance is running smoothly, we work with our clients – in a practical, business-minded manner – to keep it that way. When FDA issues arise, we work on your behalf to minimize negative regulatory enforcement attempts. And all of the time, we provide broad legal support for employing best practices in operating a 503A or 503B pharmacy. Moreover, FDAmc understands that every facility is unique because it must start from where it is; thus, each FDA compliance strategy is tailored to fit.

FOR LAW FIRMS

FDA & Medical Counsel allows firms to capture the FDA compliance expertise of a former AmLaw 100 FDA practice group leader. We take full direction from our client firms, as a member of the team, and on a project basis. Moreover, having spent decades inside large and small law firms, FDAmc is sensitive to the needs of law firm clients with regard to client optics, billing, and other internal matters.

FOR LENDERS/INVESTORS

From broad pre-deal industry questions to granular company due diligence, FDA & Medical Counsel provides business clients with the expertise needed to support informed decisions when crafting deals in FDA-regulated spaces. FDAmc provides companies with a regulatory due diligence checklist to navigate through those environments by assessing compliance, regulatory framework, and business risk and implications.