ABOUT

ORIGINS

Pharmacy Law Counsel was founded in 2008 as compounding began its exponential growth into the consumer health care market. We are here to ensure that every pharmacy of every size has access to FDA subject matter expertise.. 

A decade later, FDARC is still the original and premier specialty regulatory, scientific, and compoudning legal boutique. We understand the Agency's policies and procedures and have the resources to assist.

WHY PLC

PLC provides FDA guidance and representation at the moment a pharmacy needs it. Whether subject to an inspection or recall, working to comply with FDA requirements in everyday operations, or conducting transactional due diligence, PLC is there. We count among our clients large and small 503As and 503Bs in need of additional expertise.

With advanced degrees and decades of experience, our team has the insight necessary to handle complex regulatory and compounding issues.

OUR TEAM
Melissa Gilmore JD
Managing Partner

mgilmore@fdarc.com | 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, and cosmetics 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 and investors. 

 

Additionally, Ms. Gilmore is recognized as a leading authority on the 503B Compounding Quality Act, and was called upon to educate legislators on Capitol Hill during its drafting.

 

Ms. Gilmore is a graduate of Duke University and Georgetown Law School. She is an active member of the life sciences community and speaks internationally on FDA regulatory compliance.

Donato J. Borrillo MD JD MS
Partner

dborrillo@fdarc.com | 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.   

More details? Contact us

Schedule a courtesy consultation online, or email or call to find out how insight reduces risk and increases return.

 

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1717 K St., NW

Suite 900

Washington, DC 20006

202.465.8669 o

202.714.0856 m

200 East Randolph St.

Suite 5100

Chicago, IL 60601

312.485.7276 o

419.466.5512 m

PHARMACY LAW COUNSEL

Regulatory Means Business.

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© 2018 by Pharmacy Law Counsel LLP

DISCLAIMER

This site is not intended to be legal advice. Contacting the firm or reading the materials on the site does not create an attorney-client relationship. No confidential information should be sent over the internet. Past results do not predict future outcomes as each situation has to stand on its own. Melissa Gilmore is licensed to practice law in the District of Columbia, New York (inactive), and California (inactive). Donato J. Borrillo is licensed to practice law in Ohio.