Andrew Harrison Regulatory Compliance Associates, Inc.

Andrew Harrison is the Chief Regulatory Affairs Officer and General Counsel for Regulatory Compliance Associates (RCA). In addition to his role as our General Counsel, Andrew Harrison brings a core layer of medical device and pharmaceutical expertise to RCA's already diverse slate of professionals. An advocate for sustainable regulatory compliance, he has an unbending desire to assist clients spanning all organizational size or product portfolio complexity. To achieve this, Andrew draws upon his over 15 years of extensive experience in technical quality assurance, compliance, regulatory affairs, government affairs/public policy as well as his legal training to analyze and address key situations impacting FDA-regulated companies. Andrew has also supported clients affected by some of the more esoteric areas in healthcare such as state-based pharmacy practice and wholesale distributor laws and regulations.

Andrew is a frequent speaker at industry conferences and a welcome resource to our clients in need of strong domain support on matters pertaining to regulatory approvals/clearances, clinical trials, advertising & promotion, good manufacturing practices, post-approval requirements, recalls/market withdrawals, audits, inspections, warning letters and enforcement actions, such as injunctions and consent decrees.

A graduate of the John Marshall Law School and the East Tennessee State University in B.Sc., Microbiology.