Compliance Architects® was founded by Jack Garvey, a leading expert-attorney in FDA-regulated compliance, quality, operations and regulatory matters. Jack possesses close to 30 years of hands-on leadership experience at top-performing life science companies including Johnson & Johnson, C.R. Bard, Ciba-Geigy, BASF Corporation and Ayerst Laboratories. Using both traditional and proprietary approaches to quality and compliance remediation, Jack expands upon traditional operational practices with pragmatic solutions that can reduce enforcement risk from today’s aggressive FDA. A chemical engineer and attorney by formal training, Jack possesses the legal, regulatory and process expertise that allows him to excel at the complex interplay of science, law and business.
Through regular blogging, webinars, presentations and public speaking, Jack is known for his savvy, no-nonsense approach to FDA compliance and his ability to resolve the most complicated compliance and enforcement issues facing FDA-regulated industry, rooted in the belief that FDA enforcement risk can be mitigated – with hard work, sufficient investment and innovative approaches.