Regulation Expert Witnesses in Pennsylvania

A 17-year veteran of the U.S. Food and Drug Administration (FDA), this expert served as the Regulatory Counsel to the Associate Commissioner for Regulatory Affairs, and previously, in scientific, inspectional, compliance and criminal and civil enforcement capacities as an FDA Consumer Safety Officer (CSO), Compliance Officer (CO), a Senior Special Agent (SA) with the Office of Criminal Investigations (OCI) and as an analytical regulatory microbiologist. During his last three years at FDA he spearheaded the agency's integration efforts with Customs and USDA on crosscutting interagency enforcement and operational issues; served as the FDA's point-person in managing the intersection of imports and FDA's new bioterrorism regulations; established joint agency and industry working groups to evaluate counterfeiting and tampering risks to food and drug distribution supply chains; was the agency lead in its strategic planning efforts to reinvent the FDA's import programs; wrote the initial statement of work and acted as program manager over the FDA's new PREDICT, risk-based electronic entry screening system; and directed the development of the FDA's agency-wide Risk-based Import Strategic Plan designed to improve compliance of foods, dietary supplements, drugs, medical devices, cosmetics, and biological products imported into the U.S. As CEO of a FDA consulting firm and Founder of an affiliated law firm, he currently represents domestic and foreign companies of all sizes, assisting them in identifying USDA, FDA, Federal Trade Commission (FTC), Environmental Protection Agency (EPA), and state requirements. He focuses his practice on FDA matters, including but not limited to: matters relating to FDA inspections, FDA criminal, regulatory and administrative enforcement actions for medical devices, drugs, cosmetics, alcohol, tobacco, dietary supplements, and foods.

This banking and regulatory expert is currently a Partner in the New York Office of a global law firm. He has over 45 years of industry experience, including 30 years at the Federal Reserve Bank of New York serving as General Counsel, Chief Operating Officer and First Vice President. In that capacity, he served as an alternate member of the Federal Open Market Committee and as a staff member of the President's Working Group on Financial Markets. The expert left the Fed in 1998 to become General Counsel at AIG, a position he held from 1998 until 2006. He has a B.A. in Economics from the University of Massachusetts and a J.D. from Cornell University Law School.

This experienced cosmetics ingredients expert joined Estee Lauder in 1981 as a QA Products Laboratory Supervisor. He remained with the company until 2006, most recently serving as the Director of Special Analytical Services and R&D. In this position, the expert was responsible for Estee Lauder's raw material program, which included oversight of analytical testing, evaluation of new raw materials, and troubleshooting formulation issues. The expert now works as a Product Steward for a personal care ingredients manufacturer, where he deals with R&D, regulatory evaluation, and technical services. He has a B.Sc. in Chemistry from the University of Vermont and an M.Sc. in Chemistry from Adelphi University.

This highly-qualified expert has extensive experience with DEA suspicious order monitoring, as well as opioid and other controlled substance regulations. He earned his BS from Great Lakes University and his MS from Everest University, where he graduated summa cum laude. He is a member of the National Association of Drug Diversion Investigators and the International Health Facility Diversion Association. He formerly served as a state trooper in the Alaska Department of Public Safety and a member of the narcotics detective federal task force at Rapides Parish Sheriff's Office. He later worked as a chief health and safety investigator at MAI LLC, a physical security contractor at the US Department of Homeland Security, and the director of regulatory compliance at Miami-Luken. He is currently a president and CEO at a private consulting company in OH.