- Counsel to foreign and domestic manufacturing facilities regarding FDA inspections, regulatory meetings, warning letters, import alerts, and consent decrees. This work has included extended on-site support in India, Central Europe, and China.
- Counsel to multinational clients on risk assessment and control strategies for nitrosamine and other genotoxic impurities. This work has included preparing submissions to regulatory authorities, working with experts in analytical chemistry, cleaning validation, and toxicology, on long term remediations, and preparing executive managers for meetings with regulatory authorities focused on nitrosamine impurities.
- Advising and counseling domestic and foreign pharmaceutical manufacturers on issues related to data integrity.
- Advising foreign and domestic pharmaceutical manufacturers on the implications of FDA inspection delays.
- Counsel to blood banks and other clients regarding blood product regulatory compliance matters.
- Counseled on pharmacy compounding and outsourcing facility issues.
- Counseled on new drug applications for marketed unapproved products.
- Negotiated the successful resolution of import alerts and warning letters related to CGMPs, data integrity, and inspection refusal.
- Negotiated an FDA consent decree in a case involving the mass seizure of a generic drug company’s inventory.
- Served as the defense team’s first chair for expert testimony on CGMPs and analytical method validation in United States v. Barr Laboratories, widely recognized as the leading case on CGMPs.