President And Ceo
CurrentHands-on support on matters pertaining to Quality Management Systems and cGMP Regulatory Compliance for Pharmaceutical and Biopharmaceutical companies. Led the start-up of a regulatory compliance consulting firm on a foundation of long-term business associations with an array of pharma companies and professionals covering the full spectrum of pharmaceutical development and commercial manufacturing. Initial client engagements include:• Creation and rollout of a Quality Management System for a virtual company preparing for its first commercial launch.• Remediation of critical supplier manufacturing and control issues identified by a regulatory agency inspector to minimize sponsor company product impact risk.