President and Principal Consultant at Biologics Quality & Regulatory Consultants - Gaithersburg, MD, US
Provides Consultation in Development, Manufacture & Regulation of Biological Products in a Dynamic 21st Century Risk-based Regulatory Environment with focus on Total & Sustainable Quality & Compliance based on Science & Law for the International Market, using Modern Concepts of Quality by Design (QbD) & Risk Management Approaches to exceed Minimum Requirements