Kay Mitchen

Background

About Kay Mitchen

Kay Mitchen has more than 30 years of regulatory experience in the FDA regulated industries. Her expertise is in the development and implementation of cGMPs and Quality System Standards applicable to the Drugs, In-Vitro Diagnostics Medical Devices, Cosmetics, Foods and Dietary Supplements industries. As officer for several companies, she successfully developed and maintained Quality System procedures to ensure overall GMP compliance with FDA, and achieve certifications to ISO, NSF and CE Mark among other international standards, as well as international products registrations, opening wide doors of business opportunities at the international level. She successfully hosted over 33 combined audits by the US FDA, Health-Canada, ISO, TUV Europe, NSF and Major clients and investors. She interfered with the US FDA and other State and Federal Agencies for the resolution of companies’ issues with a considerable history of successful problem solving experience. She also managed the development of programs for internal and suppliers’ audits and served as lead auditor for critical and technical areas and suppliers. Kay Mitchen is also the owner of FDA-GMP Consultants, a regulatory consulting firm- With tens of years of successful interactions with regulatory agencies, FDA-GMP Consultants LLC can assist you with your cGMP (Good Manufacturing Practices) needs. Our strength is in GMP audits/gap analysis, and quality system development (SOPs), tailored to the nature of your operations. We work for the Dietary Supplement, Cosmetics, Medical Devices and Pharmaceutical industries. In other words, we are a global consulting firm organized to provide comprehensive Quality System and Compliance services for all FDA-regulated companies. FDA-GMP Consultants also networks with regulatory consulting firms, therefore offering you a one stop shop for all your regulatory compliance needs. Contact Kay, who offers the best regulatory compliance models at minimal costs.