About Us
Vicky Stoakes, President, has over 30 years combined consulting, FDA, and industry experience, including hands-on execution of laboratory responsibilities.
Vicky has been a consultant to FDA regulated industry since 2002. In this capacity, she has performed cGMP and Mock Pre-Approval Inspections of international and domestic firms and identified critical and major deficiencies. Her responsibilities have included management and coordination of extensive consulting projects to assure the quality work products and timely completion of requested services. She has assisted in guiding and developing Corrective Action Plans, Validation Plans, formal responses and correspondence with FDA, and procedures that comply with FDA expectations. She has also presented formal and informal training seminars covering FDA expectations on a variety of topics.
Previously, Vicky was employed by the U.S. Food and Drug Administration where she served as a Chemist and later as an Investigator for the Atlanta District Drug Cadre. In both roles, she conducted numerous cGMP and NDA/ANDA Pre-Approval Inspections at major pharmaceutical facilities, including compliance audits of Active Pharmaceutical Ingredients and major dosage forms. As the Acting NDA/ANDA Pre-Approval Manager for the Atlanta District Office, she facilitated high priority Pre-Approval assignments, performed technical review of applications, and provided assessment of pending NDAs/ANDAs. Vicky prepared industry seminars, meetings, and conferences addressing regulatory compliance issues and addressed pharmaceutical management on topics of mutual concern. She trained other FDA Investigators, Analysts, and Regional employees in the procedures and methods of evaluating compliance during drug inspections to ensure consistency with Agency policy.
Vicky began her career in the pharmaceutical industry with Merck & Company, where she provided technical support for the production of Active Pharmaceutical Ingredients (APIs) in accordance with cGMP requirements. Her responsibilities included performing multi-step organic synthesis, purification, and isolation of process optimization experiments, use tests, and front runs, and subsequently evaluating compliance to yield and quality specifications. She also resolved manufacturing abnormalities, provided analytical support to assist the achievement of production goals and to aid process changes, and validated analytical methods. Vicky holds a Bachelor of Science in Chemistry.