Accumulated experience and this guy to also assist with making sure FDA filings are done correctly:
WILLIAM SCOTT GRONER Quality & Regulatory Affairs Consultant
Scott Groner is Vice President of Quality & Regulatory Affairs at Elite. Scott brings more than 30 years of regulatory and quality experience in both the pharmaceutical brand and generic industry and includes extensive knowledge in regulations, quality systems, assessments, FDA submissions, compliance, and product applications for both oral solid dosages and sterile and non-sterile liquid products. In addition to six years of consulting in the pharmaceutical industry, Scott’s experience includes positions at Duramed, Pfizer, Schering-Plough and Warner Lambert. Scott received a Bachelor of Science in Chemistry from Western New England College.