Highly respected key opinion leaders
Synedgen science advisors include internationally respected leaders in multiple disciplines including oral and ophthalmic health; gastrointestinal health and antimicrobial resistance; and mucosal infection, radiation and immunology. This team advises appropriate design of drug administration, critiques drug development plans and trial design, and also assesses the potential impact of the drug for strategic partners and investors.
Gill is a skilled Regulatory, QA, QC compliance specialist with an extensive knowledge of quality assurance and quality control systems, document controls and regulatory requirements. He has 27 years of experience in the pharmaceutical industry with extensive knowledge of managing US FDA, EU and German regulatory authority inspections for US manufacturing facilities, and provides a full service of regulatory and compliance consultation for the pharmaceutical industry, including regulatory, cGMP, cGLP, and cGCP compliance.
Jeffrey A. Staffa has had extensive experience in all aspects of the pharmaceutical industry spanning a career of over 30 years. He has worked for the U.S. FDA, a small privately held company, a small publicly held company, a large publicly held company, and the largest chemical company in the world. He has worked and participated in regulatory affairs, x-ray crystallography, medicinal and agricultural chemical synthesis, pilot plant manufacturing, quality control, safety surveillance, preclinical toxicological evaluation, pharmacokinetics, clinical pharmacology, and clinical development. He has served as the scientific advisor to attorneys working for the federal government and for numerous companies. He has advised Commissioners of the FDA and prepared FDA General Counsel for hearings and trials. He is fluent in the business aspects of the pharmaceutical industry. He has worked with biologics, drugs, devices, foods, and veterinary products.