Philip K. Burns
Mr. Burns has more than 25 years experience in the senior Pharmaceutical Operations environment including site organizational design, management, and product introductions, and Quality Compliance /Technical Production experience including cGMP compliance, Quality Assurance and Compliance, and Regulatory Affairs. He has overseen retooling and reformulation of products produced on the billion-pill scale to building manufacturing facilities for liquids, emulsions and powder/capsules.
Michael A. Gill
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.
Jeff Staffa, PhD
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.