McCoy Enterprises LLC provides high client value by assembling and providing the required resources to address FDA compliance issues quickly, efficiently, reliably, and sensitively. Our network of resources extends worldwide, from project leaders, mechanical and material engineering experts, analytical chemists, and regulatory specialists, to organizational & logistics personnel, public relations and political allies. The scope and extent of our resource talent is considerable.
We are flexible and tailor our services to complement client requirements and budgets, address specific concerns immediately, and routinely address intense, sustained efforts for short- or long-term programs, both nationally and off-shore.
McCoy Enterprises LLC. is a fast-moving, hands-on manufacturing service firm specializing in the medical device and pharmaceutical manufacturing industries. Although the core firm is relatively small, the division has a worldwide range of resources it calls upon to create the best possible team to solve client problems quickly and efficiently. By keeping overhead costs low and expertise high, we provide high value to our clients. From solving manufacturing problems to ISO 9000 and GMP consulting, to new active substance formulations.
Randall “Randy” McCoy has more than 20 years of experience in scientific research and development. His previous employment includes George Washington University , Temple University Medical School , and RCA/SRI International (Director of Pharmaceutical Projects). Mr. McCoy has assisted both small and major pharmaceutical companies address FDA issues. He has also helped over 225 foreign and domestic companies introduce their drug and medical device products into the US and World market. Mr. McCoy currently has over 30 Patents US and World Wide and a NIH grant pending for a new drug.
Roy Nelson PhD is a specialist in fine particle technology, polymer science and drug chemistry. His previous employments include the USArmy Material Laboratory at Ft. Belvoir, Avery Products Central Research Laboratories, RCA/SRI International’s Sarnoff Laboratories. Dr. Nelson received his B.S. degree in chemistry from UCLA, M.S. in synthetic drug chemistry from the University of Illinois and a Ph.D. in material/polymer science from Penn. State University. His material testing facility has a Schedule I – V Drug License and is FDA audited. He currently has over 25 Patents US and World Wide. He has been involved in a number of validation studies, drug certification, SOP (instruments, processes, IT) writing and other compliance issues.
Randall E. McCoy, President
McCoy Enterprises LLC
10 High Court
Little Falls, NJ 07424
Phone: (646) 403-3581 HQ, (609) 730-0575 business office