Don Hill & Associates Our company , founded in 1990, provides consulting services to the biotechnology, biologics, and pharmaceutical industry. The company is comprised of former FDA officials and pharmaceutical industry personnel, all with hands-on experience in interpreting and applying cGMPs and regulatory requirements. Our clients include major multi-national pharmaceutical companies, start up operations and clinical manufacturing, virtual companies and contract manufacturing organizations (CMO). We bring many years of FDA regulatory and quality assurance experience to help you achieve your objectives and needs for biotechnology products, vaccines, cellular and gene therapy products.