(301) 260-2200 dhai@msn.com
Don Hill & Associates, Inc., 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).
Don Hill and his select cadre of qualified associates 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 and more recently in traditional small molecule drugs. This experience includes:
• Recognized worldwide for expertise in evaluation of manufacturing facility design, validation and process operations;
• Performing cGMP audits of API, clinical manufacturing and fill/finish facilities, manufacturing operations, quality systems and documentation;
• Preparing clients for pre-approval, biennial and "for cause" cGMP inspections;
• Providing technical assistance in the development and manufacture of monoclonal antibodies, vaccines, chemical synthesis and polymer products;
• Assessment of the potential regulatory risks inherent in the manufacturing process, the scientific rationale for the development program and the strength of the validation approach. Providing alternatives for mitigating risk;
• Design and implementation of Quality systems for the development and manufacture of biologics and pharmaceuticals;
• Substantial experience in the development and implementation of successful regulatory CMC strategies to ensure IND and CTA acceptance for conduct of early phase through late phase clinical trials and product registration;
• Review and/or prepare CMC filings for regulatory submissions such as IND, CTA, BLA, NDA, MAA Master Files;
• Review and/or prepare Quality agreements for contract manufacture;
• Review and/or prepare Briefing Documents by establishing agendas and content for meetings with regulators;
• Write/edit/review responses to regulatory agency inspection observations and regulatory questions or requests;
• Providing training tailored to your company needs on compliance to regulatory agency cGMPs, regulations, facility requirements, quality systems, validation of manufacturing facilities, equipment cleaning and environmental monitoring.
