(301) 260-2200 dhai@msn.com
Don Hill & Associates, Inc., founded in 1990, provides consulting services to the biotechnology, biologics, and pharmaceutical industry.
Don Hill & Associates, Inc bring many years of FDA regulatory and quality assurance experience to help you achieve your objectives and needs for manufacturing biotechnology products, vaccines, cellular and gene therapy products. This experience includes:
Evaluating design of new and renovated manufacturing facilities for compliance with the cGMP regulations.
Performing cGMP audits of drug substance (API) manufacturing, clinical manufacturing and fill/finish facilities. Our auditing services offer FDA system-based inspections to assess facilities, manufacturing operations, quality systems and documentation.
Conducting mock pre-approval inspection (PAI) audits to identify gaps of non-compliance with the cGMP regulations. We also provide assistance in developing appropriate and reasonable action plans to address the gaps.
Performing third-party audits of contract manufacturers and contract laboratories;
Reviewing/editing clients responses to FDA inspectional observations and compliance letters, CMC and cGMP questions.
Providing in-house training tailored to your company needs on understanding compliance with the cGMPs regulations, facility requirements, quality systems, validation of manufacturing facilities, equipment cleaning and environmental monitoring.
Curriculum vitae available. Please contact us at (301) 260-2200 or email to dhai@msn.com.
