Compliance Services, GMP Compliance Consulting

Compliance services are conducted by a former FDA credentialed inspector in accordance with FDA regulations 21 CFR 210, 211,  and include:

• Mock FDA Good Manufacturing Practices (GMP) inspections and audits, to include gap analysis and list of recommendations, if desired
• Design and build GMP-compliant Quality Management systems, to include the Quality by Design concept
• Draft Quality Assurance Standard Operating Procedures (SOPs), Quality Agreements, Site Master Files, and Quality Manuals
• Lead and draft report for Annual Product Quality Review
• Prepare responses to Agency advisory actions, such as untitled and titled letters (Warning Letters) and Notice of Intent to Revoke (NOIR)
• Determination of compliance with Good Laboratory Practices (GLPs)(21 CFR 58), Good Clinical Practices (GCPs), Clinical Laboratory Improvement Amendments (CLIA), and Good Clinical Laboratory Practices (GCLP)
• Competency-based training in FDA cGMPs