Compliance

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