Quality and Compliance Consulting

GMP Compliance Consulting services are conducted by a former FDA credentialed inspector. FDA GMP regulations  21 CFR 210 and 211 plus Guidelines serve as the standard GMP Compliance Consulting services include:

• Mock FDA Good Manufacturing Practices (GMP) inspections and audits, to include gap analysis and list of recommendations, if desired

• Evaluate PreApproval Inspection (PAI) readiness through the conduct of mock FDA PAI

• 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), and Form FDA 483 observations

• Determination of compliance with Good Laboratory Practices (GLPs)(21 CFR 58), Good Clinical Practices (GCPs), and Good Clinical      Laboratory Practices (GCLP)

• Conduct due diligence GMP compliance assessments for acquisitions and other investment decision making