• GMP (good manufacturing practice) for intermediates, active pharmaceutical ingredients (APIs), and finished drug products
• QSR (medical device "GMP")
• GCP (good clinical practice)
• GLP (good laboratory practice)
• GPP (good promotion practice)
• DEA (Drug Enforcement Agency)

• Performing "mock" FDA pre-approval inspections-helping to ensure that problem areas are identified and addressed before the real inspection
• Developing drug diversion prevention and counterfeit investigation programs
• Helping organizations ensure compliance with the Prescription Drug Marketing Act (PDMA)
• Auditing adverse drug event (ADE) programs-from collection and evaluation through reporting and follow-up
• Qualifying vendors
• Performing due diligence
• Conducting regulatory audits
• Auditing documentation, including application integrity audits
• Verifying activities of the regulatory committee

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