Inspection Readiness, Response & Remediation
- U.S. FDA Inspection Readiness
- International Inspection & Audit Readiness (EU Notified Body, PMDA/MHLW, CFDA, Health Canada, MDSAP)
- Pre-Inspection Gap Analysis & Remediation
- Mock FDA Inspection
- Lead and/or Support FDA Inspections
- 483, Warning Letter, Consent Decree Responses, Strategy, Planning, Remediation, Corrective Active & Preventive Actions
- Conduct Internal Quality Audits
- Clinical Quality Audits
- Endpoint Adjudication Committee (EAC) Audits
- Data & Safety Monitoring Board (DSMB) Audits
- Bioresearch Monitoring (BIMO) Inspection Readiness Audits
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