Quality Assurance

  • Implementation of a Quality Management System (QMS) + guidance through inspection
  • cGxP audits
  • Pre-approval inspection preparation at sites
  • Mock inspections (FDA / EMA)
  • Release of investigational product
  • Release of commercial product batches
  • Standard Operating Procedure (SOP) writing
  • ISO certification management (9001, 13485)
  • CAPA management FDA483 resolution
  • Monitoring and co-monitoring visits
  • For-cause audits
  • Warning Letter remediation
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