Owner & Principal

Douglas A. Campbell

Former USFDA compliance leader and CGMP specialist assisting global pharmaceutical teams navigate inspections, enforcement strategy, and Quality Risk Management with confidence.

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About

With 14 years at the USFDA and another 14 years in consulting, Doug brings a vast experience in inspection and enforcement policy, parenteral drug manufacturing, and Quality Risk Management. He is known for practical, risk-based guidance that prepares organizations for inspections, resolves technical and regulatory inquiries, and builds sustainable Quality Management Systems across complex, global operations.

Services

  • Gap Assessments / Mock Inspections
  • Direct support for Audit Programs
  • Support before, during, and after Regulatory Inspections
  • Enforcement Remediation / Conflict Resolution
  • Resolution for Technical Inquiries
  • Training Events

Contact

Let's discuss how we can strengthen your programs and build sustainable systems.