Owner & Principal | Regulatory & Compliance Consultant

Douglas A. Campbell

Former U.S. FDA compliance leader and CGMP specialist helping global pharmaceutical teams navigate inspections, enforcement strategy, and quality risk management with confidence.

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About

With 14 years at the U.S. FDA and nearly 15 years in consulting, Douglas brings deep experience in inspection and enforcement policy, parenteral drug manufacturing, and Quality Risk Management. He is known for practical, risk-based guidance that helps organizations prepare for inspections, resolve technical inquiries, and sustain compliance 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 compliance program and build lasting regulatory confidence.