Humphrey Regulatory Consulting (HRC) is a Florida based corporation with staff and resources across the US and the globe. Headquartered in Miami — one of the central hubs of global trade — HRC provides regulatory expertise to entrepreneurs, corporate giants and international business.

We offer strategic and technical advice at all levels, from development to distribution, delivering results for our clients through a combination of experience and problem solving strategies. Our clients contact us when requiring regulatory expertise and find themselves under pressure to deliver results. Our regulatory consultants give advice when information is difficult to obtain. Our clients can call us when they need to make decisions that will have major consequences for their people, their organization, and their regulatory approach to be compliant with in the regulated marketplace.

We offer our clients:

  • GCP and cGMP Strategy
  • GCP and cGMP Audits and Assistance
  • PAI and Regulatory Audit Inspection Readiness Training
  • Third Party or Supplier Audits and Assessments
  • Quality and Compliance Governance Assessments and Loaned Executives
  • Due Diligence of Potential Product and Facility Acquisitions
  • Assistance during inspections and post-inspection correspondence and meetings
  • Assistance and expert consulting to legal counsel in FDA enforcement matters

Additionally, we assist our clients in responding to FDA 483s, warning letters, injunctions, prosecutions, detentions, refusal, customs penalties and import alerts. Our expertise in promotion and advertising, labeling issues, exports and imports, MDR reporting, QSR and GMP requirements and other regulatory issues provides our clients with the confidence and security that their products and processes are compliant in a cost-effective manner.