Our GxP compliance services are designed to provide you assurance that your development activities will deliver quality investigational products and/or data which will pass regulatory scrutiny. Our compliance services allow Dunn Regulatory Associates, LLC to provide you an extra layer of insurance that your data when submitted to regulatory authorities will meet today’s increasingly challenging compliance standards.

Our services include:

  • GXP Compliance Monitoring and Auditing
    • Dunn Regulatory Associates, LLC conducts monitoring and on-site audits for organizations operating under GLP, GCP, and GMP compliance. These include nonclinical and clinical CROs, CMOs, bioanalytical specimen storage and testing laboratories, and Phase 1 clinical trial sites, as part of vendor qualification, routine, or for-cause monitoring and auditing. We offer a science-based approach to compliance which results in pragmatic solutions to compliance issues.
  • SOPS
    • Dunn Regulatory Associates, LLC can assess the adequacy and compliance of existing quality systems and implement stage-appropriate SOPs to ensure compliance and well-controlled development. We can develop standard operating procedures and associated forms.
  • Product Quality Oversight
    • Effective sponsor oversight of manufacturing and controls, for both investigational and commercial-stage products, is critical to any successful company. We ensure compliant QA oversight for manufacturing activities at internal vendors and CMOs. We are experienced in all phases of development, knowledgeable in the nuances of manufacturing and controls, and proficient in the review and approval of controlled documentation.