Gap Analysis - Compliance Reviews, Audit Readiness, & Due Diligence
Is your compounding operation cGMP, FDA, DEA, Board of Pharmacy, USP, PCAB, or NABP compliant? Ready for your next regulatory or accreditation audit? Need to perform regulatory due diligence to assess the feasibility or market value of a merger or acquisition? Our experts are compounding veterans, having spent their careers in 503A, 503B, and pharmaceutical manufacturing settings. We conduct comprehensive reviews, mock audits, and gap analyses to assess compliance with the applicable pharmacy or outsourcing regulations and accrediting bodies. We outline where the gaps are and if you like, we’ll fix them, too.
What We’ll Do
1. Audit - Conduct a Compliance Audit
2. Report - Provide a Review of Findings Report
3. Fix - Remediate the Issues