Gap Analysis - Compliance Reviews, Audit Readiness, & Due Diligence
Whether you're preparing for an upcoming inspection or conducting due diligence for a merger or acquisition, our experts help you assess and strengthen compliance across regulatory frameworks—including cGMP, USP <797>/<795>/<800>, FDA, DEA, PCAB, and NABP.
Our team of experts—drawn from 503A, 503B, and pharmaceutical manufacturing—conducts detailed mock audits, gap assessments, and full compliance reviews tailored to your operation type and regulatory exposure.
We don’t just identify the gaps—we help you close them. From initial readiness to remediation, we ensure you’re equipped to meet your next audit with confidence.
What We’ll Do
Pre-Audit - Review Documents & Prepare a Checklist
Audit - Conduct a Compliance Audit
Report - Provide a Review of Findings Report
Fix - Remediate the Issues