At SJ Pharma Consulting, LLC in Mendham, NJ, we have organized and carried out more than 100 safety audits and assessments since our establishment in 2001. Our team has created a 50-page audit checklist
that covers strategy, quality processes, organizational structure, SOPs, and systems and PV risk management.
Within each category of our checklist, multiple audit questions reference the applicable law, guidance, or regulation and the best practices that other companies currently use. With this approach, we see any compliance gaps present within the organization, which will be treated as a priority for remediation.