Proactive inspection readiness to save time and money in the 
long term.
The Challenge
Evolving regulations mean inspection readiness is continually changing as well. Short-staffed teams face pressure to cut costs and avoid fines. Satori has worked directly for the FDA and on behalf of clients with regulators from the US, EU and Japan. We understand what regulators look for during inspections, and how to engage them outside of inspections.
what we deliver
We help clients proactively prepare people and processes to satisfy regulatory compliance needs.
- Mock Inspection Drills
- Inspection Readiness Assessment
- Pre-Inspection Preparation
- Post-Inspection Response and Follow-Up
- CAPA Development, Management, and Remediation
- Remediation Management (for issues requiring less than a full CAPA)