Overview
A failed inspection can derail a product launch or shut down operations. Our former FDA and industry auditors conduct rigorous mock inspections and gap analyses to stress-test your Quality Management System (QMS). We identify vulnerabilities in your facility, equipment, and documentation before the regulators arrive.
Key Features
Our Process
Pre-Audit Planning
Defining the scope and agenda tailored to your specific risks.
On-Site Execution
Conducting the audit with the rigor of a health authority inspector.
Reporting & CAPA
Delivering a detailed report and helping you build a Corrective Action plan.
Frequently Asked Questions
Why Choose Us
- Reduced risk of Form 483s and Warning Letters
- Confidence in supplier quality
- Actionable remediation plans
- Staff preparation and coaching
Get More Details
Request a personalized consultation and detailed information about this service.
We'll respond within 24 hours
Ready to get started?
Contact our team to discuss your specific needs for GMP Compliance Audits.
Schedule ConsultationWhat Our Clients Say
"The mock inspection Adelphi ran was tougher than the real FDA PAI. When inspectors arrived, our team was ready. No Form 483."
Mark Stevens
QA Director
Contract Manufacturing Organization
Related Services
Explore other ways we can support your regulatory needs
Module 3 Authorship & Review
Comprehensive writing and critical review of CTD Module 3 (Quality).
21 CFR Part 11 Compliance
Validation and documentation support for electronic records and signatures.
Stability Data Assessment
Design and analysis of stability protocols to support shelf-life claims.