FDA Inspections and Audits from other International Authorities as well as Certification Audits by Notified Bodies are becoming increasingly challenging for many companies. We support our clients to prepare and manage inspections and audits.

Inspection/Audit preparation

• Mock Audit with former FDA inspector
• Targeted deep dive assessments
• Inspection readiness Program
• Risk mitigation program
• Training of key personnel
• Organizational inspection set up including front and back office
• Professional interpreter
• Compliance / remediation program
• Communication with authorities
• 483 and Warning Letter response