Gap assessments, mock inspections, and remediation plans aligned with FDA 21 CFR 210/211, 21 CFR Part 117, ICH Q7/Q10, and EU GMP. We get you ready for FDA, third-party, and customer audits.

What’s included

• Gap Assessments: A clear picture of where you stand against the applicable requirements.
• Mock Inspections: Realistic inspections that show what to fix before the real one.
• Remediation Plans: Prioritized, practical actions to close every gap.
• Regulatory Alignment: FDA 21 CFR 210/211, 21 CFR Part 117, ICH Q7/Q10 and EU GMP.
• Audit Preparation: Preparing your people and records for FDA, third-party and customer audits.
• Follow-Up Support: Help responding to findings and verifying that fixes hold.