Gap Analysis for CROs and Laboratories; GLP/GCLP
We will prepare your organization for your first GLP/GCLP Accreditation/Compliance by performing a deep and detailed Gap Analysis. We will provide recommendations for corrective actions to upgrade the company quality into Compliance Level. Our services include supporting the days of inspection and post inspection activities.
Independent Internal Inspection
We will perform an independent internal audit at your facility, followed by reviewing with you the observations, CAPA plan and corrections.
Internal Audit can be also focused in the QMS as part of your independent yearly audit support to your QA unit.
Preparation & Support & Training for regulatory inspections
We can prepare your employees for the routine National Monitoring Authority inspection / FDA inspection; start with an independent mock inspection, report observations, support in the preparation of CAPA plan and consulting, training for employees behavior during regulatory inspection, support during the inspection and handling of the inspection report.
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