• Gap Analysis to first GLP
    CROs and Laboratories: 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.
     

  • Independent Internal Audits at GLP/GCLP CRO – Prep for Inspection
    We will prepare your organization for the routine National Monitoring Authority inspections by performing an independent GLP/GCLP audit and review the resulting observations and corrective actions prior to inspection. Our services include post inspection support.

     

  • Preparation for MOCK inspection 
    We will perform an independent audit to prepare your company to a regulatory inspection (FAD or other), followed by reviewing with you the observations, CAPA plan and corrections.