GLP GAP Analysis

Issue

S & H was contacted by a CRO to perform an assessment of their capability to offer GLP bioanalytical services.

Stubbs & Hensel Intervention

  • Protocol: S & H created a laboratory inspection protocol designed to assess the capabilities of CROs to effectively carry out GLP bioanalysis with minimal regulatory risk. 
  • Inspection: S & H spent a day on-site to interview staff and execute the inspection protocol. 
  • GAP Analysis Debrief: We then prepared a comprehensive report along with a GAP analysis presentation and spent another half-day on site to debrief with the CEO and CRO key personnel.
Category: 
Project Management