GLP Quality Consulting, LLC

Before deciding to use a Contract Research Organization (CRO), sub-contractor, or vendor we conduct an on-site inspection of the GLP compliance status and provide you a report of the strengths and weaknesses of the organization from a regulatory compliance standpoint.

We provide protocol and protocol amendment audits for GLP requirements and internal consistency.

We review GLP study data and reports for accuracy, completeness, SOP compliance, and regulatory requirements. 

GLPs require in process study inspections.  We will conduct these inspections at your site or at your contractor, as needed.

We will conduct inspections of your internal facilties/laboratories and provide a report describing areas for improvement and suggestions for resolving any compliance issues. 

Written standard operating procedures (SOPs), describing study procedures are required for GLP compliance.  We will work with your scientific staff to ensure the appropriate SOPs are in place and that they include elements necessary to meet applicable regulation.

Starting a new GLP-compliant laboratory/facility?  We can assist you by performing a site evaluation and identifying the steps needed to achieve compliance.

We offer GLP training and refresher training for your staff.  We can customize this training to meet your organizational focus/needs.

We have experience with FDA and EPA GLP facility and study inspections.  We can provide you with advice on how to prepare for, conduct, and respond to agency inspections.