GLP Quality Consulting, LLC

GLP Quality Consulting, LLC

ph: (734) 222-6285
alt: (734) 277-5340

GLP Services

  • CRO, Subcontractor and Vendor Inspections

    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.

  • Protocol Reviews

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

  • Data and Report Audits

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

  • In-Process Study Inspections

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

  • Facility Inspections

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

  • Standard Operating Procedures

    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.

  • GLP Implementation

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

  • GLP Training

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

  • Regulatory Inspection Preparation

    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.

Areas of Compliance Expertise Include:

  • General Toxicology
  • Pathology
  • Analytical Chemistry
  • Bioanalytical Sample Analysis
  • Toxicokinetics and Pharmacokinetics
  • Drug Metabolism (ADME)
  • Genetic Toxicology
  • Clinical Pathology
  • Reproductive Toxicology
  • Histology
  • Computer Validation
  • Archives
  • Bioanalytical Method Validation

For more information please contact us.

Copyright 2009-2010. GLP Quality Consulting, LLC. All rights reserved.

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GLP Quality Consulting, LLC

ph: (734) 222-6285
alt: (734) 277-5340