Our GxP Compliance team provides a full range of consulting services to our pharmaceutical, biotech, and medical device clientele. We are focused on exceeding the regulatory requirements for compliance with US, European, and Canadian agencies and organizations. 

Compliance Services:

  • cGMP, GCP, GLP Strategy Development
  • Third Party, Supplier, QSR Computer System Vendor Audits & Inspections
  • Mock FDA QSR/cGMP, GCP, and GLP Inspections
  • Due Diligence Auditing
  • IT Remediation Strategies (consent decree driven)

Validation Services:

  • Validation Program Development, Strategies & Master Planning
  • Part 11/Annex 11 Compliance
  • Protocol Development, Execution, Review, and Summary Report Development/Review
  • Third Party Review & Project Management
  • Validation Remediation/Special Projects, including interim control solutions
  • Validation Baseline Assessments, Risk Analysis, & GAP Analysis