cGMP Services

How robust are your cGMP processes? Although your organization may perform repeated internal audits and reviews, are you certain that all deficiencies and gaps have been identified and addressed? An objective assessment from CompliaPharm is effective due diligence. CompliaPharm provides full assessments of Quality Systems with detailed feedback on areas of risk, recommendations, and plans for improvement.

Proper training, along with guidance and knowledge transfer from CompliaPharm, will help ensure your company is positioned to maintain and continuously improve your Quality Systems.

CompliaPharm can assist you with a broad scope of cGMP compliance including:

  • Development and implementation of quality systems
  • Assessment of existing quality systems 
  • Internal and external auditing
  • Training
  • Vendor qualification
  • CAPA
  • Comprehensive compliance programs 
  • Risk assessment 
  • Technical Writing
    • SOPs
    • Policies 
    • Protocols
    • Compliance Manuals
  • Vendor selection
  • Document control
  • Change control 
  • Supplier Quality Management
  • Quality Agreement negotiation
  • Process improvement
  • Gap analysis
  • Remediation
  • Assistance with FDA 483 and warning letter responses 
  • Recalls