GMP/GLP Compliance Consulting and Quality Systems Development

The success of your business is intrinsically linked to quality. Our compliance team understands this and works closely with technical experts in nonclinical development and CMC to ensure phase-appropriate application of key GLP and GMP elements. We will design standalone quality management systems (QMS) tailored to your business and to meet applicable regulations, while incorporating a life cycle approach focused on continuous improvement.

Our services are flexible, whether you need to establish a new QMS to address the core elements of your business, enhance or improve an existing QMS, or establish a “rescue plan” related to specific regulatory compliance problems. Services include:

  • Development of integrated project-specific quality plans
  • Supply chain evaluation
  • GMP and GLP compliance audits
  • Site and system inspection readiness oversight and training
  • “Mock” regulatory agency inspections, including Pre-Approval Inspections (PAIs), performed to FDA, EMA, MHRA and PIC/S standards
  • Phase-appropriate Quality System design, implementation and training
  • Due diligence in support of in-licensing and out-licensing activities
  • Evaluation, risk assessment, strategy development and management of corrective action associated with regulatory compliance, including inspection observations, FDA “483s”, Warning Letters, Consent Decrees