Minervate

Our services

  • Good Clinical Practice (GCP)
  • Good Manufacturing Practice (GMP)
  • Computer Systems Compliance Management
  • Good Clinical Laboratory Practice (GCLP)

GMP Services

  • Data Integrity Assurance: Computer System Validation and Data Integrity Governance
  • GxP Compliance: Quality Management Systems (QMS) Implementation, and Optimisation
  • Strategic Inspection readiness services
  • Regulatory Intelligence
  • GAP analysis services
  • Risk assessment & Mitigation
  • GMP Regulatory Training.
  • SOP/Policies Development (authoring and review)
  • Compliance Management/Execution
  • Vendor Management and Qualification/Performance management
  • Quality Metrics Implementation
  • Audit Management
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GCP/GcLP Services

Minervate
  • Audit Management
  • Computer System Validation and Data Integrity Governance/migration
  • GxP Compliance: Quality Management Systems (QMS) Implementation, and Optimisation
  • Strategic Inspection readiness services
  • Regulatory Intelligence
  • GAP analysis services
  • Risk assessment & Mitigation
  • GxP Regulatory Training.
  • SOP/Policies Development (authoring and review)
  • Compliance Management/Execution
  • CRO/Vendor Management and Qualification/Performance management
  • Computer System Validation
  • Quality Metrics Implementation
  • GCP review of study documentation/TMF review