Confidence Beyond Compliance

Assessment and Planning

  • Assessment of Regulatory Enforcement Action
  • Remediation Planning – Product, Process & Culture
  • Full QMS Gap Assessment
  • Site Quality Planning
  • CAPA Remediation Planning
  • Communication Planning
  • Response Writing to Regulatory Agency
  • Support for Agency meetings

Compliance

  • CAPA Implementation (process and product remediation)
  • Workstream Support and/or Leadership – including CAPA support, procedural revisions, employee training, records remediation, supplier audits, product regulatory filings
  • Organizational Design
  • Periodic progress updates to Regulatory Agency
  • Quality Culture Activities Implementation
  • Metrics Development

Effectiveness

  • CAPA Effectiveness Reviews
  • Metrics Monitoring, including product Post-Market Surveillance
  • Inspection Readiness Training and Preparation
  • Quality Culture Surveys
  • Internal Auditing
  • Regulatory Intelligence Monitoring
  • Re-inspection Support

Efficiency

  • Improvement Planning and Implementation to sustain compliance and effectiveness of remediated processes.
  • CSV Support for process IT tool implementation
  • Outsourcing Solutions for “Right-Sizing” staffing and maintaining process effectiveness and efficiency