Compliance Remediation

We support your organization if you need a fast response to a critical situation eg. FDA deficiency or warning letters, recalls, customer complaints or other critical quality issues. We can provide project management and/or a highly specialized team to help provide the competencies you need to solve the issues.

We help perform

  • A strategic approach to re-gain compliance and trust based on gap and risk analyses including an implementation plan for corrective actions
  • Preparation and approval of policies and SOPs
  • Facility walks, pre-inspections and plan for required corrective actions
  • Preparation and/or QA-approval of Corrective and Preventive Actions (CAPAs)
  • Preparation and/or QA-approval of Change Requests
  • Preparation for presentations to the FDA inspectors
  • a.o.

 

Our other services:


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