Confidence Beyond Compliance
Remediation Consulting: End-to-end Leadership and Support Services for Remediation
The Safis MDS team are experts with many years of experience with Regulatory Agencies and remediation activities. We specialize in helping our client’s determine their remediation pathway as well as correspondence with regulatory agencies and eventual readiness for re-inspection. We assist with all three critical areas of remediation, namely Product, Process and Culture.
Our Services include full support for remediation projects from analysis of any regulatory enforcement action to development of remediation plan through development of CAPA and execution of CAPA and monitoring of effectiveness. We also assist with improvements to ensure on-going sustainability of the QMS after remediation and preparation for re-inspection by regulatory agencies.