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‚ÄčRisk Assessment Audits

Supply Chain Monitoring

Remediation Services

Due Diligence Audits

Regulatory Responses

  • Risk assessment audits: Dipstick to diagnose and develop supply chain vendor risk profiles and develop a critical process parameters that generate risk for the specific business
  • Supply chain monitoring:  Continuous monitoring, identification and reporting of risks and issues
  • Remediation services:  Mitigating risks identified by MedAssure or post-regulatory action
  • Due diligence audits:  Audits and assessments of suppliers and partners to support mergers and acquisitions
  • Regulatory responses: - Services to support negotiations with FDA and DOJ post-regulatory action

The MedAssure solution is built upon the following elements. They provide a systematic approach to addressing the need, and are in agreement with the historical precedence and evolving regulatory mandates.

  • Ongoing data collection: Collect critical-to-quality parameters in a non-intrusive manner across all supply chain partners
  • Risk parameter analysis: Ongoing quantitative and qualitative analysis of the parameters collected
  • Anomaly identification: Identification and confirmation of anomalies
  • Risk communication:  Providing periodic reports and alerts appropriate to different decision making forums within the management structure