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Risk Assessment Audits

Supply Chain Monitoring

Remediation Services

Due-diligence Audits

Regulatory Responses

Remediation Services

Our multidisciplinary team of regulatory consultants works with you to remediate internal risks identified or externally driven enforcement actions. We provide a risk based approach to identify and focus remedial efforts on the highest risk aspects of the supply chain to effectively manage and collaborate with vendors. This risk-based approach can be adopted in several ways – selectively monitoring few products, or a few vendors, and a portion (finished products or packaging or API) of the supply chain based on the specific need.

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