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Client Challenge
A pharmaceutical company faced regulatory scrutiny for one of its high-risk marketed products. The product’s safety profile had raised concerns among health authorities, and the client needed to develop a robust Risk Management Plan (RMP) to address these issues while maintaining market authorization. The challenge was to create a comprehensive RMP that not only satisfied regulatory requirements but also ensured patient safety and minimized risks.
PVigi’s Solution
PVigi stepped in to design and implement an Effective Risk Management Plan tailored to the client’s product and regulatory environment. Our approach included:
Risk Identification and Assessment
Development of Risk Minimization Measures
Controlled Distribution
Enhanced Monitoring
Regulatory Alignment
Ongoing Monitoring and Evaluation
Outcome
Regulatory Approval: The RMP was approved by regulatory authorities, allowing the product to remain on the market.
Enhanced Patient Safety: The implemented measures significantly reduced the occurrence of adverse events and improved patient outcomes.
Strengthened Market Position: The client’s product regained trust among healthcare professionals and patients, leading to sustained market performance.
Proactive Risk Management: The client adopted a proactive approach to risk management, setting a benchmark for future products.