Risk Minimization Action Plans (RiskMAP)

FDA is expecting pharmaceutical companies to propose plans to proactively manage the risks of drugs with potential safety concerns as an integral part of the NDA submission process. ParagonRx^® supports this new RiskMAP discipline by offering the follow services:

• Risk Assessment — identifying potential interventions that address known product hazards using RxFMEA^®, a process oreinted risk assessment technique
• Prototype Development — designing effective interventions to manage risks
• Documentation for Regulatory Submission — incorporating program description into regulatory submissions
• Redesign and Scale-Up — adapting design from regulatory feedback and scaling up for launch
• Operations — integrating and managing program activities
• Measurement — assuring interventions and effectiveness of the program are quantified
• Reporting — providing program information to regulatory agencies and other stakeholders
• Modification — adapting program to increase benefit and reduce inefficiencies

The ParagonRx^® Difference

A Culture of Confidentiality