Comprehensive Risk Management and Risk Minimization Services
At Soterius, we offer expert development and management of Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS), and additional Risk Minimization Measures (aRMM). Our specialized team ensures that all risk management documents meet global regulatory standards, including EMA, FDA, and ICH guidelines. By identifying, assessing, and clearly communicating product risks, we help sponsors implement robust strategies to minimize patient exposure and enhance overall drug safety.
Strategic REMS and RMP Development
Our experienced professionals develop tailored REMS and RMPs aligned with your specific therapeutic area, regulatory environment, and product safety profile. We collaborate closely with sponsors to design practical, effective risk minimization tools, including educational materials, controlled distribution programs, and patient communication strategies. Our proactive approach ensures that risk management documents effectively address safety concerns, support regulatory approvals, and protect patient well-being.
