Risk Management (RMP and REMS)

In today’s regulatory landscape, effective risk management is not just a requirement—it’s a critical pillar of drug safety. Every therapeutic product presents inherent risks, and without proper oversight, these risks can compromise both patient health and public safety. Regulators around the world now demand proactive, evidence-based risk assessment and continuous safety monitoring across the entire product lifecycle.

At Adaptis, our risk management experts design and implement comprehensive strategies that support both regulatory compliance and patient protection. We specialize in the development, maintenance, and submission of Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS), ensuring that your products remain safe, effective, and aligned with evolving global standards.

Our Risk Management Services Include:

• Development of Risk Management Plans (RMPs)
• Creation and Maintenance of REMS and REMS Update Reports
• Design and Implementation of Additional Risk Minimization Measures (aRMMs)
• Preparation of Educational Materials, DHPCs, and Pregnancy Prevention Programs
• Controlled Access and Targeted Follow-Up Questionnaires (TFUQs)
• Monitoring of USFDA Product-Specific Guidelines (PSGs) and EMA PRAC Recommendations

Our team combines strategic insight with regulatory expertise, offering tailored solutions to help sponsors stay ahead of safety expectations—across all regions and product types.