Risk Evaluation Mitigation Strategies

Safety Surveillance and Risk Evaluation Mitigation Strategies (REMS)

Our expertise will help you to demonstrate that the benefits of your products exceed the risks by the greatest achievable margin, to identify potential risks at an early stage, and to identify strategies to minimise them globally.  

  • Development and implementation of REMS and Risk Management Plans (RMPs)
  • Medication Guide development and comprehension testing 
  • Execution of Post Authorisation Safety Study (PASS –interventional and non-interventional) 
  • Post-Authorisation Measures (PAMs) including SOB, PhV, ANX
  • Registry design and implementation
  • Literature Reviews