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Drug Safety Risk Evaluation & Mitigation

Safety Data Analysis and Risk Management Reporting for New Product Registrations and Labelling Updates

ClinChoice’s team of physicians and product specialists collaborate to design and prepare risk mitigation plans (RMPs) and risk evaluation and mitigation strategies (REMS) to support marketing authorization applications to the FDA and EMA. Our objective is to identify potential problems and address any issues that may arise before they escalate.

Our experience includes preparation of:

  • Safety information reviews & revisions
  • All sections of medical assessments
  • Full safety profiles
  • Risk-related position papers
  • Risk-benefit evaluations
  • Integrated summaries of safety (ISS)
  • Product expectedness lists

Our safety experts are also qualified to assist you with:

  • Oversight and Tracking of Medical Monitoring
  • Thorough Literature Searches and Assessments of Epidemiology
  • Identification of Significant Risks and Missing Information
  • Reviewing and Determining Adequate Routine and Additional Risk Minimization Measures
  • Creation of Submission-Ready RMPs
  • Assessment checks to document the effectiveness of risk mitigation strategies