REMS Product Management

California Specialty Pharmacy can support and manage a REMS program aligned with the goals of the manufacturer. We offer:

  • Project management responsible for the internal cross function for the program
  • Identification of multiple REMS strategies which anticipate all potential scenarios, including FDA responses
  • Leveraging of efficiencies to maximize performance and mitigate costs
  • Anticipation of future needs and plan for scalability
  • Timely reporting of information to manufacturer
  • Ongoing analysis of program effectiveness and needs for improvement
  • Preparation for auditing
  • California Specialty Pharmacy has experience managing REMS programs across multiple disease states, including programs ranging from medication guides to ones requiring Elements to Assure Safe Use (ETASU).