UBC designs, implements, and analyzes more Risk Evaluation and Mitigation Strategies (REMS) than any other risk management services organization. UBC has an industry-leading reputation with Sponsor companies as well as with the FDA – we are known as leaders in providing comprehensive risk management and REMS. We have a dedicated focus on specialty products.
To avoid marketplace confusion of different REMS for referenced listed products and generics, the FDA may require Sponsors to establish a REMS consortium to work together to establish a single shared system REMS that includes multiple prescription drug products and is implemented jointly by two or more applicants. However, companies traditionally have different processes, procedures, and opinions. Therefore, achieving agreement on all topics may need to be brokered, and it is important to ensure responsiveness from all Sponsors.
To govern rules and responsibilities for the Sponsors and PMO
Managed by UBC, accessible to all Sponsors
Preparation of FDA correspondence and submission to regulatory authorities
Flexible process throughout a program
Visibility on activities and issues with safeguards to ensure proprietary information is not shared across companies