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 and cell and gene therapies for rare diseases. Through technology innovation such as AE reporting, the use of real world data to generate evidence and virtual assistants, we reduce stakeholder burden, minimize barriers to access and ensure products’ safety and value.
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.