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Risk Evaluation & Mitigation Strategies (REMS)

Guiding manufacturers in meeting FDA requirements to ensure the benefits of a drug or biologic product outweigh its risks

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 technological 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.

  • Consulting on all aspects of REMS & FDA interactions
  • Designing & implementing REMS, including Communication Plans and complex REMS with Elements to Assure Safe Use
  • Designing, fielding, & evaluating Knowledge, Attitude, Behavior (KAB) Surveys
  • Preparing FDA Assessment Reports
  • Compliance Monitoring and Reporting
  • Project Management Support
  • Coordinating Center Operations
UBC Expertly Manages Shared System REMS as the Project Management Organization (PMO)

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.

UBC as the PMO provides efficiency, experience and security.

Creating a Governance Charter:To govern rules and responsibilities for the Sponsors and PMO
Establishing a Document Repository:Managed by UBC, accessible to all Sponsors
Preparing FDA Submissions:Preparation of FDA correspondence and submission to regulatory authorities
Facilitating Onboarding of Sponsors & Vendors:Flexible process throughout a program
Providing Vendor and Financial Management Transparency and Reassurance:Visibility on activities and issues with safeguards to ensure proprietary information is not shared across companies


Shared System REMS supported by UBC


of 76 active REMS touched


REMS Elements to Assure Safe Use Programs developed


REMS Assessment Reports to the FDA

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