A Risk Evaluation and Mitigation Strategy (REMS) is a recent and emerging regulatory requirement whereby the FDA expects pharmaceutical and biotech companies to monitor, submit plans, and proactively manage safety risks as part of NDA submission and life-cycle management. Common risk management issues have included drugs with abuse potential, risk of fetal abnormalities, risk of QTc prolongation, risk of hepatotoxicity, drug-drug interactions, and polymorphic metabolism. The REMS program may include elements to assure safe use, a medication guide, a communication plan, an implementation system, assessment tools, and a timetable for submission of assessments.

How can Beckloff Associates help?

Beckloff Associates offers continuity of service from the early stages of a REMS program development to assessment of the program in the years after REMS approval:

• Strategic consultation for optimum REMS strategy
• Interpretation of FDA requests for REMS
• Preparation of REMS documents tailored to the client?s drug product
• Submission to FDA
• Preparation of tasks and timelines for successful implementation of REMS in partnership with client
• Web portal, database collection and call center services and management
• Registry design and management
• Patient, hospital, physician and pharmacy enrollment
• Pharmacovigilance oversight and post-marketing REMS element management
• Integration with reimbursement services through Health Connections, a Cardinal Health company
• REMS compliance and monitoring
• REMS assessments

Why choose Beckloff Associates:

• REMS submission preparation experience
• REMS oversight and management experience
• Expertise in Clinical, Nonclinical and Regulatory Affairs
• Significant label development experience
• Commercial launch readiness experience