Information or proposal request: REMS support option

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Related

• REMS Services
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• Risk Evaluation and Mitigation Strategies (REMS) under FDAAA
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REMS Submission and Management

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?

• Interpretation of FDA requests for REMS
• Preparation of REMS documents tailored to client drug products
• Preparation of tasks and timelines for successful implementation of REMS in partnership with client
• Pharmacovigilence oversight and postmarketing REMS element management

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