REMS Submission and Management
Information or proposal request: REMS support option
New documents coming soon.
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