REMS Submission and Management


Information or proposal request: REMS support option

To request more information or a proposal for a REMS support option, please complete this form.

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