Regulatory Preparations
REMS Regulatory Documentation
At ParagonRx, we will work with you to develop a complete REMS document for FDA submission. No matter the requirements, from a Medication Guide, to a Dear HCP Letter, to an assessment protocol, our experienced safety experts and writers can help alleviate the burden and ensure that your submission is developed in compliance with FDA requirements.
Contingency Planning and Preparations for FDA Negotiations & Advisory Committee Meetings
ParagonRx offers full REMS documentation, negotiations support and a contingency planning process that includes "stress-testing" your plans and presentations against the toughest questions that others may pose, as well as mock panel meetings and scenario planning to anticipate decisions that would otherwise need to be made under time pressure.
90-Day Pre-PDUFA Date Action Planning
The last 90 days prior to approval are when proactive REMS strategy and contingency planning pay off. Many known and unknown factors can arise that could potentially affect or delay REMS approval. A well defined strategy, project plan, and contingencies can help assure that these factors don’t derail you from achieving your objective of timely REMS approval.
Assessment Development and Documentation
Assessing REMS effectiveness may entail developing protocols and survey instruments, combined with claims data analysis to document non-compliance and other post-marketing research. Protocols and instruments are a required part of the REMS submission.
The Advantage
With ParagonRx as your risk mitigation partner, you're not just submitting a program and hoping for the best. You're following an evidence and experience-based process that has aligned with regulatory and clinical needs for nearly a decade, working with experts who have literally "written the book" on what works.