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Risk Evaluation and Mitigation Strategies (REMS)

Rocky Mountain Poison and Drug Center has worked to provide Risk-MaPs and later REMS service and consulting to the pharmaceutical and biotech industries.  FDA may require REMS before approval if they determine it is necessay to ensure that the benefits of the drug outweigh the risk.  They can also require a REMS post-approval if they become aware of new safety information and determine it is necessary to ensure that the benefits of the drug outweigh the risks

Through our 24/7 call center environment, Research and Consulting Group, and RADARS System program, we have developed the expertise to help you with many parts for your REMS requirements.  Handling a Medication Guide as well as enrollment and certification is often an extension of your medical information/adverse event contact center.  We can also create/present CME as an indepent third party helping you meet this requirement.