Risk Evaulation & Mitigation Strategies (REMS)

Not an obstacle – an opportunity.

Don’t look at Risk Evaluation Mitigation Strategies (REMS) as an obstacle – look at them as an opportunity for faster FDA approval. The FDA focus on risk requires that manufacturers bear responsibility for the safety of a new drug or biological product. When you’re developing a drug, the FDA may require manufacturers to produce information that illustrates how the benefits of your product outweigh the associated risks.

REMS Elements


We can help guide you through the REMS and risk mitigation process with advice such as:

Rely on Centric Health Resources as your trusted partner for REMS and risk mitigation and give your product the best opportunity for FDA approval.