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

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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.

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