REMS Audits

Risk Evaluation & Mitigation Strategy (REMS) programs are required by the FDA for drugs that carry serious safety concerns and are designed to ensure the benefits of the medication outweigh the risks.  The goal is to reduce the occurrence and/or severity of medication risks by supporting the use conditions described in the FDA approved labeling.  REMS was introduced with the FDA Amendments Act of 2007 (FDAAA).  Globiox auditors can help ensure that a company’s REMS meets the requirements of FDAAA.

 

Check out our '7 Steps when Preparing for a REMS Audit' here

Downloadable Globiox '7 Steps for REMS Audit Prep' white paper

 

***Update as of April 8, 2021: Our experienced REMS Auditors are available to begin a REMS audit within one month following the signing of a contract.***