MMS Holdings Expert Insights Blog

Experts at MMS share their insights on trending
topics in the pharmaceutical industry.

Good Laboratory Practice (GLP): A Validation Approach

Good Laboratory Practice (GLP): A Validation Approach

Good Laboratory Practice (GLP) is a quality control system for clinical research laboratories and organizations to ensure the integrity, consistency, and reproducibility of the data within non-clinical and clinical studies of products in development for human or...

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FDA REMS Programs: Five Major Components for Compliance

FDA REMS Programs: Five Major Components for Compliance

The US Food and Drug Administration (FDA) Amendments Act of 2007 authorized the FDA to require a Risk Evaluation and Mitigation Strategy (REMS) Program. The REMS program is required if it is determined that specific safety measures are needed to ensure that a drug’s...

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