Is Your Program Ready for GLP?

Is Your Program Ready for GLP?

September 1, 2026

Five Questions That Strengthen Definitive Preclinical Study Planning

A definitive GLP study should build on the work that came before it, with a clear regulatory objective, a study design capable of supporting that objective, and a team prepared to execute it reliably. This Expert Brief introduces five questions to help medical device teams identify potential gaps before committing to definitive preclinical testing.

Inside this Expert Brief:

  • Defining the regulatory or development decision the study must support
  • Determining whether technical, procedural, and feasibility questions have been resolved before GLP
  • Building a study design that supports clear, defensible conclusions
  • Evaluating CRO proficiency, operational readiness, and consistent study execution
  • Assessing whether the resulting evidence will remain relevant through regulatory submission

This Expert Brief was developed with input from medical device regulatory strategy expert Sam Gilbert, VMD, following the webinar Regulatory Strategy for Medical Device Preclinical Programs.

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