The Most Overlooked Factor in Faster RA Approvals? Regulatory Gap Assessments
A gap assessment acts as a diagnostic before the submission starts. It reveals discrepancies between what your dossier (or your design history file, software validation, clinical evidence, etc.) currently holds and what the target regulatory authority expects. Investing time upfront in a thorough gap assessment typically yields exponential returns: fewer cycles of “you missed this,” smoother exchanges with regulators, and a greater chance of first-pass approval.