RegCheck™ Features

First column

Utilizes a proven process developed by regulatory professionals

Resides in a secure, private cloud and is accessed using any standard internet browser

Assigns user-friendly checklists based on the type of study and provides an audit trail based on each user’s unique log-in

Checklist elements are annotated to 21 CFR and guidance documents for easy reference

Provides thorough program status updates throughout drug development

Second column

Generates real-time reports that:

  • Flag and prioritize deficiencies into critical (red), major (blue) and minor (green) categories
  • List deficiencies with required or suggested corrective actions
  • Identify studies that may need to be repeated or amended and areas requiring additional explanation or information
  • Note missing and/or illegible pages so that they may be handled efficiently
  • Provide confirmation that documentation is complete