Intro

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

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