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RegCheck™ Features
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
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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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