Accelerate Regulatory Approval
A Regulatory Solution
Use the application to collect, organize, and manage regulatory documents prior to submission, providing a single and authoritative source for all required content.
Group manager Development Planning Group, Clinical Development, Nihon Medi-Physics Co., Ltd.
How Agatha Regulatory Helps You
Browse submission archives in the application using the submission viewer.
Out-of-the-Box integration with most eCTD submission software products.
Track regulatory applications and health authority correspondence.
A Few More Agatha Regulatory Features
Based on Standards
Agatha Regulatory is based on the standard EDM Reference Model.
Simultaneous online review of documents with shared annotations.
Identify missing sumbmission items automatically at any point in the process.