Authoritive source. Period.

Agatha Regulatory

A complete, centralized location for collecting, coordinating and managing all the information and documentation required for regulatory submissions.

Agatha Regulatory lets you collect, organize, and manage regulatory documents prior to submission, providing a single and authoritative source for all required content.

Accelerating Regulatory Approval

Obtaining regulatory approval is the single most important step in bringing new drugs, devices, and therapies to market. Success means patients get new options sooner, while mistakes mean delays that waste time and money.

Agatha Regulatory is a comprehensive, ready-to-use application that addresses the challenge of creating a unified set of submission documents from content that is often created in many locations, sometimes in many countries. 

Using Agatha Regulatory, regulatory and compliance professionals are able to create a centralized set of documents from a decentralized process, simplifying and accelerating the submission process.  



Cloud-based, preconfigured, validated and
ready to use.

Consistent, Complete

Based on the EDM Reference Model, it automatically identifies missing documents. 

Coordinated, Collaborative

Online review of documents with shared annotations as well as review & approval workflows.

Validated, Compliant

Fully compliant with 21 CFR Part 11, as well as EU Regulatory Requirements.

On The Need for Accuracy:

“The FDA may refuse to file (RTF) for NDAs and BLAs, or refuse to receive (RTR) for ANDAs, an electronic submission that does not have study data in conformance to the required standards specified in the FDA Data Standards Catalog.”

Heather Crandall

Division of Data Management Services & Solutions, Office of Business Informatics, CDER, FDA

Agatha Regulatory Features


Simultaneous online review of documents with shared annotations.

view submissions

Browse submission archives in the application using the submission viewer.

eCTD Integration

Out-of-the-Box integration with most eCTD submission software products.

Based on Standards

Agatha Regulatory is based on the standard EDM Reference Model.

Track Applications

Track regulatory applications and health authority correspondence

What's Missing

Identify missing sumbmission items automatically at any point in the process.

Agatha Applications

Clinical eTMF
Remote Monitoring
SOP application
Quality Management Application
Regulatory Application

The best way to know if Agatha Applications are right for you is to try them.

Fill out the form and select the application you would like to try for free for 21 days.


Not sure if you are ready for a trial? Learn more about our trial period to know if it's right for you.

And if you still aren't ready - we'd love to show you a demo.

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