Authoritive source. Period.

Agatha Regulatory

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

Accelerate 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. A regulation management application is a must-have to help.

A Regulatory Solution

Agatha Regulatory is a comprehensive, ready-to-use regulation management 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. 

Use the application to collect, organize, and manage regulatory documents prior to submission, providing a single and authoritative source for all required content.

Agatha Regulatory Is…


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.

With Agatha Quality it is now possible to create a CTD that guarantees authenticity, readability, and storability in accordance with ER / ES guidelines. 

Mr. Kiyuki Tanifuji

Group Manager, Development Planning Group, Clinical Development Departmentget, Nihon Medi-Physics Co., Ltd.

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.

Learn how Agatha secures your data.

You Get More With Regulation Management

Custom Forms and Rendering

Leverage forms to drive processes based on metadata and use metadata to generate renditions.

Basic Preview and Annotations

Preview and annotate PDF, Office documents, and images.

Cross Workspace Reporting

Create views and reports across workspaces and export results to Excel for dashboard reports.

Extended Template Sets

Collect feedback from sites with Post Market Surveys and collect consent documents with Informed Consent.

Advanced Policy and Access Management

Manage policies, associated roles, and access controls easily.

Advanced Integration Toolkit

Use Agatha’s Rest API to allow applications to upload or export items from Agatha (includes documentation & sample code).

Get the Edition of Agatha That Works for You

Clinical eTMF
Remote Monitoring
SOP application
Quality Management Application
Regulatory Application

The best way to know if an Agatha Application meets your needs is to try it out. And good news - we offer a free trial.

Complete the form, select the application you would like to try and we'll reach out to get you set up as quickly as possible.

Want a little more information on your trial process? Go here.


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