Authoritive source. Period.
A complete, centralized location for collecting, coordinating and managing all the information and documentation required for regulatory submissions.
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.
Based on the EDM Reference Model, it automatically identifies missing documents.
Online review of documents with shared annotations as well as review & approval workflows.
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.”
Agatha Regulatory Features
Simultaneous online review of documents with shared annotations.
Browse submission archives in the application using the submission viewer.
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 regulatory applications and health authority correspondence
Identify missing sumbmission items automatically at any point in the process.
Inspection-ready Management of Essential TMF Documents and Records
Creation, Review and Approval of SOPs and Employee Training Records
Quality Document and Process Management for CAPAs, Deviations, & Change Control
Easily manage your regulatory documentation following the EDM Reference Model.
But not just any trial - an Agatha trial.
Agatha offers a fully supported free pilot where you can test our applications using your real information and processes.
Just fill in the form
and we’ll get right back to you to get you set up.
If you're not sure, you can learn more about our Pilot process here. If you’re not quite ready to sign up for the pilot, request a demo instead.