Authoritive source. Period.
A complete, centralized regulatory management application for collecting, coordinating and managing all the information and documentation required for regulatory submissions.
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.
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.
With Agatha Quality it is now possible to create a CTD that guarantees authenticity, readability, and storability in accordance with ER / ES guidelines.
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.
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
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
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
- Pre-validated functionality for core ClinOps processes
- Check-in, Check-out, and Version Control
- Electronic Signatures and Complete Audit Trails
- Flexible review and approval workflows
- Full compliance with 21 CFR Part 11 and related Regulations
- All Standard Features, Plus
- Advanced reporting with Metrics and Dashboards
- Live Co-annotation for simultaneous review of documents
- Custom forms capability
- Advanced, role-based access management
- Everything in Extended
- “In Application” Microsoft Word and Excel editing – No Word required
- Live collaborative authoring and editing
- Extended template sets for SOPs, Informed Consent, and more
- Integration toolkit with Rest API support
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.