Agatha’s immediately available regulatory module enables organizations to manage regulatory documents prior to submission, and to browse the existing submission archives.
In addition to a complete set of document management functions, Agatha provides unique capabilities to greatly improve your organization productivity and compliance including:
- Collaboration with external partners.
- Management of expected documents per product (as per the EDM Reference Model).
- Integration with eCTD submission software.
- Online review of documents with annotations.
- eCTD import and viewer with link remap.
- View applicable documents across several submission sequences.