Many dossiers are still not submitted in a harmonized electronic dossier format, often due to the lack of availability of a dossier management and publication tool. Authorities are about to individually develop web portals, leading to intransparent, labor-intensive and error-prone manual information collection as well as to an increasing lack of harmonization and possibility of data exchange within the regulatory world.
The following screenshots give you an impression of the functionality and look-and-feel of the software:
Why an ECPA eSubmission builder ?
- Boosts electronic submissions in companies
- Shows easy creation and management of reference data, documents and submissions in one tool, especially for small and medium-sized companies
- Manages different versions of documents and dossiers
- Easily submit a single dossier to multiple authorities with differentrequirements
- Promotes identification and tracking of input from different legal entities
- Provides transparency throughout the dossier life cycle
- Simplifies work sharing
- Increases efficiency
- Improves communication
- License-free, non-proprietary and extensible
- Modern easy-to-use web-based solution
- Single-user desktop application
- Lightweight application to meet core needs of electronic submissions
- Generates submissions in CADDY-xml and GHSTS format
- Contains both document management and dossier management functions with metadata fit for purpose
- Different deployment options (easy extensibility to cloud deployment)
- Source code available on demand
- Extensible to fit individual needs (e.g. connection to inhouse systems, custom metadata)
- Commercial extensions and services are permitted
Release roadmap - call for action
The current first release is a beta testing version to obtain feedback from all interested parties. Please participate in the testing phase.
The public testing phase will end on July 17th, 2020. Please use the different contact options to provide your feedback and findings.
A service release to round-off existing functionality and for bugfixing is planned for late Q3 / beginning of Q4 2020. As of now there ECPA hasn't decided about further future versions. The ECPA eSEG invites all parties to contribute and maintain the eSubmission builder.
Further information about the eSubmission builder:
- How to download, install and run
- Demo video
- Frequently Asked Questions
- What's new (permanently updated upon user feedback)
- Brief Online help (also accessible as context help from within the eSubmission builder)
- PDF brochure (see the Download section)
Contact and support information
There are a number of contact options via Email (clicking the link should open your email program automatically):
- ghsts_supportecpa [dot] eu (subject: Builder%20-%20Bug%20Report) (Report bugs)
- ghsts_supportecpa [dot] eu (subject: Builder%20-%20Feature%20Request) (Raise feature request)
- ghsts_supportecpa [dot] eu (subject: Builder%20-%20Support%20Request) (General eSubmission builder support request)
Please note that ECPA can only provide generic and software-related support and cannot assist with specific installation or integration issues. You are invited to still raise a support request so ECPA has an overview of the types of usages and issues.
- Download page for current eSubmission builder version
- Download page for outdated eSubmission builder versions (archive only)