From standalone Desktop applications to enterprise submission tracking and electronic document retrieval systems,
and anything in between, ROSETTA Regulatory Software has solutions for you for managing and consuming eCTDs
and other related regulatory information.
For Smaller Life Science Companies:
ROSETTA Phoenix Desktop™ is a standalone, Windows application for viewing eCTD
and non-eCTD Electronic Submisions (NeES) prepared for Canadian, E.U.,
Japanese, Swiss, Taiwanese and U.S. regulatory agencies.
It is popular for its intuitive user interface and ease of use without compromising features or performance.
Almost all users can start using ROSETTA Phoenix Desktop and viewing eCTDs in no time without any training.
Many training organizations and Regulatory Affairs consultancies
have been using and/or recommending ROSETTA Phoenix eCTD Viewer as a tool to help their clients’ adoption of and transition
to the eCTD standard.
See ROSETTA Phoenix Server™ below for a web-based eCTD viewing tool with additional capabilities.
For Mid-sized Companies and Large Regulatory Affairs/Operations Departments:
ROSETTA Phoenix Server™ is a web-based solution that delivers the Phoenix eCTD Viewer as a plug-in/add-on (ActiveX control) to
Microsoft Internet Explorer (IE). It enables the navigation and retrieval of eCTD submissions over the web or intranets
through an IE browser. This architectural design allows for easy deployment and maintenance.
Not like the so-called "zero footprint" web solutions which suffer greatly from performance,
once the ROSETTA Phoenix eCTD plug-in is installed in end-users’ computers, users will enjoy the same rich, interactive
and intuitive user interface and high performance as the ROSETTA Phoenix Desktop Edition.
In addition, ROSETTA Phoenix Server provides the following capabilities:
- Unified web user interface for navigating and retrieving eCTD submissions stored in different repositories,
including fileshare and Electronic Document Management Systems (EDMS), such as EMC Documentum, Open Text LiveLink and
- Support Single Sign On across different repositories and security settings on document repositories are
honored by the system.
- (Optional) Integration with ROSETTA Annotation and Collaboration Services
to provide commenting capabilities during internal review process or after the submission of eCTDs to regulatory agencies.
Users’ review comments are stored in a database without altering submission documents while being seamlessly accessible
from right within the ROSETTA Phoenix eCTD Viewer user interface.
For Companies Using EMC Documentum
Keeping eCTDs (or other electronic submissions) on fileshares but not in Documentum docbases because inter-document hyperlinks do not work in docbases?
ROSETTA Phoenix for Documentum WebTop is a customized, out-of-the-box Documentum WebTop environment
where users can browse, locate, and view eCTD dossiers or submissions within Documentum docbases while preserving
navigatable hyperlinks between documents without altering the documents in any way.
It is integrated with ROSETTA Phoenix eCTD Viewer plug-in for full lifecycle view of eCTDs and the same
rich, interactive and intuitive user interface and high performance as the ROSETTA Phoenix Desktop Edition.
(See ROSETTA Pyramid™ below for a more comprehensive solution.)
For Large Enterprises and Companies Looking for More Than Just Viewing eCTD Submissions
Licensed by 3 of the world’s Global Top 10 pharmaceutical companies, ROSETTA Pyramid™
provides additional capabilities and values above and beyond viewing eCTDs.
ROSETTA Pyramid is a regulatory tracking system with integrated document repository for
two-way communications records between a Life Sciences company and regulatory agencies.
ROSETTA Pyramid™ comes with the integrated ROSETTA Phoenix eCTD Viewer to viewing eCTDs.
It also provides the capability to track, archive and instantly retrieve digitized paper submissions and
correspondence received from regulatory agencies within the same system.
Why separate your eCTD submissions from other submission records and regulatory correspondence,
and create silos of information?
Check out ROSETTA Pyramid™ and see what it can offer.