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From stand-alone 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.  

Extended eCTD Software Product Lineup
From stand-alone 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 stand-alone, 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 consultancy have been using and/or recommending ROSETTA Phoenix eCTD Viewer as a tool to help their clients’ adoption of and transition to eCTD standard. Learn more...

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 so-called "zero foot print" 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 Microsoft SharePoint.
  • 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 seamlessly accessible 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 separating your eCTD submissions from other submission records and regulatory correspondence, and creating silos of information? Check out ROSETTA Pyramid™ and see what it can offer




ROSETTA Phoenix eCTD Viewer Desktop Edition
: Stand-alone Desktop application for viewing eCTDs on local hard drives or fileshares
ROSETTA Phoenix Server: Web-based solution providing unified user interface for viewing full life cycle of eCTDs stored on file shares and in various Electronic Documentum Management Systems.
Connectors for EDMS: With ROSETTA Phoenix Server Connectors for Electronic Document Managment Systems, users can view eCTDs stored in an EDMS such as EMC Documentum, Open Text LiveLink and Microsoft SharePoint.
ROSETTA Annotation and Collaboration Services (RAACS): When combined with ROSETTA Phoenix Server, RAACS turns the ROSETTA Phoenix eCTD viewing envrionment into an eCTD reviewing system and project management tool. Users can comment on outgoing eCTD submissions and manage QC and approval processes.
ROSETTA Phoenix for EMC Documentum provides users the familiar Documentum WebTop interface to navigate and browse to an eCTD sequence or dossier folder, and then launch the web-based ROSETTA Phoenix eCTD Viewer with the sequence or dossier loaded in the Viewer.
ROSETTA Pyramid: goes beyond eCTDs and allows the tracking and viewing of submissions in eCTD, paper and other formats. Incoming correspondence from regulatory authorities can also be tracked in the same system to provide you the compelet chronology of your interaction with agencies.
 
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