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  ROSETTA Phoenix eCTD ViewerROSETTA Pyramid Regulatory Tracking SystemROSETTA eCTD Reviewing System
Licensed by five of the world's largest life science companies and downloaded by thousands of Regulatory Affairs professionals, ROSETTA regulatory software has the quality you can trust and the ease of use you desire. From Desktop applications to enterprise solutions, DoubleBridge has packages that meet your requirements and budget  

PLEASE NOTE: The latest version is R4.2 available in English and can be downloaded here.

ROSETTA Phoenix Desktop™ eCTD Viewer R3.0.6 provides user interface in Chinese, English, French, German and Japanese.

If you'd like to try ROSETTA Phoenix Desktop™ R3.0.6, there are two download and installation options:

  • (Recommended) If you have administrative privileges to install software on your computer or your Technical Support can install the software for you, download and run this Setup program (2.29 MB). The Setup program will guide you through an easy installation process, step by step, including creating a shortcut on your computer Desktop.
  • If you do NOT have administrative privileges to install software on your computer,
    Download this compressed (.zip) file (2.55 MB). After you download the file, uncompress/extract it to a folder. Double-click the "ROSETTA Phoenix.exe" file to run the software and proceed to activate the software.

You will need a trial license key to activate the software and view eCTD submissions. Please contact us at freetrial@doublebridge.com to obtain a 30-day trial license for free. For commercial use, please send your inquiry from a company email address - we generally do not respond to personal email accounts.

Educational institutes and non-for-profit organizations: Contact us to see whether your orgainzation qualifies for a free production license (not a trial license).

 
Support E.U. Module 1 specification v1.4.
Support Japanese NIHS eCTD specifications
Support Switzerland/SwissMedic eCTD specifications
Support Taiwanese DoH ESBF M1 eCTD specifications
Support Non-eCTD Electronic Submissions (NeeS) (Desktop Edition only)
Multi-language (Unicode) User Interface Support: English language pack is now available. Language packs for Chinese, French, German, and Japanese will be available on March 1, 2010.
Regulatory Activity View: Related sequences can be grouped together as a Regulatory Activity (unit of approval). Each Regulatory Activity has its own Current and Cumulative Views so you now have the option of focusing on an individual regulatory activity or the entire eCTD dossier.

Study Category View: Group pre-clinical and clinical studies by different Study Tagging File categories (species, route of administration, duration, type of control …etc). You now have new ways to find and view specific studies.

One-click acces to Application Forms and/or Cover Letters right at the Sequence folder level. No need to expand the CTD structure! This allow users to quickly probe a submission before wondering into the forest of eCTD's Table of Contents.
Support Command Line Parameter (Desktop Edition only): When setup correctly, this allows for maintaining submission information in a spreadsheet and launching the eCTD Viewer loaded with an eCTD application or Sequence of your choice right from within spreadsheet (similar to how hyperlinks work). (For enterprise solution for submission tracking with integrated eCTD viewer, check out our ROSETTA Pyramid Regulatory Tracking system.)
Navigate back and forth between linked documents, including linked PDF documents, regardless whether documents are displayed in a PDF reader or inside a web browser. In addition, ROSETTA Phoenix Server and Enterprise Editions support navigation between linked documents stored in Documentum docbases.

Integration with ROSETTA Annotation and Collaboration Service (Sever and Enterprise Editions only, licensed separately): To assist in reviewing and QC process, you can add comments and review notes to submission documents at any levels in the eCTD structure without altering the origional documents.

 
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