Knowledge is power. We love to share it.

News related to Mono products, services and latest developments in our community.

zarko

Release Announcement: FREE eCTD Viewer - Your eCTD Viewing Solution.

03/15/2011 By zarko 0
Rated 3.00, 2 vote(s). 
Bookmark and Share
eCTD Office eCTD Viewer is a FREE, stand-alone, super-fast, easy to use Windows desktop application for viewing and understanding the granularity and the lifecycle of electronic submissions prepared in the eCTD (Electronic Common Technical Document) format.
zarko

Release Announcement: eCTD Office - Full Support for Swiss eCTD Version 1.1

07/01/2010 By zarko 0
This content has not been rated yet. 
Bookmark and Share
Mono Software and PRS today announced the major new release of the eCTD Office Suite, widely used NeeS / VNeeS / eCTD publishing system for EU and Swiss eCTD / NeeS electronic submissions.

eCTD Office is a suite of integrated NeeS / VNeeS/ eCTD software products for the creation, validation, viewing, manipulation and archiving of NeeS / eCTD submissions of regulatory documentation by pharmaceutical companies to the regulatory authorities.


eCTD Office in its latest version includes the following new features:
  • Full support for Swiss Module 1 Specification for eCTD, Version 1.1.
  • eCTD Envelope Explorer.
  • Templated Compiler.
  • Various enhancements and new features to make your esubmission publishing more user friendly, easier and faster.
zarko

Release Announcement: eChecker - FREE VNeeS Validation Tool

05/18/2010 By zarko 0
Rated 1.67, 3 vote(s). 
Bookmark and Share
Mono Software and PRS today announced the release of the first VNeeS (veterinary e-submission) validation tool: eChecker. 

eCTD Office eChecker (VNeeS Validator) is a super fast and accurate, off-the-shelf veterinary electronic submissions (VNeeS) validation system. eCTD Office eChecker allows for import of the VNeeS folder / file structure to report whether the structure conforms to the VNeeS format (immunological or pharmaceutical).


eChecker was built on top of the specifications published in the "Guideline on the specifications for provision of an electronic submission (e submission) for a veterinary medicinal product" - published and maintained by the TIGes-Vet.

eCTD Office is a suite of integrated NeeS / VNeeS / eCTD software products for the creation, validation, viewing, manipulation and archiving of NeeS / VNeeS / eCTD submissions of regulatory documentation by pharmaceutical companies to the regulatory authorities.