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

03/15/2011 Blue arrow Release Announcement: FREE eCTD Viewer - Your eCTD Viewing Solution.

Author: zarko
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.
Rated 5.00, 1 vote(s). 

10/20/2010 Blue arrow Release Announcement: eCTD Office - The Best(*) Just Got Better!

Author: denis
Mono Software and PRS today announced the major new release of the eCTD Office Suite, a widely used NeeS / VNeeS / eCTD publishing system for EU and Swissmedic eCTD / NeeS electronic submissions. Learn more about the new features included in this release...
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07/01/2010 Blue arrow Release Announcement: eCTD Office - Full Support for Swiss eCTD Version 1.1

Author: zarko
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.
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05/18/2010 Blue arrow Release Announcement: eChecker - FREE VNeeS Validation Tool

Author: zarko
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.
Rated 3.00, 1 vote(s). 

04/08/2010 Blue arrow How much did you pay for your eSubmission solution?

Author: zarko
eCTD Office from Mono Software LTD is a suite of integrated NeeS / VNeeS / eCTD software products for the creation, validation, viewing, manipulation and archiving of NeeS / eCTD submissions. eCTD Office applications are being used by pharma companies and pharmaceutical consultancy companies all over Europe (France, The Netherlands, Belgium, Spain, Czech Republic, Germany, UK, Bulgaria, Ireland, Norway, Cyprus, Malta, Latvia, Lithuania, Sweden, Austria, Finland, Poland, Greece, Estonia ...)

For a limited time period you can order a 1 Year New User License of the NeeS Compiler tool for only 2000 €.

NeeS Compiler s a next generation off-the-shelf Windows software application for building error-free non-eCTD electronic submissions. NeeS Compiler provides tools for quick and intuitive construction of complex, valid non-eCTD electronic submissions.

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