Release Announcement: Full Support for US FDA eCTD (Including STF Builder) - January 2012
Mono Software and PRS today announced the major new release of the eCTD Office suite, widely used eCTD (NeeS / VNeeS) publishing solution for EU, US (FDA), CH (Swissmedic) and Australia (TGA) eCTD / NeeS / VNeeS electronic submissions.
The wait is over!
Finally, companies preparing e-submissions for FDA (U.S. Food And Drug Administration) can benefit from the easy-to-use, affordable, feature packed tool many EU located companies are using for years (enjoying "stellar support"): eCTD Office!
eCTD Office in the first 2012 release includes the following new features:
- Full support for US (FDA) eCTD submissions (including STF Builder).
- Speed up (up to 75%) in validation, publishing.
- Importing of Envelopes (Admin elements).
- PDF hyperlink (outlines, annotations) correction and fixing.
- Validation results grouping/sorting by item/type.
- ... and many more improvements...
eCTD Office is not only a publishing solution for your e-submission tasks.
Various tools included in the package ensure your work continues flawlessly:
- Compilers: US eCTD, EU eCTD, EU NeeS, EU VNeeS, CH eCTD, AU eCTD, AU NeeS, HR NeeS, HR eCTD.
- eCTD Lifecycle Viewer / Explorer.
- PDF Hyperlink Fixer.
- Templated Compiler (publish arbitrary structure e-submissions).
- Tracking Table Builder (EU MRP/DCP procedures).
- eCTD Envelope Analyzer, Dosage Forms Browser.
- Submission Comparer.
- Document Manager with PDF optimization.
- and more...
Even if you already have an eCTD/NeeS/VNeeS solution, why not take a look at eCTD Office and save on time/money with your next e-submission.
Invest only 45 minutes of your time and request a live personalized web demo of eCTD Office.