NeeS / VNeeS / eCTD N E W S
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 (enjoying "stellar support") for years: 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...
Release Announcement: eCTD Office September 2011 - New eCTD 3.1 / NeeS 2.1 Validation Fully Supported
Mono Software and PRS today announced the major new release of the eCTD Office suite, widely used NeeS / VNeeS / eCTD publishing system for EU, Swissmedic and Australia (TGA) eCTD / VNeeS / NeeS electronic submissions.
eCTD Office in the latest version includes the following new features:
- Full support for NeeS 2.1 validation criteria.
- Full support for eCTD 3.1 validation criteria.
- NeeS submission publishing for the TGA (Australia)
- Most recently used compilations with customs notes.
- Completely revamped (module) tree searching functionality.
- (Module) tree filtering empowered with actions and leaf flagging.
- Screen Layouts - to quickly reconfigure eCTD Office UI to better reflect your current tasks.
- Various enhancements to make your valid e-submission publishing more user friendly, easier and faster.
Invest only 45 minutes of your time and request a live personalized web demo of eCTD Office.
Release Announcement: FREE eCTD Viewer - Your eCTD Viewing Solution.
Mono Software and PRS today announced the release of the FREE eCTD Office eCTD Viewer - 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.
eCTD Viewer reduces review times, increases response times to Agency requests, and ensures faster approvals for your products.
eCTD Viewer was build with the easy of use in mind. You do not need to understand the complex XML "behind" an eCTD submission.
A list of some of the features built into eCTD Viewer:
- clear presentation of submission metadata, such as indication, dosage form, manufacturer, excipient.
- visual indicators for lifecycle leaf operations (new, append, replace, delete).
- per sequence envelope viewer.
- current / cumulative view.
- metadata attribute viewer.
- save and re-apply filters: by module, by sequence, by leaf operation, by title, by target sequence, by file name, by leaf ID, ....
- open more than one lifecycle in a tabbed user interface.
- load a document in embedded PDF viewer, external PDF viewer or just locate in Windows Explorer.
- compare two sequences (or any two folder structures).
- and more...
Even if you already have an eCTD viewing solution - try eCTD Office eCTD Viewer to unleash all the potentials of an eCTD lifecycle!
TIGes Released New Validation Criteria for eCTD (3.0) and NeeS (2.0).
The new validation criteria will come into force 1 September 2011 and be used for the technical validation for electronic submissions received from that day to the NCAs and EMA. The old criteria should no longer apply from that day.
The previous eCTD / NeeS criteria used a priority scale from A to C to categorise the severity of the issue. The decision was made to move to categorising criteria as Pass/Fail and so-called Best Practice.
With new criteria in force, the applicant should make every effort to address P/F and BP before the electronic submission is submitted to the authority. All P/F criteria have to be fulfilled. If any BP criterion is not met it should normally be explained in the cover letter or reviewer's guide.
New criteria, implementation info, release notes:
Even if you already have an eCTD/NeeS solution, why not take a look at eCTD Office and save on time/money with your next e-submission. We'll take only 45 minutes of your time with a web demo of eCTD Office.
Release Announcement: eCTD Office - Your Publishing Solution!(*)
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 Swissmedic eCTD / VNeeS / NeeS electronic submissions.
eCTD Office in its latest version includes the following new features:
- Support for Croatian National eCTD/NeeS submissions.
- Convert non-PDF documents to PDF at export {example: use a MS Word DOC for a leaf and have it converted to PDF at export}.
- Undoable actions. Need to go step back in your work? No problem!
- Sequence shift. Start your LCM from sequences > 0000.
- Shortcut keys for most common actions.
- VNeeS Compiler - full compliance with Belgian VNeeS Checker.
- Various enhancements to make your valid e-submission publishing more user friendly, easier and faster.
Even if you already have an eCTD/NeeS solution, why not take a look at eCTD Office and save on time/money with your next e-submission. We'll take only 45 minutes of your time with a web demo of eCTD Office.
(*) eCTD Office users are involved in new releases by suggesting new feeatures and imporvements to make eCTD Office even more user friendly and faster in submission publishing.
Announcement: eCTD Office Partner Program
We are pleased to announce that we recently launched a new initiative called the eCTD Office Partner Program. Trusted by hundreds of users, eCTD Office is a widely used NeeS/eCTD publishing system. With the continuous demand for eCTD office, we are looking for partners to expand eCTD Office's presence and support around the world.
The eCTD Office Partner Program offers you all the advantages of a direct and dedicated relationship with eCTD Office vendors toward a goal of satisfied customers and increased sales and profits.
We are seeking individuals and companies like yours to expand eCTD Office's presence around the world, grow the satisfied user base, and make our products more accessible to those customers who want the best possible solutions for their life science e-submission needs.
As a partner, you will be able to:
- Promote eCTD Office and earn up to 40% commission on the resulting sales,
- Add (consultancy, training) services and gain 100% of the income,
- Boost your sales and profits.
Release Announcement: eCTD Office - The Best(*) Just Got Better!
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 Swissmedic eCTD / NeeS electronic
submissions.
eCTD Office in its latest version includes the following new features:
- New and improved embedded PDF viewer with page extraction features. Feels like your common PDF viewer on steroids. (External PDF viewer not required).
- Faster PDF specific embeded validation (broken links, version, linearization, ...)
- More user friendly validation results: "pass" / "fail" and "best practice" warnings.
- One-Click-Import of an existing e-submission (or arbitrary folder structure). Merge an existing NeeS/eCTD submission into your compilation.
- New export option: "Remove invalid PDF web links (www / email)". Not only will eCTD Office fix your valid PDF links, it will also remove any invalid links upon export.
- Various enhancements and new features to make your e-submission publishing more user friendly, easier and faster.
Even if you already have an eCTD/NeeS solution, why not take a look at eCTD Office and save on time/money with your next e-submission. We'll take only 45 minutes of your time with a web demo of eCTD Office.
(*) This is what we get told by our users when ease of use, support and time/price to a published e-dossier is in question :)
Release Announcement: eCTD Office - Full Support for Swiss eCTD Version 1.1
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 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.
VNeeS (Veterinary eSubmission) Compiler Released!
VNeeS Compiler, a part of eCTD Office, is a next generation off-the-shelf Windows software application for building error-free eSubmission for Veterinary Applications.
VNeeS Compiler follows guideline on the specifications for provision of an electronic submission (e submission) for a veterinary medicinal product published by EMEA (TIGes-Vet).
Swiss / CH eCTD Compiler Released!
Swiss / CH eCTD Compiler, a apart of eCTD Office, is a next generation off-the-shelf eCTD (Electronic Common Technical Document) validation, creation, viewing, manipulation and archiving system for Swiss electronic submissions. The main functionality of the Swiss eCTD Compiler is the creation of the eCTD XML backbone (+ envelope data) along with the lifecycle management.
Announcement: Swiss Module 1 Specification in eCTD Office
During the coming months eCTD Office will be extended to support the creation of eCTD submissions for the Swiss Agency for Therapeutic
Products (Swissmedic).
MRP/DCP Tracking Table Builder added to eCTD Office
MRP/DCP Tracking Table Builder, a part of eCTD Office, is a visual Tracking Table XML builder to be used in the context of Mutual Recognition and Decentralised Procedures, under the Module 1 of the electronic Common Technical Document (eCTD) for the European Union (EU).