eCTD Lifecycle Viewer Release Announcements

eCTD Lifecycle Viewer 18 March, 2015

Extending Possibilities

eCTD Office's eCTD Lifecycle Viewer is today a mature product used by many companies and pharma individuals.

Here's a list of some of the more recently added new features and improvements:

  • Support for FDA M1 3.3
  • Support for TGA 0.9
  • Support for Swissmedic 1.2
  • Document Viewer navigation (warning when navigating back to a replaced document, for example)
  • Quick preview of document's first page directly from the lifecycle tree
  • User interface customization (to hide UI elements)
  • Regulatory activity view (related sequences)

PDF Hyperlink Explorer

New tool in the eCTD Viewer's toolbox!

Need to explore all hyperlinks between PDF documents sharing a common folder (like an e-submission, eCTD/NeeS sequence folder)? PDF Hyperlink Explorer quickly scans and processes PDF documents and hyperlinks to present a clean and simple view of how your documents are cross-linked.

Check for the type of the hyperlink (including link text, page, position), target documents, whether a document is optimized for Fast Web View, if PDF properties are valid (initial view magnification, initial view page layout, PDF version, etc.).

Process any PDF collection - not only an eCTD/NeeS submission!

eCTD Viewer - PDF Hyperlink Explorer

Even if you already have an eCTD viewing solution - try eCTD Office eCTD Viewer to unleash all the potentials of an eCTD lifecycle!

Installing (the upgrade) takes only a few seconds. All registered users get the upgrade for free, of course.

eCTD Lifecycle Viewer 18 March, 2015
eCTD Lifecycle Viewer 29 March, 2013

Efficiency on Steroids

Two years after the first release eCTD Office's eCTD Viewer again raises the bar.

  • Have submissions where documents are reused (reference / virtual documents) in different sections or even across sequences?
  • Have many PDF documents linking to different sections in an eCTD or even to previous sequences?
  • In an EU/GCC eCTD submission you would like to filter out your custom M1 view by countries involved?
  • Fancy different filtered views (current, cumulative, unlimited custom) easily switchable?

File reuse / Reference leaves / Virtual documents?

The name is not unique but the idea is encouraged by ICH and Agencies: eCTD provides the ability to submit a file once and display it in multiple locations of the eCTD by providing multiple leaf elements referencing that file. The new File Reuse tab visually displays how your submission documents are reused in a sequence or even across sequences. Reviewers or your product, and you, can readily identify files which are referenced multiple times.

Documents linking to other (same sequence or cross-sequence) documents?

You think a study-report.pdf under an M5 section has hyperlinks to a few other documents in the submission? Not sure if this one points to M2 data and if all the hyperlinks are functional? Activate the new Hyperlinks tab and find the answers - visually identify targeted documents in the same or across different sequences.

Reviewing an EU (/GCC) MRP / DCP procedure? More countries involved?

Filtering section now lists all countries involved in the life of a product and you can quickly hide those you are not interested in momentarily.

Current, Cumulative? Boring. How about your own Custom Views?

As unique as you are. Current and cumulative views are ok, but when you need more control you want unlimited number of easily switchable custom views.

eCTD Viewer - Efficiency on Steroids

A picture is worth a thousand words but your real experience is worth a thousand pictures! Do not believe our words and pictures - try for yourself and never look back again!

Even if you already have an eCTD viewing solution - try eCTD Office eCTD Viewer to unleash all the potentials of an eCTD lifecycle!

Installing (the upgrade) takes only a few seconds. All registered users get the upgrade for free, of course.

eCTD Lifecycle Viewer 29 March, 2013
eCTD Lifecycle Viewer 15 October, 2012

Exploration Without Limits

Managing lots of Study Tagging Files (STF) in your (FDA) eCTD submission? Want to view eCTD sequences in your own way?

We've been listening to your requests and have again improved the eCTD Office eCTD Viewer.

Managing lots of Study Tagging Files (STF) in your (FDA) eCTD submission?

The new STF Categories tab will display all your study tagging files grouped using category elements as specified in the STF. This includes: 4.2.3.1 Single dose toxicity (grouped by species and route of administration), 4.2.3.2 Repeat dose toxicity (grouped by species, route of administration, and duration if applicable), 4.2.3.4.1 Long term [carcinogenicity] studies (grouped by species) and 5.3.5.1 Study reports of controlled clinical studies pertinent to the claimed indication (grouped by type of control).

The new Study View will display documents in a selected STF grouped by their file-tag values.

Want to view eCTD sequences in your own way?

Not only can you view your eCTD submission sequences in the "current" or "cumulative" views, you can also specify, and save (to re-apply later), any custom views: a particular sequence, only some modules, specific document operation (new, replace, append, delete). Flagged documents, documents with your custom notes. Mix and match any way you need!

eCTD Viewer - Exploration Without Limits - STF Viewer

Even if you already have an eCTD viewing solution - try eCTD Office eCTD Viewer to unleash all the potentials of an eCTD lifecycle!

Installing (the upgrade) takes only a few seconds. All registered users get the upgrade for free, of course.

eCTD Lifecycle Viewer 15 October, 2012
eCTD Lifecycle Viewer 26 April, 2012

Expand Your Horizons

Running multiple monitors? Looking for PDF hyperlinking information?

Running multiple monitors?

You would like to be able to move the Document Viewer to a different monitor while still being able to analyze envelopes or run advanced searches on your eCTDs?

The Document Viewer now sports the "Undock" button. Undock will make the Document Viewer float on top of the main application window. What's more you can move it to a different monitor and maximize your viewing experience! Close it to dock it again to the main application. As simple as that!

Looking for PDF hyperlinking information?

In an eCTD many documents have links to other documents. You would like to have a simple list of all hyperlinks within a document? A list to tell you where the hyperlinks is, where does it point to?

Activate the “hyperlinks panel” on the Document Viewer and the PDF document will be processed for hyperlinks. Filter for bookmarks, URI style hyperlinks, hyperlinks to other documents and hyperlinks to pages of the same document including full hyperlink information.

eCTD Viewer - Expand Your Horizons

Even if you already have an eCTD viewing solution - try eCTD Office eCTD Viewer to unleash all the potentials of an eCTD lifecycle!

Installing (the upgrade) takes only a few seconds. All registered users get the upgrade for free, of course.

eCTD Lifecycle Viewer 26 April, 2012
eCTD Lifecycle Viewer 28 October, 2012

More Hidden Gems

Why stop your eCTD lifecycle experience at the sequence / document / operation level?

Would you like to quickly find out what sequence replaces sequence 0000 with submission type = "amendment" / "supplemental-data"?

The "Envelope / Admin Elements Analyzer" allows for complex queries to envelope elements - get the info in just a click!

eCTD Viewer - Envelope Analyzer

Even if you already have an eCTD viewing solution - try eCTD Office eCTD Viewer to unleash all the potentials of an eCTD lifecycle!

Installing (the upgrade) takes only a few seconds. All registered users get the upgrade for free, of course.

eCTD Lifecycle Viewer 28 October, 2011
eCTD Lifecycle Viewer 13 June, 2011

Experience Something New

We believe an eCTD viewer should not only allow you to simply view documents in an electronic submission lifecycle.

How about having an option to have custom notes for every document in your electronic submission?

How about being able to also mark a document with a "flag" using custom flag names?

eCTD Viewer lets your transform simple viewing into a more two-way experience. Save (and load) multiple notes per one submission. Share your notes with others in your team!

eCTD Viewer - Experience Something New

Even if you already have an eCTD viewing solution - try eCTD Office eCTD Viewer to unleash all the potentials of an eCTD lifecycle!

Installing (the upgrade) takes only a few seconds. All registered users get the upgrade for free, of course.

eCTD Lifecycle Viewer 13 June, 2011
eCTD Lifecycle Viewer 15 March, 2011

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 - Your eCTD Viewing Solution

eCTD Viewer was build with the easy of use in mind. You do not need to understand the complex XML "behind" an eCTD submission.

  • 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).
  • Leaf flagging (mark a leaf with a red/green/blue/orange/magenta/yellow/black flag).
  • Filter for flagged leaves.
  • Save / load leaf flagging states.
  • Lifecycle report.
  • Display XML for the selected sequence in "Sequence" tab.
  • "Reset" button on the "Advanced search" tab to reset search fields to their default state.
  • "Contains" / "Starts with" search options for "Title", "File name" and "ID" fields on the "Advanced search" tab.
  • "Document Viewer" - takes advantage of the pdf plug-in for your Browser (IE)
  • - supports PDF hyperlink navigation.
  • - supports STF (study tagging file) preview.
  • Save screen layouts (to quickly reconfigure screen UI).
  • Basic document info (title, sequence, target) above the preview.
  • Configuration to set common options
  • "Only Study Tagging Files (stf-*.xml)" search option on the "Advanced search" tab.
  • 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!

eCTD Lifecycle Viewer 15 March, 2011