eCTD Lifecycle Viewer

Mono eCTD Viewer streamlines review process, reduces response times to Agency requests, and ensures faster approvals for your products.

What is your usage scenario?

In-house/service publishing
A team dedicated to creation of eCTD sequences. You need to do Quality Control (QC) and approve documents and sequences before they get sent to Health Authorities.
You publish eCTD sequences as a service to pharma companies. You need to allow your clients to see the results before final approval. Use Mono eCTD Viewer.
Outsourcing publishing
Receiving published sequences from your publisher.
You need to review and check the final result (documents, lifecycle, hyperlinks, attributes, regional metadata ...) before sending to Health Authorities. Use Mono eCTD Viewer.

Trying to use Edge, Chrome or Internet Explorer (IE) to view eCTD backbones?

Internet Explorer is no longer supported and trying to use a Browser to navigate eCTD's XML backbones could be cumbersome. You need a true eCTD navigation and reviewing system.
Run Anywhere. View It All.
Mono eCTD Viewer is a simple (powerful, customizable and feature rich) and super fast eCTD reviewing system, covering all ICH eCTD regions and submission/procedure types, to be used on your laptop, desktop, terminal server, Citrix, using Remote Desktop Connection, or somewhere in the Cloud. Mono eCTD Viewer requires no special server components and can be run on any Windows version.

Sequence / Current / Cumulative?

Mono eCTD Viewer was built with the ease of use in mind: the complex XML eCTD (Electronic Common Technical Document) structure of an eCTD lifecycle is presented in a user friendly manner.

Mono eCTD Viewer's fluent user interface hosts a filter pane, a backbone tree (including current, cumulative and custom views) and a set of tabbed panes to quickly preview documents, metadata attributes, envelopes (regional information), lifecycle info, STFs, PDF hyperlinks, etc. Can be easily configured to match your (client) needs.

To load a lifecycle, eCTD sequences (documents and folders) need to be available through the file system (local drive or network shared drives).

Mono eCTD Viewer's user interface is available in multiple languages (English, Dutch, French, German, Spanish, Italian).

Mono eCTD Viewer can load and process any eCTD submission, as long as sequences conform to ICH and regional eCTD specifications: US, CA, EU, CH, GCC, JO, AU, TH, ZA, CN .... eCTD submissions.

Get Your Mono eCTD Viewer License

Mono eCTD Viewer is available in four editions: Beginner, Professional, Expert and Master. The Beginner edition is FREE and has most limitations and none of extra tools. The Proffesional edition has some features restricted. The Expert edition includes most of the features and eCTD lifecycle tools. The Master edition has no restrictions and includes ALL the in-depth features and eCTD lifecycle tools you might need.

Ready to try the free Beginner edition? Request your free copy. Ready to unleash all your potentials? Purchase your license:

1 year
EXPERT
subscription
1 year
MASTER
subscription
550 €
($559)
annually/computer
most wanted
1 year
PROFESSIONAL
subscription
* Secure Online Payment

Need more? Benefit from extra discount (up to 50%) when purchasing more than 5 licenses. Contact Us.

Mono eCTD Viewer Editions

Mono eCTD Viewer is a multi-regional eCTD re-viewing solution packed with lots of powerful features to help you explore and understand eCTD product's lifecycle more easily. Are you a beginner or an eCTD lifecycle master?

Mono eCTD Viewer Edition
BEGINNER
PRO
EXPERT
MASTER
Target Environment
Run on Desktop / Laptop
Run on Server/Remote Connection – single named user
Run on Server/Remote Connection – single concurrent user
Run on Server/Remote Connection – multiple concurrent users [min 3 licenses]
Run on Server Farms - concurrent users across multiple servers[min 5 licenses]
Load and process all sequences of an eCTD product
Up to 0004
Load up to specified sequence
Up to 0004
Load multiple eCTD submissions (tabbed UI)
Only 1
Only 1
Filter any view by document “has markup”
Unlimited advanced document(s) content search results
Up to 5
Up to 5
Multiple advanced metadata document searches
Only 1
Only 1
Multiple regional metadata search options
Only 1
Only 1
Load only last X sequences (up to specified)
Load only selected modules [m1, m2, m3, m4, m5]
Save and re-apply custom view filters
Save (any view) lifecycle as CSV
Save regional metadata as CSV
Save / load and share unlimited document flagging states
Up to 5
Up to 10
Save / load and share unlimited document notes
Up to 5
Up to 10
[tool] Submission comparer (compare two [sequence] folders)
Print (any view) lifecycle structure
Filter STF's by categories and values
Priority Email support
Priority VOIP support
Click to expand common features »

Mono eCTD Viewer Features

Mono eCTD Viewer is under constant testing and development: new features, as a result of user requests, are being added daily. Check out some of the more exclusive features you can benefit from:

Your eCTD Viewing Solution

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

Using additional tools included like MD5 Fixer, PDF Hyperlink Explorer, Submission Comparer you can understand your e-submissions more deeply.

Advanced keyword in-depth search
[Master]

XPT Viewer in Document Viewer

Lots of electronic datatasets in your submission? Having trouble viewing data in XPT (SAS XPORT Transport) files?

XPT Viewer quickly parses XPT datasets and present all Members including all Observations per Member, in a tabular format.

Readily check if the study start date is defined. Make sure StudyID (or SPREFID) matches STF's Study ID.

Flagging and notes in eCTD Viewer
[Master | Expert]

Two-way Experience

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 add 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!

[Master]

Global Modules / CTD Sections Filter

While the Current, Cumulative and Sequence views would display all (included) CTD sections by default - if you need to quickly check only M1 or M3 or even only sections including literature references - the handy global CTD sections filtering rests above all views. You are one click of a button away from looking at only what you are interested in.

Decide to display only a specific module: M1, M2, M3, M4, M5. Or, make visible only specific CTD sections: "Quality" (M2.3, M3), "Non-Clinical" (M2.4, M2.6, M4), "Clinical" (M2.5, M2.7, M5) or "Literature References" (M2.7.5, M3.3, M4.3, M5.4.)

STF display and filtering in eCTD Viewer

Lots of STFs in your (FDA) eCTD submission?

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).

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

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. 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.

Standard features

  • Current / cumulative / sequence / regulatory activity / custom views.
  • Clear presentation of submission metadata, such as indication, dosage form, manufacturer, excipient.
  • Visual indicators for lifecycle leaf operations (new, append, replace, delete).
  • Display of append documents under their "parent" / original document with implicit delete operations.
  • Metadata attribute viewer.
  • Load a document in embedded PDF viewer, external PDF viewer or just locate in Windows Explorer.
  • Save screen layouts (to quickly reconfigure screen UI).
  • Basic document info (title, sequence, target) above the preview.
  • Compare two sequences (or any two folder structures).
  • Leaf flagging (mark a leaf with a different flag).
  • Save and re-apply filters: by module, by sequence, by leaf operation, by title, by target sequence, by file name, by leaf ID, ....
  • Multilingual user interface (English, Dutch, French, German, Spanish).
  • Load lifecycle (from a specific) up to specific sequence.
  • Lifecycle report.
  • Save regional metadata as CSV.
  • Save current view as CSV.
  • Save STF/Study View as CSV.
We speak your language

Speaks Your Language!

Not fluent in English? No problem!

Parlez-Vous Francais? Sprechen sie Deutsch? ¿Habla español? Spreekt u Nederlands? Parli italiano?

Have the user interface translated to the language you know in one click and on-the-fly!

eCTD Products Repository

Products Repository serves as your starting point into exploring and navigating all your eCTD products. Displayed upon startup it will automatically pick any newly generated and available sequences of your products detailing number of available sequences when published and displaying regional metadata. Open any product in eCTD Viewer or validate in Mono eCTD Validator.

Markup annotations
[Master]

Markup Annotations (/Comments)

Want to comment on sequence documents? How about adding/editing and viewing PDF style markup annotations? Speed up your internal reviewing process using standard PDF markup tools: highlight, insert-text, replace-text, strikeout-text, sticky note, pop-up note, text box. Add replies, set statuses.

Easily summarize all the comments in the document - summary can be presented in various ways.

Don't worry! Markup is stored in a separate file -> your documents (and backbones) are not altered in any way! What's more, you can also markup your non-PDF documents.

Compare documents
[Master*]

Compare documents

Quickly identify changes by comparing two versions of a submitted document: the lifecycle replacement and the 'original'. Content (text, formatting, etc.) changes in documents are analyzed and a side-by-side comparison document detailing differences is generated. The comparison tool lets you apply filters to see what has been changed: text, formatting, annotations, images or header and footer.

Combine documents
[Master*]

Combine documents

Easily combine (/merge) all documents in the active view (current, cumulative, sequence, custom) into a single (or per Module) PDF document. TOC is created along with bookmarks for easier navigation.

Multiple Configurations Sets
[Master]

Multiple Configuration Sets

How complex or simple do you want the user interface to be? Are you interested only in documents and their lifecycle? Or, are you only interested in Study Tagging Files (STF)? Would you like to go to the last sequence directly after loading the lifecycle? What's your preference: Current or Cumulative or Sequence view as default? And how do you want them ordered?

What's your role? A RegOps member? Or QC is what you need to do? Want to pretend you are the Reviewer at the Agency?

Have unlimited number of configurations saved - and quickly, on-the-fly, apply to change your needed role.

[Master]

MD5 Checksum Fixer

You need to do just a little edit to your cover letter or the application form? You noted just one link is missing in your responses document? A few leaf titles would need to be slightly updated? If you do any such change your submission will become invalid! The backbone files (index.xml and cc-regional.xml) store the checksum (MD5) of each document that is a part of your sequence - if you do any changes you will experience the "wrong checksum in index-md5.txt" error with eCTD validators.

Don't worry! The "Backbones MD5 Checksum Fixer" tool will quickly re-scan all your documents and update the "checksum" attribute in backbones files and the index-md5.txt.

Filtering in eCTD Viewer

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 tailored (savable) views.
Display only one sequence or all sequences in a regulatory activity.
Have 2.3.S, 2.3.P, 3.2.S, 3.2.P sections (drug substance, drug product, dosage form, manufacturer, indication) merged into and displayed as a single section collecting all documents - to more easily navigate to and compare documents across different branches.

Regional info in eCTD Viewer

Envelope/Regional Elements Analyzer

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.

Cross linking PDFs in eCTD Viewer

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 Hyperlinks tab and find the answers - visually identify targeted documents in the same or across different sequences.

Fluent & Streamlined User Interface

Are you only interested in viewing eCTD lifecycle documents or is having the ability to drill down an eCTD what drives you?

You can easily configure what elements of the user interface are available to you (your reviewers). Make eCTD Viewer super basic or have its full potential at your fingerprints.

Document Viewer sports the "Undock" button. Undock will make 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.