eCTD Lifecycle Viewer

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

Is your usage scenario covered? [If not, let us know :)]

  • You do in-house publishing - you have a team dedicated to publishing eCTD sequences. You also have a (could be the same) team to do Quality Control (QC) and approve documents and sequences before they get sent to Health Authorities. Use Mono eCTD Viewer.
  • You outsource publishing - you need to review and check the final result (documents, lifecycle, hyperlinks, ...) before sending to Health Authorities. Use Mono eCTD Viewer.
  • You are a consultancy / CRO company - 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.
  • You are a local agent - you submit received eCTD sequences to your local health authority. You need to check if the sequence is complete and valid. Use Mono eCTD Viewer.
  • You need a simple (but feature rich) and fast eCTD (re-)viewing system? To be used on your laptop, desktop, terminal server, Citrix, somewhere in the Cloud? Use Mono eCTD Viewer.

Sequence / Current / Cumulative?

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 .... eCTD submissions.

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 requires no special server components and can be run on any Windows version. Runs on laptops, desktops or server and cloud environments.

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 Professional 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
400 € ($439) annually/computer
value deal
1 year MASTER subscription
500 € ($539) annually/computer
unlimited power
1 year PROFESSIONAL subscription
300 € ($329) annually/computer
limited features
* Secure Online Payment | * Expert edition formerly called "Architect" (no change in features).

Need more? Benefit from extra discount (up to 60%) when purchasing more than 10 licences. 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 a product
Up to 0004
Load up to specified sequence
Up to 0004
Load multiple eCTD submissions (tabbed UI)
Only 1
Only 1
Combine all documents in active view (current, cumulative, sequence, custom) into a single PDF document
Single sequence
Single sequence
Single sequence
[tool] Backbones (index.xml and regional.xml) MD5 Fixer
Save and quickly apply multiple configuration sets
Global Modules / CTD Section filters in all Views
Fast in-depth PDF keyword search in [sequence] folders
Fast PDF content keyword search in active view (Current, Cumulative, Sequence, Custom)
Add/edit/view markup annotations (/comments) on (pdf) documents
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] PDF Hyperlink Explorer
[tool] NeeS, VNeeS and other electronic dossier formats viewer
[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:

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.