eCTD Validator - eSubmission Technical Validation

The purpose of validation is to help ensure Sponsors provide valid electronic transactions and reduce follow-up times to Agency requests. Validation minimizes the possibility of rejection due to technical validation errors which can cause delays in the overall regulatory process.

Prior to filing your eCTD submissions to regulatory agencies you should make certain your sequences are technically valid.

All your usage scenarios are covered:

In-house publishing / QC
You have a team dedicated to publishing eCTD sequences. You also have a team to do Quality Control (QC) and approve documents and sequences before they get sent to Health Authorities.
Use Mono eCTD Validator.
Outsourcing publishing
You receive published sequences. You need to review and check the final result (documents, lifecycle, hyperlinks, ...) before sending to Health Authorities.
Use Mono eCTD Validator.
Consultancy / CRO company
You publish eCTD sequences as a service to pharma companies. You need to provide a validation report to your clients.
Use Mono eCTD Validator.
Local agent
You submit received eCTD sequences to your local Health Authority. You need to double-check if the sequence is complete and valid.
Use Mono eCTD Validator.
eCTD validation for all regions and targeted platforms
You need a simple (powerful and feature rich) and super fast eCTD validation 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 Validator requires no special server components and can be run on any Windows version.

Mono eCTD Validator is a multi-regional eCTD validation solution packed with lots of powerful features to help you provide valid electronic submissions to regulatory agencies.

Mono eCTD Validator (Master edition) is a part of Mono eCTD Office.

Validation Rules - Complexity Friendlified

Mono eCTD Validator was built with the ease of use in mind: the complex list of technical rules is presented in a user friendly manner. Rules are grouped by their category having each rule described with rule severity, description, comments and corrective actions on how to solve a possible problem.

Mono eCTD Validator streamlines the technical review process and ensures compliance with eCTD specifications, guidelines, best practices and regulatory requirements across ICH regions.

Mono eCTD Validator's fluent user interface hosts a rule tree and a set of tabbed panes to quickly preview regional metadata (envelopes / administrative info / transaction info), sequence summary and PDF validation reports.

Most recently validated sequences are kept for faster re-validation. Upon validation the validation summary and the complete validation report (along with partial report - including only rules that failed to met the validation criteria) in PDF format is generated.

eCTD Supported Validation Sets

Mono eCTD Validator can technically check any ICH eCTD submission. Regions supported: US, CA, EU, CH, GCC, JO, AU, TH, ZA.

A validation set is defined by the region, Module 1 version and the technical validation document version.

Mono eCTD Validator automatically detects and selects the correct Validation Set (ICH region, validation and Module 1 version) for the selected sequence to be validated.

In each edition all supported validation sets are available:

Fully supported:
eCTD USA / FDA | CDER and CBER | Validation 4.3 | M1 Version 2.5 | DTD 3.3
eCTD Europe | Validation 7.1 | M1 Version 3.0.4 [any EU country, any submission type or procedure type]
eCTD Switzerland | Validation 1.5 | M1 Version 1.5
eCTD GCC (Gulf Cooperation Council) | Validation 1.4 (/1.2) | M1 Version 1.5 (/1.2)
eCTD Jordan | Validation 1.1 | M1 Version 1.1
Implementation in progress:
Q2/2022 : eCTD Australia | Validation 3.1 | M1 Version 3.1
Q3/2022 : eCTD Canada | Validation 5.0 | M1 Version 2.2
Roadmap:
Q4/2022 : eCTD Thailand | Validation 1.0 | M1 Version 1.0
Q4/2022 : eCTD South Africa | Validation 1.0 | M1 Version 1.0
Q4/2022 : eCTD China | Validation 1.0 | M1 Version 1.0
- ~ -
Q1/2023 : Good Regulatory Practice / Best Practice extended validation sets
Q2/2023 : EU Veterinary NeeS Validation
Q2/2023 : GCC Veterinary NeeS Validation

Active license holders will receive all application updates, for free, as soon as they are released.

Get Your Mono eCTD Validator License

Mono eCTD Validator 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 most features restricted. The Expert edition has some advanced features restricted. The Master edition has no limitations and includes ALL the in-depth features and eCTD validation tools you might need.

Time Limited Promotional Offer
While we are finalizing implementation for the remaining ICH eCTD regions (supported validation sets) - we are running time limited promotional offers.
Make sure to get your license before promo expires. All new future application releases will be provided for free to active subscription license holders.

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

1 year EXPERT subscription
500 €
PROMO 25% OFFER Save 125 € or more.
375 € ($412)
value deal
1 year MASTER subscription
800 €
PROMO 35% OFFER Save 280 € or more.
520 € ($570)
unlimited power
1 year PROFESSIONAL subscription
300 €
PROMO 20% OFFER Save 60 € or more.
240 € ($264)
limited features
* Secure Online Payment
Bigger team? Mono eCTD Office / Mono eCTD Viewer user?
Benefit from extra discount (up to 70%) when purchasing more than 3 licenses.
If you have an active license of Mono eCTD Office or Mono eCTD Viewer - you can opt for even more discount!

Contact Us.

Mono eCTD Validator Editions

Each edition supports validation of all regions and any combination of submission-type, procedure-type or similar, not tied to a specific country. Never mind if you need to validate an EU centralised procedure or a CDER/FDA IND sequence or a Swissmedic Drug Master File: all validation sets are readily available in all editions.

Mono eCTD Validator Edition
BEGINNER
PRO
EXPERT
MASTER
Target Environment
Run on Desktop / Laptop / Remote Connection
Run on Server – single named user
Run on Server – single concurrent user
Run on Server – multiple concurrent users [min 3 licenses]
Run on Server Farms - concurrent users across multiple servers[min 5 licenses]
Super fast validation / All supported regions
Complete Validation Report
Save validation report(s) [as PDF]
Print validation report(s)
Keep tabbed list of validated submissions for faster re-validation
Include Regional Metadata in report
Generate both complete (all rules) and partial (non-success rules) reports
Filter result tree to show only failed rules
Add markup annotations (highlight/sticky note, …) to reports
“Good Regulatory Practice” (/ “Best Practice”) validation rules **
[tool] PDF Hyperlink Explorer
[tool] Submission comparer (compare two [sequence] folders)
Priority Email/VOIP support
** when implemented (Q1/2023).

Mono eCTD Validator Features

Mono eCTD Validator is under constant testing and development. Features you will benefit from:

Your eCTD Validation Solution

Even if you already have an eCTD validation tool: try Mono eCTD Validator to unleash all the potentials of eCTD compliance testing.

Make sure your submissions are not rejected by Regulatory Agencies!

Mono eCTD Validator is a CESP (Common European Submission Portal) approved validation tool.

Your eCTD Validation Solution

Validation Rules Tree

The appropriate validation set is automatically detected and selected by Mono eCTD Validator. Each validation set defines a group of rules as specified by each regional Agency. Rules are defined by their severity (medium, high ... or pass/fail) and their descriptive text and comments and possible how-to-solve actions. The rule validation details tab lists additional entries related to documents that failed to meet the required criteria.

Validation Rules Tree

No time to waste time?

Nobody has seconds (or minutes) to spare. Mono eCTD Validator will unleash your machine processing power. During validation, multiple documents will be processed (validated) at the same time. Have your sequence validated in no time. A 4 GB submission validated in less than 4 seconds!

Multi threading in eCTD Validation

Validation Summary

Your validated sequence at a glance. The Validation Summary provides your starting point to determining if a sequence is valid or not. What's more it lists supplementary data like additional sequences found, sequences referenced, missing sequences. Further: number of files, file types, validation version, ...

Validation Summary

Validation Report: Complete

Upon validation, the complete validation report in PDF format, including results for all validation set rules, is generated. Readily save or print the validation report and send it to your Regulatory Agency or client.

Validation Report: Complete
[Master | Expert]

Validation Report: Partial

If there are rules that failed to meet validation criteria, a partial report will also be generated including only the rules which did not succeed. Quickly scan and easily fix your submission.

Validation Report: Partial
[Master | Expert]

Most Recently Validated

Keep the tabbed list of most recently validated sequences for faster re-validation. Decide what number of items to keep. Each tab hosts the regional image, product name and the sequence number - so you can easily locate the submission you need to re-validate.

Most Recently Validated
[Master]

Markup Annotations (/Comments)

Add markup style annotations to the generated validation report. Speed up your internal reviewing process using standard PDF commenting tools: highlight and sticky note. Add replies, set statuses and open in any PDF viewer.

Markup Annotations
[Master]

PDF Hyperlink Explorer

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!

PDF Hyperlink Explorer
[Master]

Submission Comparer

Use Submission Comparer to determine changes between two eCTD (/NeeS) sequences, pinpoint missing files, alternations in file size or differences in MD5 checksum between same named documents. Filter the compared display to show only the missing documents in the matching structure.

Submission Comparer
Your current validation tool is slow, missing features, has restrictions?
Request to download a trial version of Mono eCTD Validator to unleash all the potentials of eCTD compliance testing.

Contact Us.