Ensure compliance with regulatory requirements worldwide

Up-to-date: Latest validation sets provided in timely manner

Validation technology trusted by over 35 regulatory authorities globally

Sending non-compliant submissions causes unnecessary delays.

Your submissions may have passed validation internally, but when they fail at the regulatory agency, fixing issues can be time-consuming.

  • I am uncertain about regional variations in submission standards
  • I can’t trust the results from our existing internal validation tools
  • I am unsure why my submission was invalid or how to fix it
  • I get overwhelmed by ever-changing global submission requirements
blob-man-standing-laptop

How we solve the problem

 Most accurate eCTD & NeeS validator

EURSvalidator ensures the highest possible accuracy when validating your eCTD and NeeS submissions. It is used by over 35 regulatory authorities worldwide to validate incoming submissions.

 Up-to-date validation sets - guaranteed

EXTEDO works closely with regulatory authorities worldwide.
We guarantee that all relevant validation sets are included in each regional package and that validation sets are always up-to-date.

 Validate multiple submissions simultaneously

Start the validation of all pending dossiers simultaneously. All pending dossiers and submissions that have not yet been validated will be validated simultaneously.

 Regional validation packages

Regional subscriptions are available, including validation sets for the country or region you want to file your submission within.
Different validation set packages can be combined within a single subscription. 

Consulting 2
EXTEDO builds the bridge between agencies and industry. Get the validation technology that regulatory agencies use.
"EXTEDO is a great example of a company that really understands the requirements of the market."
Director Business Development, Technical Operations and International Business at Genericon

Request your personal EXTEDO Software Demo now!

Your plan to effortless compliance

Video Icon - 500 x 500
1

See how it works

Watch the product video and see how to simplify validation of your regulatory submissions.

consultation-rev
2

Get a quote

Provide us with information about your validation needs, and we will send you a personalized offer.

rocket-rev
3

Pass validation

Relax as your submissions pass agency technical validation first time. 

Make regulatory submissions to authorities around the world without the worry of technical errors

Validating that electronic submissions are compliant with regulatory technical standards worldwide can be complex without a reliable tool.
As the validation tool used by the authorities, EURSvalidator ensures compliance first time, speeding up your submission processes and getting your products to market faster.

Image2

Some of our Customers

BAVARIAN NORDIC
MPA Swedish Medical Products Agency
DANISH HEALTH AUTHORITY
BeiGene
Malta Medicines Authority

Contact us

Resources

EXTEDO_EURSvalidator_Product_Information
Product Information

EXTEDO EURSvalidator Product Information

EURS 8.0 and EURSvalidator 23.10– Supported Validation Sets and Functionality
Product Information

EXTEDO EURSvalidator Supported Validation Sets

EXTEDO RIMS Whitepaper
White paper

RIM Systems - A Catalyst for Technological Innovation