SOURCE: EXTEDO

EXTEDO

April 13, 2010 08:16 ET

EXTEDO Announces Free Download of eCTD Validation Tool

EURSvalidator Used by Over 25 Regulatory Agencies

MUNICH, GERMANY and OTTOBRUNN, GERMANY--(Marketwire - April 13, 2010) -  EXTEDO, a key e-Regulatory Affairs solutions provider for life sciences firms, today announced that EURSvalidator, a validation tool for eCTD and NeeS, can be downloaded for free at the EXTEDO website.

EURSvalidator is integrated into the EURS is Yours™ solution, which is being used by more than 25 regulatory authorities. Using EURSvalidator in advance of submitting electronic submissions minimizes the risk of failing technical validation at the regulatory authorities.

The complexity of submitting electronic dossiers in Europe is unique across the ICH regions, and can only be managed efficiently by providing clear and automated validation criteria.

The EURSvalidator complies with the following validation criteria:

To download and install EURSvalidator please go to http://www.extedo.com/register-for-downloads.html and follow the instructions.

"European regulators have been complaining about the quality of electronic submissions according to the current validation criteria," said Tore Bergsteiner, Managing Director for EXTEDO. "We are proud to be directly supporting the improvement of submissions quality for eCTD and NeeS in Europe by providing our standard tool EURSvalidator™ to applicants at no charge."

For more information please visit: www.extedo.com.

About EXTEDO

For nearly 15 years EXTEDO has been a key services and solutions provider in the field of regulatory data and document management (CTD, eCTD and other formats) for Life Sciences industries and authorities (Pharmaceutical, Crop Science, Chemicals). Based on well-founded expertise and many years of experience, EXTEDO provides highly standardized as well as customized solutions in the area of electronic Regulatory Affairs.

EXTEDO, being globally represented, serves more than 700 Life Sciences organizations in more than 57 countries.

For more information visit www.extedo.com.

All trade names, trademarks, and service marks are the rightful property of their respective owners.

Contact Information

  • Media Contact:
    Michael Kane
    EXTEDO
    Tel: 1-978-257-2179
    Email: Email Contact