EXTEDO Announces Free Download of eCTD Validation Tool
April 13 2010 - 8:16AM
Marketwired
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:
- EU eCTD validation criteria ver. 2.1
- EU NeeS validation criteria ver. 1.0
- CH eCTD validation criteria ver. 1.0
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.
Media Contact: Michael Kane EXTEDO Tel: 1-978-257-2179 Email:
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