EXTEDO Announces New Version of eCTD Validation Tool
November 29 2010 - 8:00AM
Marketwired
EXTEDO, a key eRegulatory Affairs solutions provider for life
sciences firms, today announced that a new version of
EURSvalidator, a validation tool for eCTD, NeeS, and eNTA can be
downloaded for free at the new EXTEDO website. The new version
includes validation rule sets for the FDA, Croatia and veterinary
submissions. An enhanced reporting capability in the new version
allows users to sort validation results.
EURSvalidator 1.5 is integrated into the EURS is Yours™
solution, which is being used by more than 25 regulatory
authorities worldwide. Using EURSvalidator 1.5 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.
EURSvalidator 1.5 supports the following formats:
- CH eCTD (DTD version 1.0, version 1.0.1, and version 1.1)
- EU eCTD (DTD version 1.2.1, version 1.3, and version 1.4)
- EU NEES (Specification version 1.0)
- HR eCTD (DTD version 1.4)
- HR NEES
- US eCTD (DTD version 2.01)
- Veterinary eNTA immunological product (DTD 0.9)
- Veterinary eNTA pharmaceutical product (DTD 0.9)
To download and install EURSvalidator 1.5 click here and follow
the instructions.
"We have made some significant enhancements to this new version
of EURSvalidator," said Tore Bergsteiner, CEO for EXTEDO. "The
version that is available on our website for users to download at
no charge uses the same validation engine used by most of the
European regulatory authorities. The latest version not only
upgrades the number of supported countries, it also includes a
veterinary rule set that opens up a new area of coverage."
About EXTEDO
EXTEDO is the key solutions and services provider in the field
of eRegulatory Affairs. The complete EXTEDOsuite is unique in all
that it covers: Product Registration Planning & Tracking,
Submission Management, Pharmacovigilance Management, Labelling
Management, and Document Management.
EXTEDO provides configurable off-the-shelf products, as well as
customized and integrated solutions. EXTEDO also provides EURS is
Yours, the validation, review and approval system for the EMA and
more than 25 Regulatory Authorities worldwide.
Today EXTEDO serves more than 700 customers in 57 countries
ranging from small companies with less than 25 employees to large
multi-national organizations. EXTEDO operates in the following
markets for human, veterinary and crop protection: Life sciences,
including pharmaceutical, biotech and biopharma, generics,
homeopathics and medical devices, healthcare, and public sector.
EXTEDO is recognized as the worldwide leader in each of its areas
of operation.
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:
Email Contact