SOURCE: EXTEDO

August 18, 2011 09:27 ET

EXTEDO Announces EURSvalidator 2.0 SP1

New Version of eCTD Validation Tool Features Redesigned User Interface, New Online Help, and CITRIX Support

OTTOBRUNN, GERMANY--(Marketwire - Aug 18, 2011) - 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 VMD, can be downloaded for free at the EXTEDO website.

Version 2.0 SP1 includes a new Graphical User Interface (GUI), faster automatic validation set detection, new ways to add new sequences, parallel mass validation support, improved online help, CITRIX support, and enhanced reporting functionality.

EURSvalidator 2.0 SP1 is integrated into the EURS is Yours™ solution, which is being used by more than 25 regulatory authorities worldwide. It is also integrated into EXTEDO's widely-used submission management system eCTDmanager™. Using EURSvalidator 2.0 SP1 in advance of submitting electronic submissions minimizes the risk of failing technical validation at the regulatory authorities and ensures an improved electronic dossier lifecycle for the future.

EXTEDO recently hosted a webinar that provided information on the new European Union (EU) validation criteria and featured a demonstration of EURSvalidator 2.0 SP1. A replay of the webinar is available here.

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 2.0 SP1 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, version 1.4, and version 3.1)
    with Validation Criteria v2.1 and v3.1

  • EU NEES (Specification version 1.0 and version 2.1)
    with Validation Criteria v1.0 and 2.1

  • 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 2.0 SP1 click here and follow the instructions.

"This is a major release of EURSvalidator," said Tore Bergsteiner, CEO for EXTEDO. "The success of the electronic drug approval process in Europe is primarily based on well-defined and harmonized validation criteria. We continue to support this mission with EURSvalidator 2.0."

About EXTEDO

EXTEDO is the key software and service solutions provider in the field of Regulatory Information Management. The complete EXTEDOsuite is unique in all that it covers within eRegulatory Affairs: Product Registration Planning & Tracking, Submission Management, Pharmacovigilance Management, Labeling 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 one of the worldwide leaders 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.

Contact Information

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