OTTOBRUNN, GERMANY--(Marketwire - Sep 4, 2012) - EXTEDO, a key Regulatory Information Management software and service solutions provider for life sciences firms, today announced the availability of a new version of GLOBALvalidator™, an easy-to-use eCTD and NeeS validation solution.
GLOBALvalidator is a comprehensive validation solution that provides life sciences firms with capabilities such as viewing of envelope information, up-to-date FDA validation sets, fast validation, and Q+A36 best practice validation.
The new version of GLOBALvalidator adds support for the following validation sets:
- EU-eCTD 4.1
- EU-NeeS 3.0
- GCC-eCTD 1.0 (Gulf Cooperation Council)
- KSA-NeeS (Kingdom of Saudi Arabia)
The new version of GLOBALvalidator is available now and can be ordered at the EXTEDO online store. The new EU validation sets are also included in the free version EURSvalidator.
"GLOBALvalidator provides life sciences companies with a single solution to validate submissions to all of the leading regulatory authorities," stated Martin Schmid, Managing Director for EXTEDO. "This new version adds support for the six Arab States that are part of the Gulf Cooperation Council as well as NeeS support for Saudi Arabia."
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.
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