June 27, 2012 10:35 ET

EXTEDO Introduces New Member of Submission Reviewing & Validation Family of Products

EXTEDO GLOBALvalidator Combines Capabilities of EURSvalidator and GECCO

OTTOBRUNN, GERMANY--(Marketwire - Jun 27, 2012) - EXTEDO, a key eRegulatory Affairs solutions provider for life sciences firms, today announced the availability GLOBALvalidator™, a new, easy-to-use eCTD validation solution. GLOBALvalidator combines the powerful technologies of EURSvalidator and GECCO.

GLOBALvalidator is available now and comes standard with capabilities such as viewing of envelope information, new FDA validation sets, fast validation, and Q+A36 best practice validation. A complete list of capabilities is available on the EXTEDO website. With the availability of GLOBALvalidator, the GECCO tool will be discontinued.

"GLOBALvalidator ensures that life sciences firms are creating eCTD submissions that are in line with the latest specifications and guidance," stated Tore Bergsteiner, CEO for EXTEDO. "Our product family, which includes EURSvalidator, GLOBALvalidator, and EURS is Yours, provides all of the capabilities required for validating, viewing, and reviewing submissions."


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.

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