The LORENZ eValidator is the most advanced validator on the market, developed in collaboration with regulatory agencies.

eCTD and NeeS Validation

An enormous challenge facing today’s submission specialist is the changing regulatory landscape. As standards evolve, publishers must adapt. Add in the complexity of submitting globally - whererequirements differ from region to region - and that challenge increases dramatically. The answer: the LORENZ eValidator for both eCTD and NeeS validation.

The LORENZ eValidator 3.0

The LORENZ eValidator comes in two versions: a basic version which is available freely for download and a professional pay version.

The LORENZ eValidator was originally designed in 2002 to overcome the problems associated with the different interpretations of the eCTD specifications around the world. It was a first attempt to harmonize the interpretation on a regional basis. LORENZ’ involvement with the EMEA from 2004 - 2006 provided the first official list of validation requirements for the EU.

After LORENZ won the “eReview” contract from Health Canada, it became clear that Canada required far more stringent validation criteria than the European agencies. As a result, the second generation of the eValidator was released in 2007 to meet more comprehensive validation needs. Today’s eValidator (the third generation) not only includes all available eCTD criteria from Health Canada, US FDA, European EMEA and Japanese PMDA, but also the ability to validate NeeS submissions.

The Professional edition of the eValidator also includes a built-in rules editor that allows users to fully customize the validation criteria in a scripting language. The eValidator thus becomes an all-purpose validation tool that can be applied to a variety of e-filing types.

Download E-Validator Brochure

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(source: www.lorenz.cc)