eCTD and NeeS Submission Validation Software Solutions
EXTEDO is the only vendor on the market that is able to cover the complete regulatory landscape, including Product Registration Planning & Tracking, Submission Publishing & Lifecycle Management, Pharmacovigilance Management.
Before the scientific merit of a regulated healthcare product can be measured, the submission itself is subject to scrutiny and if during the validation process errors are found, this can delay or prevent the processing of a submission. EXTEDO is the trusted vendor to over 700 customers in 60 countries and has a 20 year proven track record of successful collaboration with life sciences organizations. As a trusted advisor in the eCTD field, we have developed an electronic submission validation product which guarantees that all relevant validation sets are included and up-to-date.
EURSvalidator is used by over 35 authorities worldwide, including EMA, to ensure eCTD and NeeS compliance. It enables you to easily validate medicinal and veterinary electronic submissions. EURSvalidator is available in several versions providing functionality and validation sets tailored to your region.