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Management & Implementation of ICH E2B ex- and imports

E2B – Lindeq supports in all aspects of implementing and managing ICH E2B ex- and imports

E2B submissions of ICSRs and SUSARs have been officially required within EU/EEA since November 2005. For your company E2B submissions are advantageous in some aspects, but does require quite a bit from you. You must ensure that your systems are E2B compatible and decide on how you will perform the actual submissions. Own E2B gateway? Or more manual processes involving e.g. the manual entry in the Eudravigilance web based entry application? We have solid E2B experience and can advise you and help you chose your most cost-efficient way of being E2B capable and fully compliant. Naturally, we can also assist you in actual E2B implementation and the required E2B testing with the national regulatory agencies as well as the later, day-to-day practical use and management of E2B in your system environment.

Please contact us for further information.

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