EXTEDO is the only vendor in the market that is able to cover the complete regulatory landscape, including Product Registration Planning & Tracking, Submission Publishing & Lifecycle Management, Pharmacovigilance Management.
The viewing & reviewing of electronic submissions is a key factor in facilitating an efficient rapport between authorities and industry. Submissions need to meet the validation, acceptance, import, review and maintenance requirements of the EMA (European Medicines Agency), the associated national competent authorities (NCAs), and authorities outside of the European Union, e.g. the FDA (US) or the Swissmedic (Switzerland).
EXTEDO has cooperated with regulatory agencies to deliver the best possible solution designed to meet the submission needs of life science organizations.
EURS (EXTEDO Universal Review System) serves as a complete eCTD validation and reviewing solution used by over 35 authorities worldwide, including EMA. It evaluates whether any eCTD- or NeeS-based submission conforms to the mandated standards.
eSUBmanager provides a modern, end-to-end solution that improves the collaborative review process surrounding submission content and metadata for submissions in all stages as a stand-alone solution or companion for other tools.