515 Consulting Group is an authorized partner with:

  • EXTEDO. 515 Consulting partners with EXTEDO as a reseller of their leading regulatory software applications including
    • eCTDmanager, a leading CTD/eCTD/NeeS/eCopy compilation, viewer, validator and publishing tool,
    • EURS, the official eCTD review and validation tool for the European Medicines Agency (EMA) and its associated countries,
    • PcVmanager, a leading drug safety management application,
    • DRAmanager, a leading Regulatory activities management and tracking application and
    • GLOBALvalidator, a stand-alone regulatory validation application that supports the validation of pharmaceutical, medicinal and veterinary eSubmissions for a large assortment of countries including the FDA, EMA (and its individual countries), Canada and more.
  • Sage Submissions. 515 Consulting partners with Sage Submissions, the author of the Sage Templates, the leading set of Global Regulatory Word Templates including:
    • US FDA CDER and CBER
    • ASEAN
    • Health Canada
    • European Medicines Agency (EMA)
  • Court Square Group. 515 Consulting partners with Court Square Group (CSG) for its hosted managed solutions. In the life sciences industry, CSG is recognized as a leading provider of expertise in quality, auditing and clinical technology services.

eCTDmanager, EURS, PcVmanager and DRAmanager are trademarks of EXTEDO.