Electronic Regulatory Submission (eCTD) Tools and Processes

Everest uses proven technology and processes to build, view, validate, publish, and submit high quality ICH and regulatory agency compliant submissions in eCTD format.

  1. eCTD Submission Software – Everest has been using Extedo’s eCTDmanager since 2006, and has completed hundreds of eCTD submissions using this 21 CFR Part 11 compliant software with zero agency technical validation errors to date.
  2. Dedicated Server – Everest provides a secure sFTP server for transfer of submission documents between Clients and Everest.
  3. SOP-controlled Process – Our Regulatory Submission SOPs support our submission activities through a controlled process:
    • Legacy and new submission content review and sign-off
    • Document publishing
    • Document upload to eCTDmanage
    • Submission export
    • Everest QC review, Client review, Everest QA review
    • Submission release approval
    • Submission to agency, e.g. to FDA via ESG with submission acknowledgement
    • Submission archival
  4. Client audited; FDA remote audited of Everest processes and documentation with no findings/faults.

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