• Provision of MS Word templates for EU Module 1 to 5
  • Creation of eCTD-compatible documents considering the applicable directives
  • Compilation of eCTDs (including baseline eCTDs) and non-eCTDs (NeeS) for
    initial submissions, variations, renewals and other submissions using proprietary software (EXTEDO eCTD Manager) or client software (Lorenz docuBridge)
  • Integration and testing of functioning links (references, figures and tables)
    in documents and within the eCTDs
  • Submission of documents via CESP (Common European Submission Platform)
  • Entry and maintenance of data in the XEVMPD database of the EMA