EDQM Latest News

From January 23rd 2017 two new application forms are mandatory.

ASPHALION

New Application Forms & Submission Portal

From January 23rd 2017 two new application forms are mandatory:

  • New CEP application
  • Request for revision or renewal

From January 23rd 2017 CESP is the portal that must be used to submit documentation to the EDQM.
Asphalion has wide experience with:

  • All procedures types: CP, DCP/MRP, NP, FDA, Health Canada
  • eCTD publishing and trainings
  • eSubmissions (CESP, FDA, EMA, National Authorities)
  • Worksharing

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