EDQM Latest News!

EDQM Latest News!

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

Click here, we will be please to help you!

Igenomix receives EMA Orphan Drug Designation for its product indicated for Asherman's Syndrome with Asphalion support
Revive the FDA Open Seminar 2017 with this summary!

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