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)