EDQM Latest News!

New Application Forms & Submission Portal

June 9, 2017

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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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Brexit updates for human use medicinal products approved via MRP/DCP

December 21, 2020

As Brexit is quickly coming closer, the CMDh has published an updated version of the Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP in December 2020.

Javier Febrero Alija – New Regulatory Information Manager

December 17, 2020

Asphalion is excited and proud to officially welcome Javier Febrero Alija to its team as Regulatory Information Manager, expert in Data Management and RIMS.

Season’s Greetings

December 17, 2020

We wish you Happy ‘Xmas, Prosperous New Year and Health for you and your loved ones.

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New Application Forms & Submission Portal

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Brexit updates for human use medicinal products approved via MRP/DCP

Javier Febrero Alija – New Regulatory Information Manager

Season’s Greetings

EDQM Latest News!

New Application Forms & Submission Portal

Search

Filter by category

Related news and events

Brexit updates for human use medicinal products approved via MRP/DCP

Javier Febrero Alija – New Regulatory Information Manager

Season’s Greetings

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