What’s New in eSubmission?

The eCTD EU Module 1 v3.0 has been released for public consultation.

July 24, 2015

The updated specification (highlighted and clean)
versions with relevant release notes and comments template are now available on
the EU M1 page of the eSubmission website.

Comments should be provided by 14 September 2015 to [email protected]

If you have any doubts regarding the matter, please do not hesitate to contact us at [email protected]

Search News & Events

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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What’s New in eSubmission?

The eCTD EU Module 1 v3.0 has been released for public consultation.

Search

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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

About

Team

Partners

CSR

AI Ethic Code

Careers

What’s New in eSubmission?

The eCTD EU Module 1 v3.0 has been released for public consultation.

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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