September 8, 2022

Have a look at this infographic that Extedo® and Asphalion have prepared with the summary updates in terms of publishing and eSubmission at a regional level, focused on INDs for US FDA!

The US law requires that a drug be the subject of an approved marketing application before it is transported across state lines, e.g., to clinical investigators. The IND is the way for the sponsor to get this exemption from the FDA. So, before a new drug in a preclinical development status can be used for clinical studies, an IND has to be submitted.

ASPHALION and our partner Extedo® can offer you a wide range in Regulatory Services and Solutions in the United States. Asphalion can support you throughout the whole lifecycle of the IND procedure in a variety of activities.

Check the document here:

Flyer IND Publishing Asphalion Extedo

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¡Ya ha comenzado el 41º Symposium de AEFI! No olvidéis visitarnos en la mesa 3 para conocer de todos los servicios que ofrecemos. Os recordamos

NEW! | The 3rd eAF-PMS Newsletter has been published on the EMA website!

This 3rd edition of the eAF-PMS
Newsletter highlights the latest news,
upcoming events and activities planned
for the next months. An updated
timeline of the web-based Human
Variations electronic application
form (eAF) accessible from the
Product Lifecycle Management
(PLM) Portal is now available to all
interested stakeholders. The timeline
highlights important milestones to be
achieved in the upcoming months with
regards to the release of new
functionalities, User Acceptance Testing
(UAT) and start of the transition period.
A version of the timeline highlighting
impacts on the eAF users in the
different periods is also available for
If you are interested in the progress of

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