IND preparation and submission

Case Study | Bridging EU and US: IND preparation and submission

May 24, 2022

Dealing with FDA can be challenging!!

Have a look at a recent success story of how Asphalion prepared and submitted an IND to FDA for a small European biotech company.

At Asphalion we can assist you with your FDA projects, thanks to our extensive track record of over 20 years.


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Related news and events

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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