Resources
Discover a collection of resources tailored for biopharma companies looking to enter the European market.
Launching in EU - Q&A 5
How should we plan our launch sequencing across European countries, considering timelines for approval, pricing, and access?
Launching in EU - Q&A 4
What additional national regulatory requirements must we navigate after EMA approval?
First interactions with EMA - Q&A 7
What regulatory pathway missteps should we avoid, and how can we streamline our EU dossier preparation?
First interactions with EMA - Q&A 2
How does the EU drug development landscape differ from the US ?
Launching in EU - Q&A 3
How to choose the right location for our European headquarters or hub?
Launching in EU - Q&A 1
Why is launching a drug in Europe different from launching in the US?
First interactions with EMA - Q&A 1
What are the different regulatory pathways available when expanding to Europe and which one is the best fit for me?