Resources
Discover a collection of resources tailored for biopharma companies looking to enter the European market.
Posts by Nicolas Schmitz:
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?
Exploitant Services in France for Pharmaceutical Companies
Discover why the Exploitant role is essential in France, and how does AzurBio support pharmaceutical companies in meeting this requirement.
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?
How to file your Marketing Authorization the right way
Avoid those 6 common mistakes and file a successful Marketing Authorization with the EMA.