- Europe is the 2nd biggest pharmaceutical market in the world, with over 200 M € in 2020.
- This market holds steady and extensive growth and is becoming increasingly attractive to investors, being more competitive and accessible.
- Azierta provides global support to access the European Pharma Market to Non-European companies.
Accessing the European Market
There are three main strategies that may be implemented on an individual basis, or alongside each other, depending on your company needs, in order to secure your correct positioning in the EU Market.
Becoming a MAH through a dossier adaptation
- European GMP Certificate.
- European GMP Certificate.quivalence and manufacturing documentation.
- Development of an EU Dossier (eCTD).
- Establishment of an EU location.
- Deployment of European resources and technical requirements.
- European MAH.
Becoming a MAH through Dossier Acquisition
- European Dossier Audit.
- European location resources and technical requirements.
- European MAH.
- Additional process: European GMP inspection and technology transfer to non EU manufacturer.
Becoming a suitable CMO for the EU
- Voluntary European Authority Inspection.
- European GMP Certification.
- Inclusion as manufacturer in an European dossier.
