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European market access support services

  • 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.

Leading innovation in pharma & health

100 professionals

Over 100 professionals

500 clients

Over 500 clients

9 year experience

9 years of experience

Innovation

Leading innovation

Client oriented

100% client oriented

DO YOU HAVE ANY DOUBTS?

We help you in everything you need. Contact us by filling out the form or book an appointment for a video call with one of our experts.

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