The prerequisite for a life sciences company to request the Marketing Authorisation Holder (MAH) with the European Medicines Agency (EMA) is to have a permanent establishment within a country of the European Union.
 

The EMA requires proof of establishment and failing to comply can delay the application.

Of course, it is possible to appoint a representative, however the MAH remains responsible for assuring all the obligations imposed on MAHs by the European legislation and by national laws, as applicable.
 

It is therefore very important to think carefully where to establish first, as it will be determinant for the future of the European operations, including the companies and tax structure.

 

Life Science Services can support you with the following:

 

Due Diligence
 

Based on your business type, strategy and objectives, these are some of the elements we will consider before starting the incorporation of any subsidiary:

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• Substance and value chain creation analysis

• EMA submissions transferts

• Elaboration of a suitable tailor-made tax business model including intellectual property aspects (if any)

• Tax opportunities and tax risk analysis. 

 

Incorporation
 

You can set up a company in no more than 3 working days, and for a capital cost starting at EUR 100.
 

The requirements vary depending on the country. However, the EU encourages all countries to meet common targets for helping to set up new companies.
 

People Resources
 

We provide support to your international employees and team members under various forms:

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• Payroll company

• Interim management solutions

  • FTE for a limited period of time

• Management consulting solutions 

  • Project managers & advisors to manage and mentor your projects