Unlike other regions, in the EU a number of options is available to obtain a marketing authorisation. Centralised at the European Medicines Agency in Amsterdam or decentralised with the individual competent authorities of the member states, each marketing authorisation application procedure has its pros and cons.
We know the right consultants whom have extensive experience in European regulatory affairs. We can therefore provide you with independent and optimal advice on the best suitable regulatory strategy on a case-by-case basis. We know the right local regulatory consultants.
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