Dorian Regulatory Affairs

Dorian Regulatory Affairs BV -- Soestdijkerstraatweg 7 -- NL-1213 VP Hilversum -- The Netherlands
tel. +31 35 622 19 34 -- fax +31 35 623 06 59 -- email info@dorian.nl

Services

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Strategic regulatory advice

Marketing authorization applications

Variation applications and line extensions

Liaison with regulatory authorities

Conversion into CTD

Updating of dossiers

Orphan Drug designation

Evaluation for in-licensing

Regulatory intelligence

SmPC´s and patient leaflets

Liaison with regulatory authorities

Over the years, Dorian Regulatory Affairs BV has established good contacts with the various EU authorities, as well as the EMEA. We will liaise with the various authorities on your behalf, and act as the official EU contact point for your procedure if necessary.