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

SmPC's and patient leaflets

All marketing authorization applications in the EU need to be accompanied by proposals for a SmPC and a patient leaflet, in accordance with the available guidance notes. Dorian Regulatory Affairs BV can prepare these texts in English and Dutch, and arrange the necessary translations in the other EU languages.