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

Conversion into CTD

New marketing authorisation applications must be made in CTD format. For older products, it maybe necessary, or convenient, to convert an old MAA or NDA into a CTD. Dorian Regulatory Affairs BV can handle this activity for you, and advise if any information is missing to make the CTD up-to-date.