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

Orphan Drug designation

Dorian Regulatory Affairs BV has handled many Orphan drug designation applications and can advise whether your drug potentially qualifies for EU Orphan drug status.

We can prepare the orphan drug application, arrange pre-submission meetings and follow-up until closure of the procedure on your behalf. As the applicant needs to be established in the EEA, Dorian Regulatory Affairs BV can act as applicant for non-EU companies without an EEA affiliate, until a company presence in the EEA is established.