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

..
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

SME

The EMEA offers small and medium enterprises the possibility to obtain SME status. SME status is associated with various advantages, ranging from financial incentives to procedural assistance. Requirement is that the company is established in the EEA.

Dorian Regulatory Affairs BV can help you arrange SME status. For companies located outside the EEA, Dorian Regulatory Affairs BV offers the opportunity to obtain SME status through Dorian's SME status.