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

Scientific advice

SME

Paediatric

Related services

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Scientific advice

Despite the growing number of guidelines and notes for guidance, it is often a challenge to determine the best R&D package to achieve an expeditious and commercially attractive registration. Generally, companies are advised to avail themselves of the advice services offered by the EMEA and national authorities. Dorian Regulatory Affairs BV will arrange and participate in these meetings on your behalf.