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

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Regulatory intelligence services

Keeping up to date with the EU legislation and guidelines in the area of the registration of human medicinal products is a core activity of Dorian Regulatory Affairs BV. We provide various types of regulatory intelligence services, varying from addressing a specific enquiry, to keeping you informed regarding a specific topic or area of development, to providing manuals such as a Mutual recognition procedure manual.