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 affairs is at the crossroad of various disciplines, all needed to meet the goal of a successful registration procedure. Dorian Regulatory Affairs BV has established a network with colleague consultants in Europe and the US, specialist in their own areas, to assist if necessary. Amongst others, this includes toxicology, medical writing, pharmacovigilance, pricing & reimbursement and GMP. But also contacts with national regulatory consultants in the various EU countries and the US, for specific national advice if necessary.