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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Variation applications and line extensions

Sooner or later, all registrations require variations and/or line extensions to keep up with the scientific and regulatory developments and to maintain an efficient manufacturing process. These applications can be prepared and submitted on your behalf, both nationally and EU-wide, including follow-up until approval.