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Regulatory expertise

Clinical Research at Desitin

  • Continuous maintenance of appr. 400 marketing authorizations (EU and ex EU)
  • Long-term experience with different authorization procedures e.g.  
    • 2010: Several DCPs with Germany as RMS and 9 CMS (levetiracetam); with 4 months procedure duration, one of the fastest DCPs in Europe 
    • 2015: Positive Orphan Drug Designation from EMA for Sirolimus (topical treatment of tuberous sclerosis)
    • 2016: DCP for a special combination product (combi-blister including Levodopa/Carbidopa + Pramipexol) 
  • 16 Regulatory Affairs Manager, approx. half of the team Senior Manager with more than 10 years of experience
  • Document Management System „docuBridge“ for eCTD-submissions and “drugTrack” as Regulatory Information Management System
  • Close contacts to the German BfArM, one of the top 5 Health Authorities in Europe
  • Subsidiaries with regulatory experience
  • Access to a network of regulatory consultants in Europe