Regulatory expertise

» 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