Pro-Pharma Ltd.
 
 
Pro-Pharma Ltd.
Pro-Pharma Ltd.
Pro-Pharma Ltd.
Pro-Pharma Ltd.
Pro-Pharma Ltd.
Pro-Pharma Ltd.
Pro-Pharma Ltd.
Pro-Pharma Ltd.
Pro-Pharma Ltd.


 

Regulatory and Expert Services:

  • Compilation of registration dossier
  • Evaluation of documentation and production of deficiency lists
  • Medical writing:
    • Expert overviews and summaries
    • SmPC, PIL and Label
    • Translations
  • eCTD compilation and publishing
  • Application to authorities (national, MRP and decentralized procedures)
  • Coordination and follow-up during the registration process
  • Continuous contact with the respective authorities, organisation of meetings
  • Life-cycle management including
    • Variations
    • Renewals
    • Other modifications
  

 

Pro-Pharma Ltd.

 

 
H-1122 Budapest, Magyar jakobinusok tere 4/B. III.3., HUNGARY
tel.: +361-231-80-60, +361-369-02-80
fax: +361-370-89-10
e-mail: company@propharma.hu