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HOME SERVICES DRUG DEV. CLINICAL TRIALS REGULATORY CASE HISTORY CONTACT

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 Intro 8

                    

ISO 2008

Regulatory  Regulatory Activities

 

  • Development of EU regulatory strategies (National, Mutual Recognition, Decentralised and Centralised procedures)

  • Dossier preparation: Quality, Safety, Efficacy

  • Clinical Trial Application

  • Marketing Authorization Application

  • Orphan Drug Designation and Scientific Advice (EMA)

  • Networking with Regulatory Authorities/Institutions on behalf of Clients

  • Legal Representation for companies not based in the European Union that need to deal with EMA or any National Regulatory Authority