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