SERVICES

Regulatory Services

   Clinical Trial Applications (EU)
   Non-Interventional Studies (EU)
   Orphan Drug Designation (US/EU)
  
EMA Scientific Advice
   
European National Advice Meetings
  
Compassionate use programs
   Paediatric Investigation Plan

European Licensing

   Centralised Procedure
   Decentralised & Mutual RecognitionProcedure
   National Procedure
   License Applications (CTD)
   License Variations/Amendments
   License Renewals

Expert Advice

EU Regulatory Strategy & Requirements

Arbitration process

Other Services

   Regulatory Affairs Staff Training
   On-site Interim Management
   Labelling and Promotional Materials
   Medical writing
   Project Management
   Regulatory Affairs Intelligence
   Literature search
   Database search (DIMDI, etc.)
   Standard Operating  Procedures (SOPs)