Regulatory Affairs Management
Preparation and submission of new marketing authorization applications to Swissmedic
Life Cycle Management of existing products
Answering inquiries from the authorities (Response to Questions based on List of Questions)
Due diligence review (dossier)
Liaison with Swissmedic
In-house regulatory trainings
Review and adaption of SmPC (patient leaflet and professional product information) based on available scientific data
Consulting in submission strategies
Control of promotional material for compliance with Swiss Regulations