stage1 :BRINGING DRUGS TO MARKET
- Strategy for registering/submitting marketing authorisations, simplified marketing authorisations, etc.
- Drafting of the CTD:
- Administrative data & data relating to the correct use of the drug (Module 1): SPC, Labelling, Package leaflet, etc.
- Scientific data relating to the drug (Modules 2 to 5): quality summary, non-clinical, clinical, chemical, pharmaceutical, clinical studies, etc.
- Support operations in the fields of pharmacovigilance & risk management (Dir. 2010/84/EU)