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- Support in development of regulatory affairs strategies for NCEs and generics
- Scientific advice management
- Building Modules 2.3S, 2.3P and M3 of eCTD for IND/IMPD/NDA/ANDA and EU registration dossiers
- RA support during product development of CMC dossier parts
- Due Diligence on CMC part of registration dossiers (NDA/ANDA/EU) in view of licensing-in or initial submissions
- Drafting of Paediatric Investigation Plans
- EU Submission management (CTAs/MRP/DCP/CP)
- Product life-cycle management, e.g. submission of variations, renewals and/or line extensions
