You decide to sub-contract production. Ipsen also offers the full range of relevant services.
As far as regulatory service are concerned,, Ipsen offers to prepare your CMC pharmaceutical documentation (Chemistry Manufacturing Control):
- Preparation of dossiers and license variations
- Analysis of new products, updating dossiers and strategy proposals
- Audit and approval of raw material suppliers
- Medicinal product stability studies
- Preparatory service for registration dossiers for active substance manufacturers