Phase 1
Assessment
We establish whether, how and when your product can reach the Italian market.
- Product assessment
- Dossier readiness
- Regulatory route
- Gap analysis
- Launch planning
The model
An outsourced pharmaceutical operations team in Italy
Full Service Italy is our most complete offering. Instead of coordinating a regulatory consultant, an artwork studio, a printer, a repackaging site and a distributor yourself, you work with one partner that holds the whole plan — and one point of contact accountable for it.
- One contract, one plan, one point of contact
- Regulatory, artwork, packaging and local suppliers under one roof
- Designed for portfolios as well as single products
- Support continues after approval, through to launch
Structure
Five phases, from assessment to launch
Phase 2
Registration
We prepare and run the authorisation procedure with the Italian authority.
- Dossier preparation
- Submission management
- Authority communication
- Management of questions / deficiency letters
- Approval tracking
Phase 3
Market Readiness
We make the product physically and documentally ready for the Italian market.
- Italian packaging
- Artwork management
- Leaflets and labels
- Coordination with printers
- Coordination with manufacturers / officine
- Local supplier coordination
- Quality documentation
Phase 4
Lifecycle Management
We keep the authorisation and the artwork current over the life of the product.
- Variations
- Renewals
- Regulatory maintenance
- Artwork modifications
- Safety updates
- Portfolio tracking
Phase 5
Commercial Launch
We coordinate the operational steps that put the product on the market.
- Product readiness
- Distribution coordination
- Launch documentation
- Coordination with local partners
We don’t stop at approval.
Most regulatory providers hand the file over once the authorisation is granted. That is precisely the point at which the Italian operational work begins — packaging, artwork, printers, manufacturing sites, quality documentation and distribution. Full Service Italy covers all of it.
Scalable model
From a Single Product to a Complete Portfolio
Whether you are registering one product or managing an annual portfolio of launches and variations, Nexus provides a scalable local regulatory and operational model.
Enter the Italian market with one partner
Tell us about your portfolio and we will propose a phased plan with scope, responsibilities and timeline.