Italian regulatory affairs, handled locally
Registering and maintaining a medicinal product in Italy requires continuous interaction with the national authority, documentation in Italian and an understanding of local expectations. Nexus acts as your regulatory function in Italy, from the first assessment of the dossier to the maintenance of the authorisation over time.
What we take care of
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01
Regulatory assessment
Feasibility review of the product against Italian requirements, with the options and the risks stated up front.
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02
Dossier review
Gap analysis of the existing CTD documentation and a list of what needs to be completed or adapted.
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03
Italian product registration
Preparation and filing of the marketing authorisation application through the applicable regulatory route.
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04
Submission management
Compilation, validation and electronic submission, with tracking of every step of the procedure.
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05
AIFA / authority interactions
Direct communication with the authority, management of questions, deficiency letters and clarification requests.
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06
SmPC, PIL and labelling management
Preparation and alignment of the Italian SmPC, package leaflet and labelling with the approved texts.
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07
Regulatory follow-up
Monitoring of procedural deadlines, commitments and post-approval obligations.
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08
Variations
Classification, preparation and submission of type IA, IB and II variations.
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09
Renewals
Preparation and filing of renewal applications within the applicable deadlines.
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10
Lifecycle management
Continuous maintenance of the authorisation across its whole commercial life.
How a registration project runs
Assessment
We review the product, the dossier and the target timeline.
Plan
You receive the regulatory route, the gap list, the timeline and the scope.
Submission
We prepare, validate and file the application.
Procedure
We manage the authority interactions until approval.
Maintenance
Variations, renewals and regulatory follow-up over time.
Registration is not the finish line.
Once the authorisation is granted, the product still needs Italian artwork, packaging, local suppliers and a distribution route. If you would rather not manage those separately, Full Service Italy covers them under one contract.
Register a product in Italy
Send us the product details and we will come back with the applicable route and a realistic timeline.