From Regulatory Approval to Market Launch
An Italian pharmaceutical services platform for international companies.
A single, structured route into the Italian market — with one team accountable at every stage.
Product assessment, regulatory route and gap analysis.
Dossier preparation and submission of the Italian application.
Authority communication, questions and deficiency letters.
Italian SmPC, PIL, labelling and print coordination.
Manufacturing sites, printers and local supplier coordination.
Product readiness, distribution and launch documentation.
Whether you only need Italian regulatory expertise, or a local team to manage everything on the ground, the entry point is the same.
You manage the business. We manage the Italian registration.
Your outsourced pharmaceutical operations team in Italy.
Whether you are registering one product or managing an annual portfolio of launches and variations, Nexus provides a scalable local regulatory and operational model.
A single registration handled end to end, with a defined scope and timeline.
Multiple products tracked in parallel, with consolidated reporting.
Recurring launches, variations and renewals managed as a continuous programme.
Nexus Pharma Trade operates across the full pharmaceutical value chain in Italy.
Regulatory strategy, dossier management, submissions and authority interactions for the Italian market.
Regulatory ServicesA complete outsourced regulatory and operational team: registration, artwork, packaging, local suppliers and launch.
Full Service ItalyAuthorised import of medicinal products already approved in other EU member states, for human and veterinary use.
Parallel ImportA local partner able to interface with the Italian pharmaceutical ecosystem — authorities, manufacturing sites, printers and distributors.
From initial assessment through registration and lifecycle management, with a clear view of the Italian requirements.
Nexus coordinates regulatory activities, artwork, packaging and local suppliers, so you manage one relationship instead of ten.
A company focused specifically on pharmaceutical operations, not a generalist consultancy.
Nexus supports the product beyond the regulatory approval stage, through to packaging, distribution and market launch.
Tell us about your products and we will come back with a structured view of the route, the requirements and the timeline.
