Regulatory / Registration only
You keep operations in-house. We handle assessment, submission and approval in Italy.
Regulatory Affairs
Qualification
Are you…
- A pharmaceutical manufacturer?
- A generic pharmaceutical company?
- A Marketing Authorization Holder?
- A European or international pharmaceutical group?
- Looking for a local Italian partner?
- Managing a portfolio requiring registration in Italy?
Nexus can support your portfolio.
From a single registration to a complete market entry programme, we provide the local regulatory and operational structure your products need in Italy.
What happens next
A structured way in
01
You share the portfolio
Products, current authorisations, target timeline and the level of support you are looking for.
02
We assess
Regulatory route, dossier readiness, operational requirements and realistic milestones.
03
You receive a proposal
Scope, responsibilities, phases and timeline — for one product or for the whole portfolio.
Levels of support
Three ways to work with us
Regulatory Lifecycle Management
We maintain your Italian authorisations: variations, renewals, artwork and safety updates.
Lifecycle ManagementFull Service Italy
We manage the full local programme, from registration through to commercial launch.
Full Service Italy
Portfolio enquiry
Tell us about your portfolio
The more detail you provide, the more precise our first response will be. All enquiries are treated as confidential.
What you get back
- A first assessment of the applicable regulatory route
- An indication of the documentation required
- A realistic view of the timeline to authorisation
- A proposed scope of support for your portfolio
Prefer to write directly?
We make the Italian pharmaceutical market accessible.
One partner. One market. From dossier to launch.