Regulatory Affairs & Product Registration
Regulatory strategy, dossier review, Italian submissions, authority interactions and lifecycle management.
Regulatory Affairs
Who we are
A local partner for international pharmaceutical companies
Nexus Pharma Trade S.r.l. is an Italian pharmaceutical company operating across regulatory affairs, product registration, local operations and the authorised parallel import of medicinal products.
We work with manufacturers, generic companies, marketing authorisation holders and international groups that need a local counterpart in Italy — a partner able to interface with the authorities, the manufacturing sites, the printers and the distribution network on their behalf.
Our model is deliberately operational. We do not stop at regulatory advice: we take responsibility for the activities required to bring a product from dossier to pharmacy shelf.
Backed by professionals with extensive experience in the pharmaceutical industry.
Business lines
Three areas of activity
Full Service Italy / Market Entry
An outsourced regulatory and operational team covering registration, artwork, packaging, suppliers and launch.
Full Service ItalyParallel Import
Import and distribution of medicinal products authorised in other EU member states, under AIFA authorisation.
Parallel Import
How we operate
Principles we work by
Compliance first
Activities are carried out in line with Italian and European pharmaceutical legislation, including Legislative Decree 219/2006 and Directive 2001/83/EC.
Documented processes
Relabelling and repackaging are performed by AIFA-authorised sites operating under GMP and GDP.
Product integrity
Temperature-controlled transport and monitored storage conditions across the supply chain.
Accountability
One point of contact, one plan and one team answering for the whole programme.
Company information
Legal name
Nexus Pharma Trade S.r.l.
Registered office
Viale Monte Santo 4, 20124 Milan, Italy
Operating site
Via Bocconi 6/8, Tavazzano con Villavesco (LO), Italy
Company register
Milan, Monza Brianza, Lodi
VAT / Tax code
12506380968
Working languages
English, Italian, French
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