Variations
Classification, preparation and submission of type IA, IB and II variations, including grouped and worksharing submissions.
After approval
The work that begins once the product is authorised
Manufacturing changes, text updates, safety information, renewal deadlines and artwork revisions accumulate over the life of a product. Left unmanaged, they become supply interruptions. Nexus tracks and files them as a continuous programme.
Services
What lifecycle management covers
Renewals
Monitoring of expiry dates and preparation of renewal applications within the required lead time.
Regulatory maintenance
Alignment of the Italian documentation with the core dossier and with regulatory updates.
Artwork modifications
Update of packaging, leaflets and labels following approved text changes, with print coordination.
Safety updates
Implementation of safety-driven text changes and coordination with pharmacovigilance obligations.
Portfolio tracking
A single status view of every product, procedure and deadline in your Italian portfolio.
One dashboard for the whole portfolio
For companies with several authorisations in Italy, we maintain a consolidated tracker of products, procedures, deadlines and artwork versions, reviewed with you on a regular cadence.
Keep your Italian portfolio current
Send us the list of your Italian authorisations and we will map the upcoming obligations.