September 18, 2024
Pharma
Regulatory Activities, Global Expansion, Geographic Expansion
INDUSTRY
Pharma
SERVICE
Regulatory Affairs & Pharmacovigilance
STRUMENTI E SISTEMI
The client company, after registering its latest product in Europe, decided to expand the market in some areas of the Middle and Far East but the lack of staff did not allow it to manage the various activities at the same time.
To manage its needs, the customer turned to JSB asking for support for some activities in the geographic expansion field: - verification of registration requirements, - intermediation between the countries concerned - drafting of the registration dossier.
After identifying a dedicated team, with adequate previous knowledge in the countries where registration was required, a training course on the product in question was activated. At the same time, the team was trained on the client's internal procedures and on the operations to be followed in project management. After this first training phase, the team took steps to deepen the registration requirements, and consequently for the preparation of the dossier.
In a few weeks, the team managed to register the product and finalize the marketing several months in advance, ensuring an increase in turnover, as well as early access to the drug for the countries involved.