Geographic Expansion and Verification of Regulatory Requirements

August 5, 2022

Pharma

Geographic Expansion and Verification of Regulatory Requirements

Regulatory Activities, Global Expansion, Geographic Expansion

INDUSTRY

Pharma

SERVICE

Regulatory Affairs & Pharmacovigilance

STRUMENTI E SISTEMI

Situation

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.

Task

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.

Action

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.

Results

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.