Scientific Service

 

Market Access
Other Services
Scientific Service
Medical Devices\Foods
Proxy Service

Each MAH must be equipped with a scientific service in charge of information about the medicinal products that enter in the market (Art 126 Legislative Decree 219/2006). GB Pharma supports the clients about:

  • Advice on compliance with article 126;
  • Assumption of Responsibility of the Scientific Service;
  • Assessment of regulatory compliance of promotional materials;
  • Regards to medical representatives: confirmation (preparation of badges, Preparation and submission of the annual communication to AIFA on the activities of medical representatives, preparation and submission of notifications regional (annual and half-yearly) on the work of medical representatives).

Regulatory support in Extra-EU Countries

  • Support for the registration and maintenance of medicinal products in Extra-EU Countries (e.g. Middle East, North-Central and South America, Asia, Africa, etc.), in accordance to local procedures and requirements.
  • Development of the registration dossier and support during all registration process phases, also with co-operation with local agents.