Market Access

Market Access
Other Services
Scientific Service
Medical Devices
Special Foods & Supplements
Proxy Service

Advisory support for foreign companies in start up. GB Pharma offers integrated services of Regulatory, Market Access and Reimbursement; Pharmacovigilance and Medical-Scientific Services.

This service consists of but it is not limited to:

  • Possible set up strategies (legal representation, local representation, attorney, dealership agreement, distribution agreement.etc.)
  • GB Pharma could take the representation for the foreign company (assistance in steps required for the recognition of the company from HA; SIS code; AUA and users for the utilities AIFA Front End);
  • support for regulatory planning and logistics including the supply of pharmaceutical bollini though on line procedure).

Analysis and the definition of pricing strategies according to current regulations: Preparation of request for pricing (Price and Reimbursement Dossier), and assistance in negotiating with Health Authorities.

Submission of new products for inclusion in the list of reimbursable products, trough a critical review of data process and cost/benefit ratio of the product.

Insertion and maintenance of the products in PTOR;

Support for HTA analysis, budget-impact studies and pharmacoeconomic studies.

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.