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.