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.

 

Health Technology Assessment (HTA)

In an era characterized by the aging of the population and consequently of chronic diseases, by the expectations of the population that requires global coverage of health costs, migratory flows, the continuous increase in the cost of drugs and technologies applied to health every new drug or medical technology allowed to benefit from coverage by the National Health Systems requires a multidisciplinary evaluation of the medical, social and ethical costs that it entails.

The Health Technology Assessment supports the public decision-maker to give priorities and the right value to every healthcare choice and consequently is one of the cornerstones of the approval, pricing and reimbursement process that the pharmaceutical industry must adequately document to get to the commercialization of a drug.

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.