GAP provides access to medicines for patients in countries where there is no commercially available treatment option for the condition. For many pharmaceutical companies this can be challenging due to different regulations in each country. GB Pharma is very knowledgeable in regulatory affairs in the countries we provide product or service and already work with many physicians and hospitals in these countries. We can help US companies accomplish their GAP goals and provide all documentation accountability requirements necessary to be compliant with US laws.
Managed Access Program (MAP):
MAP allows pharmaceutical companies to provide pre approved drugs to patients around the world through “Compassionate use”, “Expanded use” or’ Named patient supply”. Our team of consultant, US licensed physicians and pharmacist already provide patient co-management services and can therefore manage various MAP programs.
If you are a pharmaceutical company, hospital, physician or patient interested in GAP and MAP contact us for more information on how we can help.