PharmaBlue is a partner "Exploitant" of innovative Pharma Companies for the marketing in France of their medicinal products which have been granted an Early access authorization (EAP) or a Marketing Authorization (MA)
When a pharmaceutical company is primarily focusing on development but would like to outsource early access programme in France and Exploitant responsibilities in the field of rare or serious disease & unmet medical need, why is Pharma Blue a good choice?
From its creation, PharmaBlue has been involved in the efficient management of EAPs (Early access programs previously called ATUs) and early phase of post marketing authorization activities in France. Developing strong expertise in supporting Pharma companies to obtain early access authorization and manage them, we have gained a good reputation in the field of rare or serious disease & unmet medical need.
As an established pharma organization outside France or Europe, a company contemplates launching an orphan drug in France but have no affiliate to proceed further. How and why Pharma Blue could be the right solution for the company?
– PharmaBlue has built a robust quality management system to provide continuous and specific support to foreign companies willing to introduce new products to the French market.
– PharmaBlue with the support of its mother company PharmaLex offers the possibility to hold the Exploitant status and overlook pharmaceutical operations on the French Market.
– PharmaBlue has an experienced team in quality management and pharmacovigilance that is used to cooperate with firms in Europe and in the US.
You have a plan to create an affiliate in France, how could PharmaBlue be of help in this project?
– PharmaBlue can provide support to your plan of creation of a licensed pharmaceutical affiliate in France (with an Exploitant status) with a framework of progressive disengagement as your new business gets more resources and staffing.
– In addition, PharmaLex experts’ team will be able to support your affiliate obtaining the licensed Exploitant status and extend support and training to newly formed organization to ensure a smooth transfer of competency.