Variations are any change to the currently approved content of a Marketing Authorisation (MA) dossier and are essential in the lifecycle management of a medicinal product. For human use, this mainly concerns articles 8(3), 9, 10, 10a, 10b, 10c of…
A global company recently entrusted to BlueReg the management of pricing and reimbursement activities to bring their product on the French market. Pricing and reimbursement strategy and activities are specific to each country. In France, the positioning of the…
A pharmaceutical company contacted BlueReg experts on promotional material for review of a non-promotional website and associated chatbot. The chatbot is an interactive tool with which the user can interact. Different information, in relation with the website on which the…
A French pharmaceutical affiliate entrusted BlueReg to support them for the whole process of submission (advice, writing activities and support for meeting with the Competent Authorities) of a cohort Temporary Authorisation for Use (cATU) request to the ANSM for a…
