Driving access to Innovative Therapies Through Strategic Partnerships Innovation is only meaningful when it reaches the people who need it. At PharmaBlue, we help biotech and pharmaceutical companies bring 30+ innovative therapies and orphan drugs to French patients—faster and more…
Rare diseases: At the core of our mission At PharmaBlue, we’ve spent the past decade supporting biotech innovators in bringing their rare disease therapies to patients in France—quickly, compliantly, and with care. As a licensed Exploitant, we specialize in managing…
Expanded Access is a treatment option that allows the use of an unauthorized medicine (investigational drugs). Under strict conditions, products in development (with ongoing clinical trial) can be made available to groups of eligible patients who have a disease with…
Main benefits of outsourcing "Exploitant" status : Reminder : French regulatory authorities require having an « Exploitant » authorized and established in France to manage an early access program in France or a Marketing authorization. Immediate activation of French Affiliate…
Known as Expanded Access Programs in the US, early access programs (EAP) allow access to medicines for certain patients before marketing authorization. The French early access program, authorization for temporary usage or temporary authorization (“autorisation temporaire d’utilisation” - ATU), was…