A US‑based client entrusted the European legal representation and the application/granting of their SME status to BlueReg. BlueReg coordinated the client’s SME dossier preparation and submission to EMA, optimising the application content to expedite its approval.
In this White Paper you will learn how to design a regulatory strategy to optimize registration of ATMPs with the EMA: Regulatory tools for early interactions with the EMA Early Access to the EU market How can BlueReg help?…
Understand and take advantage of European Medicines Agency (EMA) incentives for orphan medicinal product. Download our EMA Incentive sheet!
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…
In this white paper you will learn: Basic EU legislation for medicinal products Legal basis of the application in the EU Hybrid applications How to present your Hybrid application Timetable for Hybrid applications under Article 10(3) of Directive 2001/83/EC…