BlueReg supported a US-based client with a European Paediatric Investigation Plan (PIP) for their product. BlueReg initially provided guidance with the paediatric regulatory strategy and its potential impact on the PIP Application positioning. Subsequently, BlueReg wrote the PIP Scientific Document…
The Vice-President Global Regulatory Affairs of a US based company developing an important innovative product (orphan drug) contacted BlueReg to seek regulatory support to discuss the different stages of development in Europe. Our Client Objectives: Understand the pathway towards approval…
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!