Announcement of experienced PharmaLex leadership for BlueReg ensures strength and stability for the business amid ongoing integration Frankfurt, Germany – 14 November 2022: PharmaLex Group, a leading provider of specialized services for the Pharma, Biotech and Medtech industries worldwide, has appointed experienced PharmaLex leader…
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…
As you want to start regulatory interactions in Europe for an orphan drug, you may face many challenges or miss game changing opportunities. Indeed, the European Medicines Agency (EMA) provides specific incentives to companies who are granted ODD for…
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.