Download the 5 Must-Knows about Paediatric Investigation Plan in the EU Why do we need an EU PIP? Is a PIP required ? Planning for the PIP procedure Overview of the PIP procedure 9 months to 1 year Content…
Download the Guideline on Orphan Drugs for US Pharmaceutical Companies willing to enter the EU Market: Legal basis Guidance Advantages Eligibility Regulatory Procedure
Download the 4 tips for biotechs developing orphan drugs for the EU market: Key facts about Orphan Medicinal Product (OMP) Regulation and Rare Diseases in the EU Cost and Incentives of OMPs Incentives & Orphands: A profitable market After…
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…