Project Orbis

Download our white paper dedicated to Project Orbis, a global collaborative review program to facilitate faster patient access to innovative cancer therapies across multiple countries.

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 10 key requirements to launch your medicinal product in the EU:   Local Representatives National Codes Blue Box Serialization Local Databases Local launch Date Notification Promotional Materials Educational Materials Local Wholesale Distribution Authorization (WDA) Shared Pack and Stock…

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…