Launching your product on to the European Market can present a real challenge if you are not familiar with country specific requirements. In this eBook our expert Orphan drug product launch team share their knowledge and experience regarding:

• The EU rare disease marketplace
• Regulatory / MA submission considerations
• Quality requirements – EU import testing and QP release
• Packaging design and regionalisation considerations
• Serialisation
• Almac’s Orphan Drug expertise
• Almac’s Seamless Brexit Solution