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EU Orphan Drug Launch – Understanding and delivering your EU Orphan Drug Launch

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

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