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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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Commercial Services

Almac Pharma Services provide a wide range of customised commercial services from supporting product launch, manufacturing and / or packaging drug product, to securing supply chain with global serialisation solutions.

Our flexible, quality-led commercial solutions range from orphan drug launches to ongoing high-volume commercial product manufacture, packaging and supply.

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