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Recent Projects

Clinical Development of A Drug-Device Combination

A US-based client wished to conduct a first-in-human clinical trial of a novel drug-device combination product in the UK. Both the medicinal substance and the medical device were well-known and approved separately in the EU but for different indications and intended purposes. CellData Services was p...

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Allogeneic MSC for tissue engineering

CellData Services is developing a long-standing collaboration with a UK-based regenerative medicine company, providing regulatory affairs support and expert guidance on a long-term basis. The company is adapting their core tissue engineering technology from autologous to allogeneic cells. This is a...

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EMA Scientific Advice for US-based somatic cell therapy

CellData Services was asked to provide a detailed assessment of the data available on a US-based somatic cell therapy for neurological disorders. As this product was at a quite advanced stage in its development for the US market, it was important for the client to gain an understandin...

Read case study | All ATMPs case studies