Clinical trials
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Highbury Regulatory Science provides regulatory consulting services to small and mid-size biotech companies across drug development stages. They have supported clients through preclinical planning, IND submissions/amendments, end-of-phase meetings with FDA/EMA/national regulators, and strategic board advisory roles. Their expertise spans oncology, infectious diseases (including neglected diseases), rare diseases, devices and diagnostics. The company has enabled successful regulatory interactions for multiple client programs at various clinical stages but does not sponsor its own clinical trials or products.
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