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Provides EU regulatory, pharmacovigilance, quality and compliance support for LUMEVOQ.
October 5, 2020
By: Contract Pharma
Contract Pharma Staff
Diamond Pharma Services, a technical services and regulatory affairs consulting group, provided EU regulatory, pharmacovigilance, quality and compliance support to GenSight Biologics, including the preparation, authoring support, agency communication and submission of GenSight’s first Marketing Authorization Application to the European Medicines Agency (EMA), for its novel ocular gene therapy LUMEVOQ. The EMA decision is expected in the second half of 2021. LUMEVOQ (Lenadogene nolparvovec) is ...
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