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Rbdcov Recap Portada

RBDCOV Project | Asphalion’s Key Regulatory Support in the Development of the COVID-19 Vaccine

Asphalion is proud to have been the regulatory partner in the Horizon Europe RBDCOV project, which aimed to develop and bring to market a recombinant protein-based COVID-19 vaccine for vulnerable populations, including children and immunocompromised individuals. Throughout the project, Asphalion provided end-to-end regulatory support: Strategic regulatory planning from early development through to the marketing authorisation application (MAA) Scientific Advice submissions to European regulatory agencies Dossier preparation for clinical trials and the full eCTD submission for regulatory review Guidance on innovative regulatory pathways and emergency use procedures In April 2022, the European Medicines Agency (EMA) initiated a rolling review of the

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