Currently, validation issues occur in 90% of initial marketing authorisation applications (MAAs). These validation issues create additional workload for companies and potential delays at a critical moment for the timely start of the procedure.
To make the validation process more efficient, predictable and easier to navigate, EMA has release a new validation checklist.
EMA is encouraging applicants to submit this new validation checklist as part of the MAA dossier.
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Asphalion has extensive experience with Centralised Procedures.