Can Freyr SUBMIT PRO generate and submit SPL labeling, REMS components, and drug listing information?

Yes, Freyr SUBMIT PRO can incorporate and submit SPL, SPM, REMS information, and drug listing information in Module 1 of the dossier. Freyr also provides an in-house application for generating SPLs and SPMs (Freyr SPL-SPM) at no additional cost.