CTD Dossier definition
CTD Dossier means SONOMA’s CTDs (Modules 2-3) of the Products updated as agreed during the due diligence, the Brazilian specific documents as identified during the due diligence, the GMP (Good Manufacturing Practices) documents as identified during the due diligence and all administrative documents (e.g. certificates, authorizations, approvals) required for Regulatory Approvals in the Territory.
CTD Dossier means the entire collection of descriptive methods of chemistry, manufacturing and controls (CMC) employed by VGN in the development, processing, manufacture, clinical trials and testing of Product that is the subject of this Agreement. The CTD Dossier forms the basis of the Registration referred to in 1.28.