Gap analysis of outdated dossiers

Identification of gaps in outdated dossiers versus current legal requirements and regulatory guidelines. The assignment also included conversion of files from previous NtA format to current CTD-format.

Local representative
Acting QP
Start-up of a Swedish pharmaceutical company
Quality Assurance system
Development Project for Bio-Tech company
Gap analysis of outdated dossiers
Insourcing of pharmacovigilance function including QPPV
Third country batch release