Development Project for Bio-Tech company

Evaluation of data requirement for filing and building of full dossier (module I –V). The assignment also included preparation and follow of scientific advice and ultimately project management of new application and pending procedure in EU.

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Gap analysis of outdated dossiers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