Maria Nilsson Hagberg

As a regulatory specialist Maria’s key areas of expertise are regulatory project lead, dossier gap analysis, regulatory CMC, marketing authorisation applications and variation applications.

She has extensive knowledge in regulatory requirements and the different pre- and post-market procedures. Maria also supports clients with review and guidance for their promotional materials and activities. 

She has gained her experience from various regulatory roles at companies such as Fresenius Kabi, Pharm Assist Sweden, Oasmia Pharmaceutical, NDA Group and RegFile. 

Maria is driven by making the regulatory framework more understandable to our clients and finding solutions on how to meet the requirements.