Maria Santesson

As a regulatory specialist Maria’s key areas of expertise are regulatory project lead, full dossier compilations, marketing authorisation applications and variation applications. She has extensive knowledge in regulatory requirements and the different pre- and post-market procedures and activities. Maria also supports clients with eCTD dossier publishing and with product information translations and reviews. 

Maria served 10 years as a pharmacokinetics assessor at the Swedish regulatory agency MPA. She also gained experience from more than 13 years as a regulatory specialist consultant at Pharm Assist Sweden and RegFile, where projects have covered regulatory activities for a wide variety of medicinal products, applications and procedures, including drug/device combination products.