Team
Maria Santesson
CEO, MSC Pharm REGULATORY AFFAIRS
Maria is a regulatory affairs specialist, supporting with general regulatory affairs, eCTD dossier writing and procedure management. She’s an experienced regulator and has served 10 years as pharmacokinetics assessor at Swedish MPA and 10+ years as a general regulatory affairs consultant working with a wide variety of product, applications and procedures.
Maria N Hagberg
MSC Pharm
REGULATORY AFFAIRS
Maria is a regulatory affairs specialist with 20 years of experience managing regulatory activities in the pharmaceutical industry. Her key areas of expertise are regulatory project lead, dossier gap analysis, regulatory CMC, EU/FDA agency meetings, EU Marketing Authorisation Applications, EU variation applications and promotional compliance in Scandinavia.
Elisabeth Widmark
MSC pharm
regulatory affairs
Elisabeth is a regulatory affairs specialist with 20 years of experience managing regulatory activities for pharmaceutical companies. Her key areas of expertise are regulatory procedures globally, regulatory CMC as well as local Nordic regulatory affairs. She also has extensive experience from Good Distribution Practice (RP) and pharmacovigilance.
