Team
Maria Santesson
MSC Pharm
CEO, REGULATORY AFFAIRS
Maria is a regulatory affairs specialist, supporting with general regulatory affairs management, eCTD dossier writing, procedure management and regulatory operations.
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, CMC
Maria’s 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.
Maria is a regulatory affairs specialist with 20 years of experience managing regulatory activities in the pharmaceutical industry.
Elisabeth Widmark
MSC pharm
regulatory affairs, CMC PHARMACOVIGILANCE, gdp
Elisabeth’s key areas of expertise are regulatory procedures, regulatory CMC as well as local Nordic regulatory affairs. She also has extensive experience from Good Distribution Practice (RP) and pharmacovigilance.
Elisabeth is a regulatory affairs specialist with 20 years of experience managing regulatory, pharmacovigilance and GDP activities for pharmaceutical companies.
Brilliant partners
We collaborate closely with our colleagues within CTR, which gives us access to the perfect set of experts for your project. When applicable and if you agree, we will bring the suitable specialist / back-up to our projects, as subcontractors. Below you find links to the profiles of some our closest collaborators.
Drug development regulatory specialists
Marie Gårdmark, Clinical
Ira Palminger Hallén, Clinical
Robert Hägerkvist, Clinical
Agneta Larhed, CMC
Sophie Bertilsson, CMC
Eva Ragnarsson, CMC
Torbjörn Wärnheim, CMC
Lizette Granberg, Toxicology
Eva-Lena Glämsta, Toxicology
Pharmacovigilance specialists & auditors
Quality assurance specialists & auditors
