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
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, EU gap analysis, EU/FDA agency meetings, EU Marketing Authorisation Applications, EU variation applications and promotional compliance in Scandinavia.
CMC & regulatory
Lina is a CMC regulatory specialist and ex-regulator. Her key areas of expertise are CMC gap analysis and strategy, CMC scientific advice, review and compilation of CMC documentation for clinical trials and marketing authorisations and variations. Lina has a background as a quality assessor at the Swedish Medical Products Agency (18 years), dealing with all types of EU regulatory procedures. Moreover, Lina has been active as a regulatory CMC consultant for a few years.
Åsa is a medical / regulatory writer with focus on module 2 overviews and summaries, investigator’s brochures and briefing documents. Åsa has a Ph D in experimental medicine from Karolinska Institutet, with focus on immunology. Her main scientific expertise areas are immunology, vaccines and biologicals. Åsa is experienced in pre-clinical development also in the writing of scientific summaries and popular science texts from working with research funding foundations.