Team

Maria Santesson, M Sc Pharm
CEO, Regulatory affairs specialist

Maria Santesson, M Sc Pharm
CEO, Regulatory affairs specialist
Maria is a regulatory affairs specialist, assisting with general regulatory affairs support, 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 Nilsson Hagberg, M Sc Pharm
Regulatory affairs specialist

Maria Nilsson Hagberg, M Sc Pharm
Regulatory affairs specialist

Regulatory affairs specialist with 20 years of experience managing regulatory activities in the pharmaceutical industry. Maria has supported a number of medium sized and small pharma companies with everything from clinical trial applications to EU marketing authorisations and post-approval activities. Her key areas of expertise are regulatory project lead, EU gap analysis, EU/FDA Agency meetings, EU Marketing Authorisation Applications (MRP, DCP and CP), EU variation applications (DCP and CP) and promotional compliance in Scandinavia. Before she joined RegFile she has worked for a number of pharma companies and consulting organisations such as Fresenius Kabi, Oasmia Pharmaceutical, Pharm Assist Sweden and NDA group.

Lina Påve, M Sc Pharm
Regulatory CMC specialist

Lina Påve, M Sc Pharm
Regulatory CMC specialist

CMC regulatory specialist and ex-regulator with 18+ years of experience from regulatory CMC. 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 chemistry and pharmaceutical (quality) assessor at the Swedish Medical Products Agency, dealing with  new applications, renewals and variations. As agency assessor, she was involved in all types of EU regulatory procedures (NP, DCP, CP). Moreover, Lina has previous experience as a CMC consultant at Pharm Assist Sweden.   

Åsa Jansson, Ph D
Medical / regulatory writer

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 and has managed in vitro and pre-clinical efficacy studies and documentation for the development of a biological. In addition, she is experienced in writing scientific summaries and popular science texts from her time working at research funding foundations.