Marika works both as trainer and consultant at Key2Compliance, with a GMP and Pharma focus. She has a scientist background (PhD in Virology) and have more than 10 years of experience in GMP. She has worked in a variety of roles in different industry segments, eg Pharma industry (eg validation, qualification, production processes, aseptic assurance), […]
Anna Sahlholm is employed at Key2Compliance® and has more than 15 years of experience from product and process development in close collaboration with research and within the medical device industry. Anna has worked with research, product development, strategic product management, clinical evaluations, processes for traceability, risk management, quality, and regulatory compliance for a variety of products. Anna’s […]
Susanne Grimsby is employed at Key2Compliance as a senior consultant in the Regulatory Affairs team. Susanne has more than 30 years of experience from the Life Science business of which the last 8 years in the medical device industry. Susanne has holds positions as QA/RA Manager and QA/RA consultant and has also acting in roles […]
Consulting profile will be posted soon.
Oskar Öhman works as a Clinical Development Consultant at Key2Compliance supporting in clinical research and Biometrics activities. Oskar holds a MSc degree in Medical Biotechnology and has a wide range of expertise within Biometrics including Data Management, data analysis, statistical programming, data standards and process development.
Emily Malmberg is employed at Key2Compliance where she works as a consultant in Clinical Development. She has more than 18 years’ experience from life science research with a PhD in Biomedicine from Gothenburg University, Sweden / Mayo Clinic, Scottsdale AZ, USA, and a MSc in Biomedicine from Lund University, Sweden. In addition, she has been […]
Gustav Sundström works as a regulatory consultant at Key2Compliance AB since February 2022. He has more than 14 years of experience from electrical safety testing of medical equipment and laboratory equipment at Intertek Semko. Gustav now works with technical documentation for medical devices and helps clients with electrical safety. Gustav is a member of SEK TK66, […]
Marcus Mellin is a regulatory consultant at Key2Compliance AB since early 2021. He has previously more than 7 years of experience from the medical electrical safety testing industry at Intertek Semko, both as test engineer and as manager of the medical testing laboratory. Marcus specializes in risk management of medical devices and IVDs, as well […]
Kristina Fant (PhD) has been working with biological evaluation of medical devices for the past 11 years. She has extensive experience in testing of medical devices and GLP, from her previous work at RISE (Research Institutes of Sweden) where she has worked as a Study Director and Deputy Facility Manager. She has also assisted the […]
Ph.D. (Biochem.), Post Doc.(Biochem. Eng.), Dipl. BA (Intl. Marketing) Managing Director, Chairman & Founder, ABD Life Sciences Ltd Björn is an entrepreneur with job experience in several areas of the Life Science industry, including R&D, business development and marketing & sales. Björn has worked in a wide diversity of fields, among them molecular biology, molecular diagnostics, bioprocessing, […]