Sophie is an expert on chemical/pharmaceutical aspects of drug development.
Most recently, Sophie comes from the Swedish Medical Products Agency (MPA), where she spent four years as a chemistry and pharmaceutical assessor. Her responsibilities included provision of scientific advice, review of clinical trial applications as well as market authorization applications and variations.
She has over 15 years of experience as project manager as well as expert in the pharmaceutical industry, with development and GMP manufacturing of pharmaceutical substances, drug product supply to clinical trials, and regulatory CMC aspects as main areas.
Sophie has experience of a wide variety of drug formulations and has also assessed new chemical entities.
Sophie’s experience within the pharmaceutical aspects of drug development will be a great contribution to broaden the competence and expertise within RegSmart!