Sophie Bertilsson Senior consultant
PhD
sophie.bertilsson@regsmart.se
+46 (0)733 – 91 66 30
Sophie has broad experience of the pharmaceutical aspects of drug development. She has over 15 years of experience as project manager as well as expert in the pharmaceutical industry, where her main focus areas have been development and GMP manufacturing of active pharmaceutical substances, drug product supply to clinical trials, and regulatory CMC aspects. The regulatory expert role included development and implementation of global regulatory CMC strategies for projects up until market approval, authorizing regulatory documentation, interactions with health authorities as well as activities related to in- and out- licensing.
Most recently, Sophie comes from the Swedish Medical Products Agency, 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.
Sophie has experience of a wide variety of drug formulations and has also assessed new chemical entities.
She has a special interest in impurities and new manufacturing methods.