Kerstin König is a pharmacist and has over 20 years of experience in the pharmaceutical industry. She has worked both in large international pharmaceutical companies and in medium-sized operations in Regulatory Affairs and has a wide range of expertise. Since March 2022, she has contributed her know-how to regulatory projects for the customers of Quality König GmbH.
Her knowledge covers all aspects of Regulatory Affairs. These include preparing applications for national marketing authorization (including MRP and DCP) and their subsequent maintenance, as well as handling deficiency letters. Kerstin König also has substantial experience with medicinal products authorized under the centralized procedure within German affiliates of international companies, including communication with national authorities.
Working in national and international cross-functional teams is a matter of course to Kerstin König, also in a managerial position. The product portfolios she managed in the regulatory area cover a broad spectrum and include cardiovascular drugs, analgesics, antidiabetics, HIV products and various medicinal products in the area of immunology (monoclonal antibodies). She also has a broad knowledge on a wide range of galenical forms, from solid, semi-solid and liquid dosage forms to solutions for injection or infusion.
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