Karolina Fijałkowska
managing associate, attorney-at-law
Karolina is an attorney-at-law specialising in pharmaceutical and food law, as well as life sciences regulatory matters.
She advises clients across the pharmaceutical, medical and food sectors on regulatory requirements, market access - including reimbursement - advertising, and compliance with applicable laws and regulations. She has extensive experience gained both in private practice and as an in-house lawyer in the pharmaceutical industry, which allows her to combine legal advisory expertise with a strong understanding of business realities, further supported by postgraduate studies in healthcare business management.
She has been involved in projects covering the full product lifecycle - from clinical development and registration, through distribution and marketing, to proceedings before regulatory authorities. She represents clients before key regulatory bodies, including the Main Pharmaceutical Inspectorate (GIF), the Chief Sanitary Inspectorate (GIS), and the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL).
Her practice focuses on comprehensive regulatory advice relating to medicinal products, medical devices, food supplements and cosmetics, with particular emphasis on regulatory risk management. She also advises on intellectual property matters, in particular in relation to agreements concerning the use of works and related rights, including audiovisual productions, cooperation with creators, and issues related to the exploitation and protection of rights. She also delivers training and supports clients in designing and implementing compliance frameworks.
Languages: Polish, English
email: k.fijalkowska@kclegal.eu