We advise on clinical trials, market authorisation, regulatory and contractual aspects of distribution and promotion of medicines, and issues of market protection, product safety, and product liability.
We assist clients in delivering products from the lab to the market. We have been engaged in numerous technologies and product solutions. We assist in implementing the requirements under the Medical Device Regulation (MDR) and the In-Vitro Diagnostic Regulation (IVDR), as well as under the national Medical Devices Act and executive regulations governing issues of advertising and promotion of medical devices. We also participate in projects for clinical trials of medical devices.
We advise food companies and producers of functional foods in matters related to market launch, trade and advertising of dietary supplements and foods for special medical purposes (FSMP). We represent clients in disputes before regulators and the administrative courts. We also advise the alcohol, tobacco and hemp industries and retail chains on marketing of various types of consumer goods and in ESG initiatives.
We provide comprehensive legal support for companies operating across the spectrum of the healthcare market. We conduct M&A and compliance projects. We advise on telemedicine and e-health issues.