Our unique approach and experience enable us – together with our clients – to develop short- and long-term strategies related to the day-to-day management of business operations, company growth, product development, and crisis management. The projects we advise on include: distribution models for medicinal products in Poland and international markets, activities of parallel importers within the European Union, importation of medicinal products for rare diseases into Poland, cooperation with contract manufacturers located outside the European Union, acquisition or sale of pharmaceutical sector companies holding regulatory authorisations and permits (e.g. wholesale distribution authorisations or marketing authorisations), production of dietary supplements in accordance with GMP standards, import and export of medicinal products from third countries.

We prepare comprehensive legislative analyses and studies relating to the current practice of regulatory authorities in Poland. We also issue legal opinions analysing regulations in light of specific factual circumstances, addressing clients’ questions and presenting, in a concise manner, possible next steps or recommended courses of action.

We provide regulatory advice covering every stage of a medicinal product’s lifecycle, including research and development (R&D, clinical trials), registration procedures, placing products on the market and distribution, post-authorisation changes, and ongoing regulatory compliance. We support clients in cases involving suspension or withdrawal of medicinal products from the market – alongside fulfilling regulatory obligations, we develop further action plans aimed at clarifying the situation and minimising risks related to product unavailability.

We conduct quality audits at medicinal product manufacturing sites and pharmaceutical wholesalers, assessing compliance with applicable legal requirements. Audits are carried out at our clients’ premises or, on their behalf, at the facilities of subcontractors and contract manufacturers. Our experience includes conducting audits not only in Poland and other EU Member States, but also in Asia and North America.

We represent clients in proceedings before administrative courts and civil courts. Our experience covers not only matters directly related to regulated activities, such as obtaining permits, authorisations and licences, as well as post-inspection, registration and reimbursement proceedings. We also represent clients in customs and fiscal proceedings, matters relating to environmental protection law, as well as in cases concerning contractual liability and disputes with business partners.

We offer comprehensive support to entities placing food products and dietary supplements on the market. We assist clients in dealings with regulatory authorities, review product compositions, packaging designs and advertising materials, and conduct proceedings before sanitary inspection authorities.