Marketing authorizations, sale and marketing of medicinal products, the activity of pharmacies and pharmaceutical wholesalers, clinical trials – the list of issues subject to stringent regulations is endless. More often than not, handling these issues requires expert legal knowledge.
We help our Clients navigate the complex regulation environment. We solve complicated problems related to data and market exclusivity. We successfully apply our expertise in matters related to pharmaceutical law and industrial property law, clinical trials and liability for failures in clinical trials, and restrictions and bans on advertising, including under European legislation.
We perfectly understand that entrepreneurs need legal advice tailored to the demands of the pharmaceutical sector. Thanks to many years of experience in providing legal services to pharmaceutical companies, our solutions are sound and workable.
• We help our Clients with registration procedures.
• We advise on issues related to data and market exclusivity.
• We handle court proceedings concerning failures in clinical trials.
• We advise on advertising and marketing strategies.
• We draw up expert opinions on matters relevant to the industry.
• We represent Clients in court and administrative court proceedings.
• We help our Clients challenge unlawful regulations as unconstitutional or incompatible with EU law.
• We offer legal services in parallel import cases and advise on the issues at the point of convergence of pharmaceutical law and intellectual property law.
In the pharmaceutical sector, the usual routine is often disrupted when complex challenges arise. When attempting to overcome and understand them, both expertise across various areas of law and a flexible approach are required. Using solutions from abroad as a point of reference, or, as a last resort, calling into question the established domestic solutions, might also be necessary.
Over the years, we have cooperated with pharmaceutical companies with a diverse range of business profiles, handling many different cases. This enables us to solve even the most uncommon problems our Clients face. If it turns out that the case involves patents or there is a risk of infringement of competition law, we provide legal services in these areas, as well.
What sets us apart from our competitors is our professional approach, comprehensive services, and an in-depth understanding of the needs and challenges facing the pharmaceutical sector.
• We offer legal counsel on various matters relevant to the pharmaceutical sector.
• Legal services that our team provides for the pharmaceutical sector also involve matters related to intellectual property law and competition law.
• We have experience in working for manufacturers of both original and generic drugs.
• We are not afraid to implement unconventional solutions.
• We are easily available and offer convenient forms of communication.