Life Science & Healthcare

The health care sector exhibits a high degree of regulation at both the Polish and European levels. Our law firm offers comprehensive legal support to companies in this sector, including drug manufacturers, medical facilities, medical device manufacturers, pharmacy owners and investors. We serve domestic and foreign clients, providing strategic advice tailored to the specifics of the industry. Our goal is to support clients in providing cutting-edge services, using our experience and interdisciplinary knowledge to meet the challenges of the rapidly changing legal and market environment in the health care sector. Competent legal services avoid many risks.

We work with pharmaceutical companies and medical device manufacturers, offering comprehensive legal support for new product launches and promotions. We assist in obtaining the necessary permits and represent clients before the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. We provide ongoing legal support, as well as in court and administrative proceedings.

We specialize in serving the medical industry, offering a wide range of legal services tailored to the needs of medical entities and medical professionals. We support clients from registration to business transformation, and offer ongoing advice to hospitals, clinics, dispensaries and practices and other medical entities on medical law and civil law aspects of operations. We also represent our clients in litigation related to the provision of medical services.

The scope of our law firm’s consulting services includes:

• Medical and pharmaceutical law: We represent clients before the Chief Pharmaceutical Inspector, the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products and the Minister of Health, as well as before administrative courts.
• Obtaining permits and notifications: We assist in obtaining marketing authorizations for medicinal products and medical device notifications. We prepare legal opinions and expert reports.
• Production transfer: We help formalize the transfer of drug and medical device production to other facilities through company conversions and formal notification of production transfers.
• Registration and reorganization of medical entities: We provide comprehensive legal services for the registration and establishment of medical entities and advise on reorganization and restructuring processes, providing support at every stage.
• Litigation: We represent medical entities in reimbursement disputes with the National Health Fund and in civil and criminal cases involving medical errors.
• Clinical trials and research and development projects: We offer support for clinical trial projects and research and development projects.
• Protection of industrial and intellectual property rights: We support the medical industry in obtaining patent protection, trademark registration, protection of works, know-how, and utility and industrial designs.
• Promotion and advertising of pharmaceutical and medical products: We provide legal advice on the compliance of marketing activities with the law, evaluating marketing practices and assisting in the implementation of promotional campaigns.
• Public Procurement Law: We have extensive experience in the area of public procurement law, supporting clients in the development of tender documents and carrying out procedures for selecting the best offer. 
• Audit of operating facilities: We conduct audits of medical entities already in operation, identifying areas for improvement and proposing specific solutions to improve efficiency and compliance with applicable regulations, including data protection regulations.
• Ongoing service to medical facilities, pharmaceuticals and pharmacies: We provide ongoing legal advice to drug and supplement manufacturers, hospitals, medical facilities and pharmacies, supporting them in their day-to-day operations and establishment process.

Experience:

The firm’s long-standing clients include Polish factories of global manufacturers, suppliers of medical equipment, medical devices and integrated solutions and systems used in medical care. In addition, our services are used by medical and pharmaceutical companies involved in the distribution of medical devices, dietary supplements and specializing in promotional activities for medicinal products and dietary supplements. The law firm’s clients also include entities providing medical assistance and treatment activities.

We assist our clients with both day-to-day legal advice and more complex projects requiring a customized approach. We also keep clients informed of changes in the law. Such comprehensive assistance is possible thanks to our multidisciplinary team, which combines various fields of law with in-depth knowledge of the specifics of the industry.