Pharmaceutical & Health Care

Our in-depth knowledge of the sector enables us to support manufacturers of medicinal products and medical devices, biotechnology companies, clinical trial sponsors, CROs, healthcare providers, pharmaceutical wholesalers, pharmacies, and industry organizations. We combine our knowledge of sector-specific regulations with expertise in intellectual property, competition law, public procurement, personal data protection, new technologies, and corporate law. This enables us to provide comprehensive support for both day-to-day operations and strategic projects and transactions.
Product Launch and Compliance

We advise at all stages of bringing medicinal products and medical devices to market – from registration and post-registration changes to ongoing regulatory counsel. We also assist businesses in obtaining the permits and registrations required to conduct their operations and in ensuring compliance with applicable regulations, including GMP and DPD requirements.

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We advise on product classification and labeling, advertising and promotion, data exclusivity and market exclusivity, patents, supplementary protection certificates (SPCs), parallel imports, as well as reimbursement and public funding for products.

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Distribution and Trade

We advise manufacturers, pharmaceutical wholesalers, and other participants in the supply chain. We support clients in organizing the distribution of medicinal products and medical devices, combating product counterfeiting, addressing issues related to the reverse distribution chain, and navigating export restrictions.

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Clinical Trials

We advise sponsors, CROs, and research sites at all stages of conducting clinical trials. We prepare and negotiate trial documentation, including the CTA and ICF, provide support regarding personal data protection, and advise on managing changes during the trial.

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Healthcare Entities and Digital Transformation in Healthcare

We provide comprehensive services to healthcare entities and medical service providers. We advise on the establishment and reorganization of healthcare entities, as well as on the development of bylaws and business models. We support clients in implementing digital solutions, including those utilizing artificial intelligence, and in the processing of medical data.

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Restructuring and Reorganization, M&A

We support clients in the restructuring and reorganization of entities in the pharmaceutical sector, including mergers, spin-offs, transformations, and the optimization of ownership and operational structures, taking into account the industry’s specific regulatory framework.

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We provide comprehensive support, including due diligence, corporate advisory services, and negotiations, we oversee the entire process through to the full implementation of planned changes, ensuring business continuity.

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We also support our clients in day-to-day matters, such as drafting and negotiating commercial contracts and registration changes.

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Proceedings Before Regulatory Authorities and Disputes

We represent clients before the GIF, the President of the URPL, and other administrative authorities. We handle disputes concerning patent and trademark infringements, as well as acts of unfair competition.

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Regulatory Environment

We monitor legislative changes affecting the pharmaceutical sector, assist clients in assessing the impact of new regulations on their operations, and represent them at Sejm committee meetings. We participate in working groups addressing legal and regulatory issues related to clinical trials. We speak at national and international conferences.

Why us?
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In our work, we emphasize efficiency, transparency, and proper communication.

We understand that we are entrusted with managing strategic projects and are always available. We strive not only to answer questions but also to address the real business needs of our clients.

SK&S lawyers are recommended in national and international rankings (Legal 500, Chambers & Partners, IFLR 1000).