CEE/CIS - Poland
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Healthcare and life sciences

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Kieltyka Gladkowski KG Legal

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The offering at Kieltyka Gladkowski KG Legal is well-equipped to handle matters involving clinical trials, with a strong emphasis on regulatory and commercial issues. The team often assists with the registration of software as a medical device. Małgorzata Kiełtyka is well-known for her vast knowledge of procedures for market entry, advertising issues, and mandates concerning labelling, while Jakub Gładkowski stands out due to his longstanding experience in joint ventures and M&A, in addition to investments.

Legal 500 Editorial commentary

Testimonials

Collated independently by Legal 500 research team.

  • ‘Quality legal advisory combined with international expertise and industry sector understanding.’

  • ‘Kieltyka Gladkowski KG Legal’s team stands out for its deep expertise and tailored support in the healthcare and life sciences sectors, which has proven invaluable to Austrian companies operating in the Polish market. What sets this practice apart is its client-focused approach, combining a comprehensive understanding of Polish, EU, and international healthcare regulations with a commitment to delivering practical solutions in this highly regulated field.’

  • ‘The team excels in providing precise and timely advice on complex regulatory matters, ensuring that businesses stay compliant with evolving healthcare and life sciences legislation, such as marketing authorisations, clinical trials, pharmacovigilance, and product liability. Their ability to navigate the intricate web of compliance requirements, including medical device and pharmaceutical regulations, is remarkable.’
  • ‘Compared to other firms, KG Legal demonstrates an unmatched combination of legal rigour, scientific understanding, and accessibility, making them a top choice for businesses looking for knowledgeable and efficient legal partners in the healthcare and life sciences industry. They provide not just legal advice, but actionable solutions that help clients navigate the unique challenges of the industry with confidence.’

  • ‘Jakub Gładkowski is a standout legal professional. His ability to navigate complex cross-border transactions, regulatory compliance, and litigation within these industries sets him apart from his peers. Jakub's remarkable skill set spans a broad range of issues, from negotiating international contracts in life sciences to advising on regulatory compliance related to clinical trials, pharmacovigilance, and medical devices.’

  • ‘Małgorzata Kiełtyka is an exceptional legal professional. Her thorough and insightful approach to cross-border matters—both contentious and non-contentious—makes her an invaluable advisor for clients dealing with high-stakes legal challenges. Her deep understanding of life sciences regulatory frameworks, especially in pharmaceuticals, medical devices, and healthcare technology, is unrivalled.'

  • ‘True international focus in jurisdiction where it can prove challenging to find law firms focused on international clients.’

  • ‘Jakub Gładkowski and Małgorzata Kiełtyka have a genuine international focus and both of them are extremely active.’

Key clients

  • BioLaw Europe
  • Life Science Cluster Poland
  • Advantage Austria

Work highlights

  • Advised an international client on clarification with the Polish medicine regulatory office of the post-clinical trial duties of the sponsor of innovative genetic drug to provide medicinal products and the procedures for compassionate use.
  • Advising an American client on EU Regulations 745 and 746 on the classification of software as a medical device for in vitro diagnostic procedures, where the status of the product is complicated by modern AI computational functionality enabling the prediction of a disease in a healthy patient over a 10-year period.
  • Advised an American trader on the introduction of high-quality Korean skincare cosmetics and novel food to the e-commerce retail market, including panax ginseng extract from organic DMZ farming, and in addition to regulatory requirements, the firm ensures the performance of the obligations of the responsible entity and all customs and transaction security issues.

Lawyers

Leading partners
The strongest partners in their field, leading on market-leading deals and endorsed by peers and clients alike.
Małgorzata Kiełtyka
Kieltyka Gladkowski KG Legal

Practice head

The lawyer(s) leading their teams.

Małgorzata Kiełtyka, Jakub Gładkowski