Małgorzata Kiełtyka
Kieltyka Gladkowski KG LegalKieltyka Gladkowski KG Legal maintains its stellar reputation for handling technology-related issues within the medical devices industry, regularly assisting distributors with EU and Polish marketing requirements, and bio-pharma companies with obtaining approval to market biosimilars in Poland. Dividing her time between Kraków and Warsaw, the ‘outstanding’ Małgorzata Kiełtyka leads the team alongside the ‘excellent’ Kazimierz Jakub Gładkowski. Kiełtyka is well placed to advise on a broad range of transactional and regulatory issues across the sector, including labelling and advertising, distribution channels, and entry procedures. Gładkowski has deep knowledge of issues related to clinical trials, frequently assisting clients with pharmacovigilance issues.
Legal 500 Editorial commentary
Testimonials
Collated independently by Legal 500 research team.
- ‘What sets this practice apart is their comprehensive knowledge of the industry. Their expertise spans a wide range of areas, including pharmaceuticals, medical devices, clinical research, and regulatory compliance. This in-depth understanding enables them to provide tailored solutions that align perfectly with the unique needs and objectives of clients.’
‘Kazimierz Jakub Gładkowski and Małgorzata Kiełtyka exemplify excellence and distinction in the legal field. With their extensive experience and diverse specialisations, they offer clients a level of legal counsel that is truly exceptional.’
‘Kazimierz Jakub Gładkowski stands out as an excellent lawyer.’
‘Małgorzata Kiełtyka and Kazimierz Jakub Gładkowski are extremely experienced in the field of life sciences, and are able to handle complex matters even under time constraints.’
‘Kazimierz Jakub Gładkowski is my main contact. He is a real pleasure to work with, pragmatic and knowledgeable. ’
‘Highly professional in legal practice, with a track record in healthcare, life sciences and medical device projects.’
‘Małgorzata Kiełtyka and Kazimierz Jakub Gładkowski are outstanding professionals in the life sciences sector.’
‘Kazimierz Jakub Gładkowski and Małgorzata Kiełtyka are both very high skilled lawyers, each with their own specific qualities, they are both very smart and are highly experienced and skilled in healthcare and life sciences.’
Key clients
- BioLaw Europe
- Life Science Cluster Poland
- Advantage Austria
Work highlights
- Advised a US corporate investor on the protection of the activity of the client's retail market share of medicines.
- Acted for a client in defence litigation concerning an allegedly defective medical device.
- Advised the global manufacturer of a drug whose final dose is sold in disposable dispensers on information obligations in the leaflet attached to the medicinal product.
Lawyers
Leading partners
The strongest partners in their field, leading on market-leading deals and endorsed by peers and clients alike.
Practice head
The lawyer(s) leading their teams.
Małgorzata Kiełtyka, Kazimierz Jakub Gładkowski