Firms To Watch: Healthcare and life sciences

CMS Cameron McKenna Nabarro Olswang Posniak i Bejm sp.k.'s life sciences team advises clients on regulatory issues and product development and promotion, as well as corporate transactions.
Boutique life sciences firm DBS Law has particular expertise in pharmaceutical, medical devices, food, and reimbursement law engagements, as well as orphan drug mandates.

Healthcare and life sciences in Poland

Czyzewscy Kancelaria Adwokacka

Reimbursement of medicinal products and the pricing, advertising and promotion of healthcare services and products are areas of expertise for the life sciences team at Czyzewscy Kancelaria Adwokacka, a boutique firm with a focus on healthcare and life sciences. The team is also adept at assisting pharmaceutical companies in building up their compliance systems. Founding partner Katarzyna Czyżewska is head of the practice and is often involved in public consultations on law changes; she also focuses on pricing and reimbursement matters. Maciej Huzior and Karol Piekarczyk are also names of note.

Practice head(s):

Katarzyna Czyżewska

Other key lawyers:

Maciej HuziorKarol Piekarczyk

Testimonials

‘This is a boutique firm but with a sound knowledge of the pharma industry. Strongly client oriented and very pragmatic.’

‘Katarzyna Czyzewska is always very helpful. Sha makes herself always available and always gives very specific and pragmatic advice. She also knows extremely well the pharma industry.’

‘Katarzyna Czyzewska is a very trustworthy partner: always engaged and reliable, taking care about the details, understanding the client’s needs and very practical.’

‘The team at Czyzewscy kancelaria adwokacka is supportive and experienced, and their legal advice is valuable, based on a very good knowledge of the Polish life sciences market and law.’

‘They present a model customer approach, always being open to modify the offer if needed and to provide required support in needed time. The lawyers from that law firm always aim to find solutions fitting to the needs of client, presenting client oriented approach. The advice is practical, catching the major points of client’s concerns, not being too general or wordy.”

‘Katarzyna Czyzewska has a wide knowledge, not only of widely understood pharma law, but the whole industry which significantly improves the advice she gives. She is absolutely exceptional in terms of client approach – always open to plan the work meeting the clients’ needs (in terms of the granularity, fee arrangements and timing).’

Key clients

Izba Gospodarcza “Farmacja Polska”

Sanofi Group

Servier Polska

Pfizer

Advanced Accelerator Applications

Klosterfrau

CSL Behring

INFARMA

Thea

Oriflame

Work highlights

  • Advised Izba Gospodarcza “Farmacja Polska”, as well as other clients, on the currently processed changes in the Polish Reimbursement Law.
  • Assisted a pharmaceutical company in several proceedings concerning reimbursement of medicinal products.
  • Advised several clients on compliance in pharmaceutical companies through webinars.

DLA Piper Giziński Kycia sp.

The ‘truly outstanding‘ life sciences team at DLA Piper advises on regulatory and product liability mandates across a range of life science sectors, including pharmaceutical, medical devices, food and healthcare. The group is also active in telemedicine, representing companies marketing cardiovascular and neurological drugs and devices. Andrzej Balicki heads up the team and advises on both Polish and EU regulation matters regarding medicinal devices, pharmaceuticals, diet supplements and healthcare services. Senior associate Jolanta Dąbrowicz advises manufacturers and distributors of medicinal products and devices on regulatory and contentious issues.

Practice head(s):

Andrzej Balicki

Other key lawyers:

Jolanta Dąbrowicz

Testimonials

‘Truly outstanding life sciences team. Great understanding of the market combined with pragmatic approach. Top-notch team for all sector-related matters. Emphasis on diversity and the spirit of internal collaboration are clearly visible.’

‘The team is highly experienced in life science regulatory, distribution and procurement matters. They really understand all practical, legal and business aspects of distribution of medical products. They support us on both legal and business aspects.’

‘The team is simply outstanding. Top pharma team on the Polish market. Highly responsive and providing pragmatic solutions. Always keeping track with new regulatory developments. I like their approach to diversity; it is a very strong value that is clearly visible in their daily practice.’

‘DLA Piper’s team helps their pharmaceutical clients in regulatory and contractual matters. The team are committed professionals. Always ready to advise their customers. They are knowledgeable advisors, very business-oriented, easy to reach and supportive. The team supports us comprehensively in creating a model of distribution and marketing for a new product we intend to place on the Polish market.’

‘Andrzej Balicki has extensive experience in advising the life sciences sector and is highly respected in the industry. He is a creative and client-focused problem solver. He is certainly a leading regulatory lawyer in Poland. The other team member Jolanta Dabrowicz works closely to the client and shows experience in regulatory and contractual matters.’

‘Andrzej Balicki is a clear leader of the team and is my first contact point in all matters. He is very energetic, pragmatic and solution-oriented. Andrzej has market-leading regulatory knowledge. He has great understanding of legal and business aspects of public affairs projects. Andrzej is known for his strategic thinking and ability to implement it in practice.’

‘Andrzej Balicki – extensive experience in advising the pharmaceutical sector and is respected in the industry. He is a creative and client-focused problem solver.’

‘Jolanta Dabrowicz works closely with the client and shows experience in pharmaceutical and contractual matters.’

Key clients

Abbott

Allergan

Brass Research and Development

Clinmark

Ipsen

Kartos Therapeutics

Life Healthcare Group

Phibro Animal Health Corporation

Philips

Polpharma

Respiromix

Smith & Nephew

UCB Pharma

URGO Laboratoria Polfa Łódź

USP Zdrowie

Tymofarm

Żabka

Vedim

Work highlights

  • Advised Krajowa Rada Suplementów i Odżywek (KRSiO)(Polish Council for Supplements and Nutritional Foods) on the Ministry of Health’s legislative plan to introduce the so-called sugar tax.
  • Advising Tymofarm on a complex project aimed at introducing to the Polish market a newly registered herbal medicinal product.
  • Advising Kartos Therapeutics on clinical agreements templates used in Poland.

Domanski Zakrzewski Palinka

Domanski Zakrzewski Palinka‘s life sciences practice has ‘exceptional pharmaceutical market knowledge‘. The team provides daily legal support to its clients, as well as advising on projects, strategic matters, M&A transactions and regulatory issues. The team benefits from the strength of the firm’s M&A, IP, infrastructure, capital markets, labour law and dispute resolution teams. Michał Czarnuch leads the group with expertise in healthcare law. ‘Excellent advisor’ Tomasz Kaczyński has extensive experience in the pharmaceutical industry, Anna Partyka-Opiela acts as an in-house counsel for pharmaceutical companies and Marcin Pieklak advises clients on the financing of drugs, medical devices and food supplements from public funds.

Practice head(s):

Michał Czarnuch

Testimonials

‘Very good team of lawyers that can offer a pharmaceutical company multi-disciplinary assistance in a variety of fields of law for competitive fees. Especially good for a retainer to help with day-to-day work.’

‘The team has fast responsiveness, good involvement in legislation activities, supports pharma-market organisations, has very good collaboration and creates an atmosphere of trust with an experienced team.’

‘Exceptional pharmaceutical market knowledge and very good understanding of business. Very good knowledge about “working solutions” on the market, very good knowledge concerning NHA expectations and requirements.’

‘Marcin Pieklak has unique and broad experience on reimbursement law, particularly useful in shaping Risk Sharing Schemes and / or offering value during reimbursement negotiations.’

‘Tomasz Kaczyński is an excellent advisor for distribution set-ups for the pharmaceutical sector. He combines an understanding of business needs with legal and regulatory risk mitigation.’

Key clients

MSD Polska sp. z o.o.

Teva Pharmaceuticals Polska

Pfizer Polska sp. z o.o.

GSK

AstraZeneca Pharma Poland Sp. z o. o.

Telemedicine Working Group

Mylan Healthcare sp. z o.o.

Astellas sp. z o.o.

Takeda Sp. z o.o.

Infarma. The Employers’ Union of Innovative Pharmaceutical Companies

Polish Federation of Hospitals

Sanofi Aventis Sp. z o.o.

Bayer Sp. z o.o.

Super-Pharm Holding

Intervet

Servier Polska Sp. z o.o.

Glaxosmithkline consumer healthcare Sp. z o.o.

AbbVie Polska Sp. z o.o.

Olimp Laboratories Sp. z o.o.

Home Doctor sp. z o.o.

UCB Pharma Sp. z o.o

Kieszkowska Rutkowska Kolasinski Kancelaria Prawna sp. j.

The healthcare and life sciences department at boutique firm Kieszkowska Rutkowska Kolasinski Kancelaria Prawna sp. j. supports businesses operating in regulated markets, such as the pharmaceutical, medicinal, food and cosmetic sectors. The team also increasingly advises on mandates regarding new technology such as AI and e-Health. Paulina Kieszkowska-Knapik and Ewa Rutkowska jointly lead the team. The team has undergone changes with the addition of senior associates Michał Tracz, who has expertise in food and cosmetic law from Domanski Zakrzewski Palinka in September 2020, and Bartłomiej Sasin, who specialises in pharmaceutical and medical law, from Kancelaria Tomasik Jaworski in April 2021. Michał Chodorek was promoted to partner in June 2021. Natalia Łojko and Agnieszka Zielińska-Krywoniuk left the firm in early 2021.

Testimonials

‘Diversity is a very strong asset of the team. This is a boutique law firm, with great specialists in place. I think that what makes it special is also their pro bono work, especially for patients and patient organisations. The team is full of energy with a business approach.’

‘KRK law firm has a number of seasoned legal experts that have deep understanding of the market and legal environment makes this law firm special in the field they operate in. The expertise coming from KRK is based on a very practical approach to the cases they work on, deep legal expertise and excellent understanding of the market dynamics.’

‘We have worked with KRK for many years for the simple reason that this is one of the best Healthcare practices in the Polish market. They are real experts in the field, very flexible, professional and open-minded. They promptly respond to our requests. We can rely on them; we simply trust their legal and business-based solutions. Last but not least, they are very pleasant to work with.’

‘I had the opportunity to cooperate with Paulina Kieszkowska-Knapik and Michał Tracz. Both are undoubtedly high-class experts in their specialization.’

‘Paulina Kieszkowska-Knapik is a legal authority in this field, she is well versed in the attitude of regulatory authorities, therefore the advice provided by her ensures not only full legality of the applied solutions but also efficient handling of cases.’

‘Michał. Tracz is a very effective proactive lawyer who not only advises, but also anticipates the client’s needs, suggesting topics that should be paid attention to and proposing to deal with them efficiently.’

‘Paulina Kieszkowska Knapik is an undisputed leader in pharma law in Poland, always advising to the point and delivering the advice exactly in granularity asked by the client. Paulina’s knowledge on reimbursement law and the practicality of her advices make her exceptional.’

‘Ewa Rutkowska is an outstanding litigation lawyer, specializing in, among other areas, in product liability. She presents a comparable, outstanding knowledge of the pharma industry and law.’

Key clients

The Employers’ Union of Innovative Pharmaceutical Companies

Work highlights

  • Advising INFARMA on key legal topics, such as the Reimbursement Act and Pharmaceutical Law, the Act on the Prevention of Infections and Infectious Diseases, new Clinical Trials Law and the new Medical Devices Act.
  • Advising a global innovative pharmaceutical company on both strategic and day-to-day assistance in the process of changing the client’s distribution setup in Poland.
  • Advising on a client’s involvement in cooperation with pharmacies and its sales of medicinal products online.

Eversheds Sutherland Poland

The life sciences team at Eversheds Sutherland Poland is led by regulatory and product safety specialist Marta Gadomska-Golab and consumer law expert Aleksandra Kunkiel-Kryńska. The team handles advisory matters concerning commercial and regulatory mandates for domestic and international clients. This includes product compliance, safety and registration, and the team also has expertise in Polish clinical trials. The group was bolstered by the 2021 arrivals of Jowita Prokop from Domanski Zakrzewski Palinka and Martyna Gałdecka from Crido Legal.

Other key lawyers:

Jowita ProkopMartyna Gałdecka

Testimonials

‘Fast and reliable feedback. Detailed oriented and engaged team.’

‘Always available and easy to reach legal partners with business-oriented attitude able to deliver custom made advice that takes into consideration business and marketing needs.’

‘Openness to client’s needs, ability to identify the specific legal needs and deliver customised, reliable, professional legal advice was highly appreciated.’

‘Very fast and reliable service. No delays even in cases of very short deadlines.’

Key clients

Aspen Pharmaceuticals

Pharmacy Solutions

Sinclair Pharmaceuticals

Edwards Lifesciences

LifeFlow

Medicare Galenica

Polish Coalition for Personalised Medicine – Association

Samsung

Telemedico

Allecco

Gdziepolek

Work highlights

  • Advised Aspen Pharmaceuticals on regulatory matters and distribution models for pharmaceutical products, especially regarding the Direct-to-Pharmacy distribution business model.
  • Advised Sinclair Pharmaceuticals on setting up its pharmaceutical operations in Poland.
  • Advised Samsung on all regulatory aspects as well as the promotion and advertising of a medical device.

NGL Legal

The products and health team at NGL Legal consists of individuals previously with Hogan Lovells (Warszawa) LLP. Life sciences regulatory and compliance matters, as well as internal investigations, clinical trials and product liability disputes for medical device companies, are core areas of focus for the team. The practice is led by Agnieszka Majka; senior associate Celina Bujalska and associate Anna Wiktorow-Bojska are also notable team members.

Practice head(s):

Agnieszka Majka

Testimonials

‘Very analytical and detailed focussed.’

‘The Healthcare and Life Sciences Team is extremely substantive, quick and friendly. Such a combination on the Polish legal market is infrequent. Not only do they do a very good job, but they do it gracefully and in a way that is most convenient for clients. They are ahead of technological solutions that facilitate the work of the clients.’

‘Highly experienced in the life sciences sector; works well with international clients.’

‘Agnieszka Majka is unique from the beginning of her career. She can perfectly listen to customers and sense their needs, sometimes better than themselves. Celina Bujalska is following in her footsteps and there is no unresolved legal issue for her. Anna Wiktorow-Bojska is the fastest working associate ever. She is in the first league in terms of legal analysis of the complex product law issues.’

‘Agnieszka is great.’

‘Agnieszka is a hard worker and clients love her.’

‘Agnieszka Majka is highly specialized in compliance and investigation matters in the life sciences sector and is very responsive.’

Key clients

Fundacja K.I.D.S. Klub Innowatorów Dziecięcych Szpitali

Zimmer Biomet

Work highlights

  • Advising a global pharmaceutical company and its affiliates on various areas of law in different European jurisdictions, including but not limited to CEE and the Baltic States.
  • Advising two leading manufacturers of medical devices on product liability matters consisting of claims for damages and compensation due to bodily injury caused by an alleged defect in the products.
  • Assisting in clinical trials, including drafting and reviewing clinical trial agreements, advice related to the scope of liability in clinical trials, advertising and compliance.

Soltysinski Kawecki & Szlezak

Soltysinski Kawecki & Szlezak‘s practice focuses on pharmaceutical law and medical devices, food law, biocidal products, IP and public procurement. The team handles regulatory matters, product labelling advertising and promotion, and is also increasingly involved in clinical trials. The team is jointly led by IP and life sciences experts  Jacek Myszko  and Ewa Skrzydło-Tefelska. Marcelina Izydorczyk is also a name of note.

Other key lawyers:

Marcelina Izydorczyk

Testimonials

‘The team has good knowledge regarding the regulatory requirements and also commercial aspects in Poland.’

‘Very well organised team demonstrating exceptional listening skills to understand and meet client expectations.’

‘Extensive experience of lawyers, focus on solutions and a great variety and scope of the team is an additional advantage that the law firm can take advantage of.’

‘Excellent knowledge in the area of life sciences and biotechnology in Poland, focusing on contractual, compliance and data privacy issues, especially the implementation of the EU General Data Privacy Regulation (GDPR) in Poland.’

‘Jacek Myszko gives very practical advice, demonstrating an in-depth knowledge of biotechnology and life sciences in Poland, business acumen, and was always available when we needed him.’

‘Marcelina Izydorczyk is a thorough, diligent and very adaptable and creative lawyer, capable of resolving intricate issues quickly and effectively.’

‘Jacek Myszko is the lead partner for our company. He is extremely responsive, dedicated, knowledgeable and efficient. We really appreciate the work that he and his team do for us.’

‘Ewa Skrzydło-Tefelska and Jacek Myszko have great knowledge and focus on answering customer questions and challenges. They get a quick understanding of the industry challenges and provide highly helpful feedback and advice. In difficult matters and more complicated matters, point-to-point advice is very helpful.’

Key clients

Technicolor Home Entertainment Services, Inc.

PSI Pharma Support Poland Sp. z o.o.

E&J Gallo Winery

Dr. Max Pharma s.r.o.

Nesperta Sp. z o.o.

Polski Związek Pracodawców Przemysłu Farmaceutycznego

Work highlights

  • Advised Technicolor Home Entertainment Services Inc. on an agreement with Bacteromic dealing with the manufacturing of a state-of-the-art medical device for in vitro diagnostics.
  • Advised Genomic Health Inc. in all aspects of running an observatory study in Poland.
  • Advised EJ Gallo on a number of regulatory projects regarding launching on the market, including the formulation and labelling of products in Poland and the EU.

Baker McKenzie Krzyzowski i Wspólnicy Sp.k.

The healthcare and life sciences team at Baker McKenzie Krzyżowski i Wspólnicy Sp.k. is spread across Warsaw and Łódź, providing advice on regulatory, reimbursement, distribution and advertising matters. In particular, the group has expertise in drug approval procedures and M&A transactions and projects. Corporate lawyer Paweł Hincz leads the practice and is supported by senior associate Juliusz Krzyżanowski, who has ‘excellent expertise in pharmaceutical law', and associate Marcin Fiałka.

Practice head(s):

Paweł Hincz

Testimonials

‘Renowned team of reputable lawyers with good cross-functional co-operation. Good understanding of the market and credible in advisory work.’

‘I have been working with this practice on one project and their professionalism and experience were outstanding, I would truly recommend it to anyone looking for support from this area.’

‘The healthcare practice is very helpful and open to creative collaboration, supportive in everyday work and I can contact one lawyer for all matters related to legal support of the company.’

‘I’ve worked with Baker McKenzie on several high profile projects. I value their professional and business-oriented approach and that their advisory is always suited for our purposes, not generic. Recently, they have advised us on distribution contracts, analysis on sales activities, compliance matters and training and regulatory pharma questionnaires.’

‘I usually work with Juliusz Krzyżanowski. He is an excellent lawyer. The legal advice is always helpful and practical. He also has a great strength in providing valuable information pro-actively, which I highly appreciate. He is very engaged and absolutely reliable.’

‘Juliusz Krzyżanowski has excellent expertise in pharmaceutical law, is dedicated to his work and seeking pro-client solutions. Engaged and ready to help in emergency situations.’

‘I directly work with Juliusz Krzyżanowski, who really understand business, provides alerts and clarifies impact from amended regulations, which allows us to adapt the company on time. He is very responsive and quick.’

‘Juliusz Krzyżanowski is a “go to man” in life sciences cases.’

Key clients

American Chamber of Commerce

Astellas Pharma

Work highlights

  • Advised American Chamber of Commerce within the COVID-19-related legislation process where the Polish Government planned to introduce regulations having negative influence on the functioning of pharmaceutical industry.
  • Advised Astellas on certain life sciences related issues, including direct import of medicinal product for patients, whose medical condition required immediate supply, and liability in clinical trials.

Clifford Chance

The healthcare and life sciences group at Clifford Chance is led by dispute and white-collar crime expert Marcin Ciemiński. The practice handles cross-border strategic transactions, litigation regarding the pharmaceutical sector, medical devices, and life sciences law and regulatory matters. Counsel Paweł Pogorzelski is skilled in corporate compliance matters and litigation, and  advocate Justyna Błazejczyk-Kuwał has experience of regulatory mandates.

Practice head(s):

Marcin Ciemiński

Testimonials

‘This team has broad and deep experience in the industry and a practical approach that makes its advice effective and actionable.’

‘Professionalism, international experience and expertise, especially in the US.’

‘People are involved, attentive, emphatic, patient and delivering more than expected.’

Key clients

Pfizer, Inc.

Dentons

Dentons‘ life sciences and healthcare practice provides regulatory, advisory and litigation services to its clients, including local and international pharmaceutical and biotechnology companies, medical device distributors, drug retailers, pharmaceutical organisations and Polish healthcare providers. Practice head Wojciech Kozlowski is adept at litigation and regulatory matters, and Maria Samolińska-Hojda was recently promoted to pharmaceutical consulting director and specialises in advising on wholesale trade in medicinal products and brokerage of medicinal products. Agnieszka Stefanowicz-Barańska and counsel Adam Odojewski are also names of note.

Practice head(s):

Wojciech Kozlowski

Testimonials

‘Dentons’ team provided comprehensive support in proceedings in all of their various procedural stages, were able to promptly respond to all developments in these proceedings and managed to achieve – on behalf of the client – several very important positive decisions.’

‘Wojciech Kozlowski – appreciated for his hands-on approach, providing both strategic litigation guidance and having a detailed knowledge of all pending cases.’

Key clients

Accord Healthcare

Adamed

Clinico Medical

DOZ

Dr.Max

Eubioco

Fresenius Kabi

Gilead

GlaxoSmithKline (GSK)

Johnson & Johnson

Komtur Polska

Mabion

Merck

Pelion

Perrigo

Pharmapoint

Polpharma Biologics

Sanofi-Aventis

Shire

Super-Pharm

Ziko Apteka

Work highlights

  • Assisting Johnson & Johnson in regulatory aspects of the acquisition of a medicinal product dossier from another major pharmaceutical company.
  • Representing Ziko in defence against the contra legem decision of pharmaceutical authorities who revoked licenses for the operation of the pharmacies.
  • Representing Super-Pharm on the Polish market in an unprecedented court dispute with a shopping mall developer and property manager regarding a lease of premises.

Fairfield

Oskar Luty and Marcin Flak jointly lead the practice at Fairfield, a firm dedicated to the healthcare and life sciences sector. The group advises the full spectrum of clients, including pharmaceutical and medical device companies, professional associations, cosmetic companies and individuals. Marketing, distribution and regulatory strategies are all within the team’s capabilities.

Practice head(s):

Oskar LutyMarcin Flak

Other key lawyers:

Bartosz Świdrak

Testimonials

‘The specific medical products regulations knowledge in relation to legal knowledge is unique on the market’

‘Very professional and helpful team of lawyers. Always looking for the best solutions and focused on the client’s interest.’

‘Fairfield consists of people who are very much into their work. They have very broad knowledge and still search for novelties. We can always rely on their support, opinions and the solutions offered.’

‘A team of lawyers with extensive experience in the pharmaceutical industry. They respond quickly to inquiries, are flexible with their time, and are able to deliver even large training courses in a short timeframe.’

‘Fairfield is a law firm specialising in the field of medical devices and healthcare legal matters. They have a big experience in this field, they follow all legal changes and they have knowledge about legal projects which are under parliamentary works. They are very open to the co-operation with customers and are also reasonably priced.’

‘The law firm specialises in many areas of law in which it is an expert. In particular, this includes medical device law, competition law and public procurement law.’

‘Oskar Luty and Bartosz Świdrak are highly motivated and highly educated with very unique knowledge of the medical devices and pharmaceutical market’

‘Oskar Luty is an excellent, extremely friendly, contactable, and trusted lawyer, with a wealth of knowledge and experience. Oskar’s great value is his ability to adapt his message to the audience, which is why his training courses are valued not only by lawyers, but also by marketing, registration, and distribution departments, even though they often touch on complex subjects.’

Key clients

ZWIAZEK PRACODAWCÓW POLSKIEGO PRZEMYSŁU SPIRYTUSOWEGO

POLMED

Zentiva

Molnlycke

Angelini

Boston Scientific

Accord Healthcare

Merck

Avon

B. Braun

Work highlights

  • Assisting Polmed in initiating and coordinating a legal report regarding the issue of authorised service providers in the field of medical devices.
  • Supporting Zentiva regarding the merger with Alvogen.
  • Assisting Polmed in preparing a report and guide for hospitals regarding the impact of the new regulation 2017/745 on medical devices.

Kieltyka Gladkowski KG Legal

Kieltyka Gladkowski KG Legal has offices in Warsaw and Kraków, and is a healthcare and life sciences law boutique  led by founding partners Małgorzata Kiełtyka, who handles bio-IT projects, and Jakub Gładkowski, who primarily focuses on biotechnology, pharmaceutical and medtech sectors. The team specialises in gene and cell therapies, AI-related matters and clinical trials; in particular, mandates regarding regulation for products entering the Polish market is a strength of the team, thus the work can often have a cross-border element.

Testimonials

‘KG Legal was responsive, engaging and provided exceptional legal guidance on our expansion plan. The partners are knowledgeable, have a broad breadth of experience in the healthcare and life sciences space, and were quite collaborative. We were able to open an office in the EU on schedule, thanks in large part to KG Legal’s guidance and legal expertise.’

‘The team is very flexible and provide high-quality advice even under time pressure. They are extraordinarily service minded and go the extra mile to ensure business oriented deliveries for the client. The founding partners have a deep understanding of their areas of specialisation and, especially for a boutique firm, have an impressive international network of industry specialised lawyers, facilitating efficient coordination in cross-border matters.’

‘Kiełtyka Gładkowski KG Legal are active members in the Life Science sector. We appreciate the information services covering the legal issues relevant for the development of innovative products and services.’

‘The legal as well as the personal quality provided is always very high. The partners are always available, which is very pleasant, especially compared to other firms. With regard to technology, for example regarding communication (calling, video conferences, etcetera), they are very modern and up to date, and it’s noticeable how they always adapt to changing circumstances.’

‘What makes the partners from KG Legal and Mr. Gładkowski and Ms Kiełtyka stand out and different from the rest, is the fact that the quality they provide is always very high, but also – very importantly – the fact that they are flexible, dynamic, responsible and go all the way in their cases and for their clients. Mr. Gładkowski and Ms Kiełtyka form the perfect team where Mr. Gładkowski and Ms Kiełtyka – both experts in Healthcare and life sciences – complement each other perfectly.’

‘We usually work with Mr Jakub Gładkowski, who is ALWAYS ready to provide professional support and ad-hoc advice. He has extended professional experience in the field of new technologies, especially as it relates to the application of Artificial Intelligence in the development of health technologies.’

‘Jakub Gladkowski and Malgorzata Kieltyka are both truly dedicated individuals who are not only skilled lawyers with in-depth commercial understanding of the health care and life sciences industry sectors, but also proactively engage in international law networks to learn and share knowledge and discuss cross-border issues with peers. For example, Jakub has held positions in the board of the BioLawEurope network.’

‘My contacts are Dr. Jakub Gladkowski and Dr. Małgorzata Kiełtyka, who are excellent professionals.’

Work highlights

  • Advised a leading pharmaceutical company and a higher university in Poland in a technology transfer at the 6th level in the scale of technological readiness assessment for legal procedure of development of biological medicines for animals.
  • Advised a US-based biotechnology company on the legality of the marketing authorisation of Advanced Therapy Medicinal Products, including the gene and cell therapy and tissue engineered products, in the European Union, especially having in mind that the marketing authorisation concerned modern production technologies.
  • Advised a US chemical company on preparing a report and legal assessment regarding the legality of obtaining marketing authorisation of biocidal products in the form of genetically modified organisms to control environment based on the legal provisions which as a rule concern marketing authorisation of chemical substances as biocidal products, rather than live organisms.

Kochanski & Partners

The team at Kochanski & Partners handles IP, advertising, data protection, registration of products, employment law and regulatory and corporate matters, as well as representing clients in court and administrative proceedings. Its clients include international and local pharmaceutical companies and manufacturers of medical devices. Pharmaceutical law and distribution expert Krzysztof Zieba leads the team.

Practice head(s):

Krzysztof Zieba

Other key lawyers:

Karolina Jasiulewicz

Key clients

Techdow Pharma Poland sp. z o.o.

Hasco TM

nOvum Fertility Clinic

Krynica Vitamin S.A.

Natural Pharmaceuticals

Ringier Axel Springer Polska

Molecule One sp. z o.o.

Reckitt Benckiser

Work highlights

  • Represented HASCO Lek successfully against its competitor Swiss Pharma International in numerous trademark infringement cases.
  • Represented Ringier Axel Springer Polska successfully in the appeal proceeding before the Main Pharmaceutical Inspectorate related to alleged infringing advertising of a pharmaceutical chain.
  • Assisted Techdow Pharma Poland sp. z o.o. in the transfer of portfolio rights related to a generic product of the Dutch company.

Kondrat & Partners

Kondrat & Partners is an IP and life sciences boutique firm which advises local and global pharmaceutical companies, wholesalers, hospitals and food and cosmetic producers. Core areas of practice include licensing, distribution, manufacturing and consumer protection. The practice is jointly led by pharmaceutical law expert and managing partner Mariusz Kondrat and Justyna Stefańczyk-Kaczmarzyk, who has expertise in both the pharmaceutical and food sectors.

Key clients

Fortis Pharmaceuticals

Soft4You

Unipharm

Phytopharm

Stada Poland

LuxMed

ProCarePlus Pharma

Ambra Group

Colgate-Palmolive

Pharma Point

Medical Inventi

Polski Lek

Orifarm Polska

Nutricia

Bioceltix

Solinea

Fosun Pharma

Pierre Fabre Medicament

Work highlights

  • Advising Fortis Pharmaceuticals on licensing agreements, manufacturing and distribution agreements, quality and pharmacovigilance agreements and trademark protection.
  • Advising Soft4You on online services for healthcare business, in particular for pharmacies, healthcare services and licensing agreements.
  • Advising Unipharm on licensing agreements, manufacturing and distribution agreements, e-commerce of medical devices and dietary supplement, and models of distribution of pharmaceutical products.

Taylor Wessing Poland

Taylor Wessing Poland advises a range of clients, including manufacturers of pharmaceuticals and medical devices, hospital companies and global enterprises. Areas of focus for the team include advice on manufacturing and distribution, licensing and collaboration, corporate transactions and regulatory matters. Plus, the team’s IP expertise is advantageous for handling patent litigation and product liability issues. Przemyslaw Walasek and senior associate Agnieszka Sztoldman lead the team. 

Practice head(s):

Przemysław Walasek; Agnieszka Sztoldman

Key clients

Theramex

Adama Agricultural Solutions

IPD Analytics

Tixon Technology

Adamed Pharma

Perrigo Group

Fresenius Kabi

Biomaxima

Apotex Inc.

Emmes Company, LLC

Work highlights

  • Advised Adamed Pharma on patent matters and complex negotiations regarding the implementation of the innovative IT system in terms of copyright that enhances day-to-day activities and medicines distribution to warehouses and pharmacies.
  • Advising US pharmaceutical company Perrigo Pharmaceuticals on several brand protection matters in Poland, mainly regarding imitation of product packaging.
  • Advising the German company Fresenius Kabi on the preparation, conduct and legal coordination of one of the largest clinical trials currently underway in Poland.