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Life Sciences & Healthcare

We advise entities in the life sciences and healthcare sector, including, among others, manufacturers and distributors of medicinal products, veterinary medicinal products and pharmaceutical raw materials, manufacturers of medical equipment, and entities offering healthcare services. We assist our clients in making key decisions to respond to the challenges of the dynamically changing legal and business environment in which the life-sciences industry operates.

We advise on licensing, distribution, product development or manufacturing agreements, providing legal support for business processes from research and development through manufacturing, intellectual property protection and product launch to sales and promotion and advertising activities.

We also support our clients in issues related to compliance with regulatory requirements, anti-corruption regulations and in disputes and court proceedings. We deal with transactional and litigation issues and representation before administrative and regulatory authorities.

Services

  • Providing full legal support for M&A transactions, brand sales, sales and licensing of medicinal products.
  • Advising on the registration, manufacture and marketing of medicinal products.
  • Assisting in creating and implementing sales and distribution structures and strategies.
  • Designing, evaluating and verifying activities in the area of advertising and non-promotional activities.
  • Representing clients in all proceedings conducted under the Pharmaceutical Law Act, the Drug Addiction Prevention Act or the Reimbursement Act.
  • Advising on risk optimization and appropriate organization of pharmaceutical companies, we verify the compliance of applicable procedures and processes with the law.
  • Providing full legal assistance in situations of withdrawal or suspension of medicinal products, suspicion or discovery of corrupt practices and other crisis situations.

Experience

Shenzhen Techdow

Advising Shenzhen Techdow, a leading manufacturer and supplier of the active pharmaceutical ingredient (API), enoxaparin sodium, on its entry to the European market, with the establishment of its European HQ in Poland, the establishing of a European corporate structure encompassing the UK, France, Germany, Spain, the Netherlands and Switzerland, and advising on the entry of products to the market.

Case study

Teva Pharmaceuticals

Advising Teva Pharmaceuticals, the American Israeli pharmaceutical company on its operations in Poland including product advertising, competition matters, and the registration of new products.

Case study

Reckitt Benckiser

Advising Reckitt a British multinational consumer goods company in relation to the marketing and sales of household chemicals, cosmetics, medical devices and medicinal products such as the antiseptic brand Dettol, the analgesic Disprin, the sore throat medicine Strepsils, the indigestion remedy Gaviscon, and the air freshener Air Wick.

Case study

Medicinal Hemp Company

Providing ongoing operational advice to an entity engaged in the import and distribution of medicinal hemp products.

Case study

Medical devices company

Providing support in contacts with the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.

Case study

Pharmaceutial company

Providing legal opinions and memoranda and ongoing legal advice on the basis of the provisions of the Pharmaceutical Law and the Law on Counteracting Drug Addiction.

Case study

Polish distributor of dietary supplements

Providing opinions and negotiating distribution agreements for the leading Polish distributor of dietary supplements.

Case study

Network of specialist medical clinics

Providing transactional advice to a network of specialist medical clinics, in the process of sale of a majority stake held to an entity which is a leader in the medical services industry.

Case study

Shareholders of a pharmaceutical company

Advising on the sale of a block of shares in a company specializing in the sale of pharmaceutical products to a capital investor.

Case study

Polish hemp company

Providing legal support for an entity from the hemp industry in the process of creating a joint venture with the participation of a foreign investor; under the joint venture.

Case study

Team

Our firm consists of nearly 60 people, including lawyers, tax experts and support staff specialising in a range of key practice areas and industry sectors, and located in three offices in Poland.

Malwina Niczke – Chmura

Counsel Warsaw

Rafał Stroiński

Managing Partner at B2RLaw Warsaw

Bogdan Duda

Partner Warsaw

Agnieszka Hajos – Iwańska

Partner Krakow

Paulina Wyrostek

Counsel Krakow

Martyna Szpakowska

Associate Warsaw

Danyila Zubach

Junior Associate Warsaw

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