We conduct ongoing analysis of the impact of dynamically changing regulations on market strategies and the course of mergers and acquisitions, having regard to circumstances such as rising R&D costs, loss of patent protection for popular medicines, price pressure and competition from generic medicines.

At GRK Adwokaci, we represent:

• major national and international pharmaceutical manufacturers (including a number of companies specialising in oncology medicine) 
• medical device companies
• pharmacies 
• R&D entities.

Placing medicinal products on the market
As trusted advisors to large pharmaceutical and biotechnology companies, medical device manufacturers and healthcare providers, we work across practice areas to provide patent protection for healthcare-related brands. 

Our services include: 

• participation in the process of placing medicinal products on the market under the Polish and European procedures
• support in proceedings related to the inclusion of products in the lists of reimbursable drugs and the establishment of their official price
• support in obtaining the relevant manufacturing and marketing authorisations.

Advertising
We also advise on legal and regulatory aspects of advertising and marketing in the fields of:

• healthcare
• life sciences
• clinical research
• competition and commerce.

We provide opinions on the design of advertising campaigns and advertising and information materials for consumers, pharmacies and the medical profession.


Representation before public authorities
Our team provides substantive support and representation in disputes with public authorities overseeing the pharmaceutical industry, including the Chief Pharmaceutical Inspector, the Chief Sanitary Inspector, local sanitary inspection authorities, regional pharmaceutical inspectors and the National Health Fund.

Training
We prepare teaching materials and develop training plans for health professionals: doctors, veterinarians, pharmacists and regional managers, marketing staff and pharmaceutical company managers.


Distribution, pharmacovigilance, marketing agreements
As part of our law firm's activities, we: 

• develop comprehensive pharmacovigilance strategies and reporting procedures
• deal with the preparation of distribution and marketing agreements
• provide consultancy during wholesale distribution and retail sales conducted for pharmacies.