PRACTICE AREA

Food, Drugs and Medical Devices

The Food, Drugs and Medical Devices practice at PRK helps leading pharmaceutical, biotechnology, medical device, food, cosmetics and tobacco firms navigate the complex national and EU regulatory landscape. We advise clients on developing, manufacturing, marketing, promoting and distributing their products.

We also offer support in the area of pricing and reimbursement of drugs, biologics, medical devices and other regulated products. Besides our deep knowledge of the relevant legislation, we maintain a commercial focus and an understanding of our clients' priorities in their day-to-day business operations. We are able to do this in part thanks to the fact that many of our legal experts have themselves spent time working in the industry.

Publications by PRK on the regulation of the pharmaceutical industry

A strong legal team on your side

Miriam Galandova

Partner


Miriam Galandova

Monika Maskova

Partner


Monika Maskova

Jan Augustin

Attorney


Jan Augustin

Elena Cervenova

Attorney


Elena Cervenova

Martin Frolik

Senior Compliance Counsel


Martin Frolik

References

We advised a major pharmaceutical company on the regulation of the pharmaceutical industry, including representing them before the State Institute for Drug Control in administrative procedures to determine maximum prices and dealing with issues related to pricing and reimbursement procedures.

We provided legal advice to a leading pharmaceutical company on the advertising of medicinal products, including helping them during proceedings related to an alleged breach of the industry code of ethics.

We advised a UK company providing clinical research services to the pharmaceutical and biotechnology industry, including reviewing their model contracts for clinical trials.

We advised a leading manufacturer of hearing aids on reimbursement issues.

We have advised various food manufacturers on product labelling.