Legal advice on a medical experiment for a U.S. nicotine company

Our Law Firm has taken care of the operation of a large company producing new type e-cigarettes based in the USA. The company is guided by both high professional ethics and quality. Many customers and experts have gained the trust of many customers and experts with their approach to the industry. It boasts numerous certificates that certify the high quality of its services.

Our client plans to launch an innovative type of e-cigarette on the American market. For a product to be approved for use, it must be approved by the FDA. To obtain data on the properties of e-cigarettes that are necessary for the application, the company plans to conduct studies on a group of volunteers. A medical experiment to test the activities of the new type of e-cigarettes will be carried out by a Polish research unit, accredited by the FDA.

The Law Firm advises comprehensively in the process of preparing a medical experiment, making sure that the documents submitted to the competent authorities of the medical authority and documents submitted to the administrative authorities meet all the requirements provided for by Polish and European law. The Law Firm also ensures compliance with the rules on the protection of personal data as part of the research and conducts ongoing legal services of the cigarette manufacturer related to the experiment.