We have been participating in the field of clinical trials since 2007 and the members of our team are therefore among the longest continually operating legal advisors in the particular field of law in the Czech Republic. Having acquired unique know-how in the course of our long-term cooperation with established CROs, we are able to provide our clients with expertise beyond expectations. we use in providing legal services for our clients.
- Comprehensive legal services related to clinical trials (drafting of contractual documents for the cooperation with the centres, examining doctors and other persons taking part in the clinical evaluation, the negotiation of conditions, communication with State Institute for Drug Control and ethical committees, insurance of the clinical evaluation),
- turnkey establishment of a branch of a foreign CRO including the issuance of the relevant permissions and employment matters,
- legal services related to the registration of medicinal products, preparation of SPCs,
- legal advisory with respect to the introduction of dietary supplements and medical devices onto the market in the Czech Republic (advertisement regulation, claims made on products, auditing of online presentation etc.).
Worldwide clinical trials