Medicinal products and medical devices regulatory affairs consultants in Slovakia

CGU s. r. o. provides services in regulatory affairs with respect to human medicinal products and medical devices in Slovakia.

We focus on providing full-package solutions for new registrations and all other types of regulatory procedures with respect to human medicinal products (variation procedures, transfers of registrations, etc) and medical devices in Slovakia. We also provide the service of acting as local agents for marketing authorization holders with no representation in Slovakia, which is a statutory requirement under Slovak legislation.

We work with professionals with over 25 years of experience in the industry and with a vast network within the community.

We are proud that our professional work and excellent relationship with the regulator allow us to have near-zero rejection rate of our submissions and our submissions are usually approved in less than 30 days.