CGU s. r. o.

Full-package solutions and representing in regulatory affairs with respect to medical devices 25+ years in the business

Near-zero submission rejection rate

Submissions approved in under 20 days 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

+421 904 150 444

Business name: CGU s r o Registered address: Sreznevského 10, 831 03 Bratislava, Slovakia Identification number: 47 563 613 Registration: District court Bratislava I, file no 97093/B, section Sro VAT ID: SK2023969310