CGU s. r. o.

CGU s. r. o. is a regulatory affairs firm in Bratislava, Slovakia. It handles registrations for human medicinal products and medical devices, and it acts as local agent for marketing authorisation holders that have no representative in Slovakia.

Services

• Medicinal product registrations: full-package work on new registrations and later procedures for human medicines in Slovakia.
• Medical device regulatory affairs: full-package regulatory work for medical devices in Slovakia.
• Local agent service: acting for overseas marketing authorisation holders, a step that Slovak law requires them to take.

Who it works with

Marketing authorisation holders for human medicines, including companies with no representation in Slovakia, and manufacturers that need medical device approvals there.

Key facts

• Based in: Bratislava, Slovakia
• Experience: over 25 years in the industry
• Clients: 10+ long-term clients
• Submissions: the firm reports a near-zero rejection rate