Global Coverage
Our international registration team functions globally, providing assistance to medical device and IVD manufacturers for achieving market access. Collaborating with our local experts, we formulate your comprehensive regulatory strategy on a global scale and devise an efficient roadmap to ensure compliance with local requirements. We facilitate the registration of your products and ensure the continuous compliance in each target markets.
United States
Expert guidance and support to ensure your products meet compliance standards and obtain FDA clearance.
China
Comprehensive range of NMAP regulatory compliance & clinical research support in China.
Europe
Our MDR/IVDR experts will help to navigate the complex regulatory landscape and ensure compliance in EU market.
Asia
Comprehensive range of NMAP regulatory compliance & clinical research support in China.
Latin America
Submission preparation and in-country representation for this competitive emerging market.
Russia
Unlock your product’s potential in the Russian market, ensuring compliance with Russia’s regulatory standards