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