Cisema is a CRO (clinical research organization) and turnkey regulatory affairs solutions provider for the China and Hong Kong market, with a large on-the-ground contingent of local Chinese staff and satellite sales offices around the world with someone that speaks your language. Our special focus is China regulatory affairs for product registration. In China, certain product groups require compulsory registration (e.g. NMPA, CCC, CEL, CML) before they can be imported, traded and used. We are a one-stop service provider supporting your company register its product for sale in China, conduct clinical trials (we’re a CRO) and monitor post-registration compliance.

Cisema is the largest consultant company in the EU for China regulatory affairs. We are fast growing with an increasing number of customers in US, Japan, Korea and Israel.

Our expertise includes the NMPA (formerly known as CFDA) registration for medical devices, IVDs, pharmaceuticals (DMF), cosmetics, health food and other life sciences products. We have nearly 100 full-time employees and 20 years' experience supporting companies certify their products for sale in the Chinese market.