Cisema GmbH

Industry

Advisory / Consulting

Languages

English, French, German, Italian, Spanish, Chinese , Cantonese, Korean, Japanese

Country and Region

Germany

Website

https://www.cisema.com/

About Cisema GmbH

Cisema is a leading provider of regulatory affairs, quality compliance, clinical research, and product testing & safety certification for China.

We enable compliance across various industry sectors including medical devices, in-vitro diagnostics (IVD), pharmaceuticals, veterinary drugs, pet food, cosmetics, health supplements, automotive, and toy manufacturers worldwide.

Whether providing regulatory advice on market entry strategies, acting as your local authorized representative, registering your products, achieving customs clearance, adapting your QMS, or preparing you for factory inspections, Cisema offers comprehensive regulatory compliance services.

Additionally, we assist pharmaceutical companies with regulatory submissions, including Drug Master File (DMF) support, alongside services like China Compulsory Certification (CCC), Manufacturing License (SELO) for pressure-bearing parts, and Energy Efficiency Labelling (CEL).

Founded in 2002, we have expanded to 12 offices globally over the last 20+ years, with service delivery operations in China and sales representative offices worldwide. Our expertise covers product approvals of all classes, therapeutic areas, types and specifications, benefitting startups, SMEs, or MNCs alike.