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About Cisema

Founded by a former Siemens engineer in 2002, Cisema is the Regulatory Affairs, Quality & Compliance Consultancy of choice for China and now South-East Asian markets. We specialize in Medical Devices & IVDs, Pharmaceuticals (including API, excipients and packaging DMF), Cosmetics, Cosmetics ingredients, Health Foods, and Industrial & Consumer Goods for manufacturers seeking support in China and the wider Asia Pacific with a focus on South-East Asian markets of Singapore, Vietnam, Malaysia, Thailand, Indonesia and Philippines. Cisema assists companies obtain product registration, achieve local in-country testing, draft and submit application dossiers, act as local agents so you don't have to set up a local country offices and continue to comply with post-market surveillance requirements. We can also conduct in-country or overseas audits according to various standards. Are you a MedTech manufacturer? A Pharma or Biotech or pharmaceutical API, excipient or packaging manufacturer? Cosmetics brand? Cosmetics ingredients manufacturer? Special equipment (pressure vessel) manufacturer? Component or parts supplier or have other certification or compliance needs in China and wider Asia Pacific? With nearly 100 dedicated employees in 12+ locations worldwide focused on China and South-East Asian regulatory and quality compliance, clinical services, safety certifications and local agent services, we enable global trade to support user choice and safety. We will help you obtain marketing approvals, and continue to comply with post-market obligations. We also act as local agent or authorised representative so you don't have to set up a local office in China, Hong Kong, Taiwan, and the key South-East Asian markets of Singapore, Vietnam, Malaysia, Thailand, Indonesia and Philippines. Visit cisema.com for more.

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