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.
Company Details
- Employees
- 28
- Founded
- -
- Address
- 5-11 Thomson Rd, Wan Chai, 7a,germany
- Industry
- Business Consulting And Services
- NAICS
-
Management, Scientific, and Technical Consulting ServicesManagement Consulting ServicesOther Scientific and Technical Consulting ServicesOther Management Consulting Services
- Website
- http://www.cisema.com/en
- Keywords
- Medical Devices, Regulatory Affairs, CCC, CEL, HAF 604, Certification, Quality Control, SELO, CRO, NMPA, China customs clearance, China product testing, IVDs, China Drug Master File, Drugs, Pharmaceuticals, Life Sciences, CML, CFDA (China FDA), cosmetics, cosmetic ingredients, health food, Drug Master File (DMF) for API, excipients and packaging, Market access, Clinical Development, Quality, Singapore HSA, Hong Kong Health Authority, Taiwan FDA, Malaysia MDA, Vietnam MoH, Indonesia MOH, Philippines FDA, Thailand MoPH.
- HQ
- Wan Chai, Hong Kong
Cisema Questions
Cisema's website is http://www.cisema.com/en
Cisema's LinkedIn profile is https://www.linkedin.com/company/cisema
Cisema has
28 employees.
View email and phone details for 28
employees at Cisema.
Cisema's industry is
Business Consulting and Services
Cisema's top competitors are
Genentech,
Whx Bangkok | Whx Kuala Lumpur,
Roche,
Andaman Medical,
Hong Kong Exchanges And Clearing Limited (Hkex),
Pharmalex,
Innovation Norway,
Vita Green,
Parexel,
Asia Actual.
Cisema's categories are Business Consulting and Services
Cisema's founding year is 2002
