savyondiagnostics 产品代理
savyondiagnostics 产品代理
Savyon Diagnostics 被称之为最高水准之研究、研发与制造商。该公司已荣获 ISO 13485认证而且所有产品皆有 CE认证。在美国贩售之产品也已取得 FDA核可。在加拿大， Savyon 也有 CMDCAS， ISO 13485 (2003) 等认证。特定的产品也有 SFDA认证，可于中国大陆贩售。
高品质之制造为 Savyon Diagnostics的强项，所以该公司也为许多不同规格之公司代工。
Reagents & Chemicals
Savyon Diagnostics offers a range of Over-The-Counter diagnostic kits allowing easy-to-use diagnostics in the comfort of one’s home. An accompanying mobile application allows the patient to share his/her results with their personal physician to provide a holistic at home diagnostics solution. Savyon Diagnostics is also developing solutions for labs providing personalized medical care.
Savyon Diagnostics tests are based upon various immunological and molecular biology techniques (ELISA, Lateral Flow, RT-PCR, MIF, IPA and others). The company possesses the unique “know how” of producing quality core biologicals including: antigens, antibodies and nucleic acid-based probes, while using cutting edge technologies to manufacture the products to the high standards that laboratories and research institutions have come to depend upon.
Savyon Diagnostics is accredited with the highest international quality standards of research, development and manufacture, including ISO 13485-2016. The company’s products are all CE IVD certified and those products sold in the USA, China, Mexico, Brazil and Australia are FDA, CFDA, ANVISA, COFERIS and TGA approved, respectively.
Savyon Diagnostics products are developed by our experienced and skilled R&D team who maintain close relationships with international key opinion leaders and academic institutions. Building upon our excellence in research, development and manufacturing, Savyon Diagnostics also offers contract development and manufacturing services. Numerous successful development and manufacturing projects have been completed or are currently ongoing with companies varying from startups to medium and large multinational enterprises.
Savyon Diagnostics has recently established an Analytical Services unit. The unit complies with GMP guidelines as required by the International Conference on Harmonization (ICH) for active pharmaceutical ingredients. Glycoanalysis services include:
N-link glycan analysis by HPLC
O-link glycan analysis by HPLC
Profiling and quantitative analysis of sialic acid (NeuAc and NeuGc)
Quantitative monosaccharaides analysis
The Analytical Unit complements the wide range of services offered by Savyon to the pharma, biotech, IVD and life sciences community and recently offering as well its unique expertise for companies specializing in cannabis-derived therapeutics.
Savyon Diagnostics为 “Gamida Diagnostics Division”
