Established in 2015, Guangzhou BDS Biotech features two platforms: a research institute and an industrial center. The company's business purpose and strategic direction are "With standards and led by industrial transformation, build the platform for biological standards".
Research and development of biological reference materials and quality controls: Conduct research and development of biological reference materials and third-party quality controls in clinical molecular diagnostics, immunodiagnostics, clinical biochemical testing, animal diseases, and other fields.
Industrial services: Providing one-stop product registration guidance for medical devices.
We possess a series of quality control industry platforms covering nucleic acid, immunology, biochemistry, sequencing, mass spectrometry, flow cytometry, pathology, and animal diseases. We can provide various forms of third-party quality control materials, including Class II national certified reference materials, verification panels, external quality assessment samples, and internal quality controls.
A third-party CDMO platform offering medical device sample development and product manufacturing.
The company has developed over 140 certified national secondary standard reference materials and more than 1,000 third-party quality control materials. It has assisted medical device companies in completing over 900 product registrations.
Among them, the quality of a series of reference materials for EBV DNA, HCMV DNA, HPV16 DNA, HPV18 DNA, ADV7 DNA, H1N1 RNA, H3N2 RNA, IVB RNA, animal diseases such as porcine reproductive and respiratory syndrome virus (PRRSV) European strain (PRRSV LV)/American variant strain (PRRSV JXA1)/American classical strain (PRRSV VR2332), porcine circovirus type 1 (PCV1)/type 2 (PCV2), monkeypox virus F3L gene pseudovirus nucleic acid, and Brucella ovis genomic strains has reached the international leading level, with many being pioneering in China or internationally.
Jiangsu BDS Biotech Co., Ltc, founded in 2018, is a leading third-party service provider in China's biomedical device industry. The team has secured over 900 regulatory certificates (including medical device registrations, new drug certificates, and other certifications) for subsidiaries and affiliated companies of the Da'an Group, as well as for other industry partners. The company holds nearly 400 intellectual property certificates and has had 158 products approved as Guangdong High-Tech Products over the past three years. It has successfully guided manufacturers in applying for over 10 innovative green channel initiatives, covering areas such as prenatal diagnosis, tumor marker gene detection, microfluidic chip technology, and implantable biomaterials.
With standards and led by industrial transformation, build the platform for biological standards
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