Atlas-Link Biotech (Beijing)
In recent years, Laboratory-Developed Tests have gained major attention over questions concerning FDA oversight, medical and diagnostic validity, and fulfillment of certain medical device systems. Though having analogous usage as an FDA-accepted IVD test, a Laboratory-Developed Test is created and authenticated for use by a single clinical laboratory.
Laboratory-Developed Tests continue to be imperative in the development of personalized medicine, which has emphasized the significance of precision, clinical and diagnostic validity. To this end, dictatorial authorities are increasingly demanding such studies under the more severe Clinical Laboratory Improvement Amendments regulations. At Atlas-Link Biotech, we design and carry out diagnostic as well as clinical legalizations for custom assays through our well-established clinical laboratory.
During the developing process, opportunities may be lost to advance personalized IVD products because of complexities. As the leading foreign trade company in Beijing, China, Atlas-Link Biotech is dedicated to assisting biopharmaceutical companies to deliver regulatory-standard companion diagnostics, which can influence the way the IVD products will be designed in the future.
Atlas-Link Biotech has been offering a comprehensive range of in-vitro diagnostic products since 2004. We offer a comprehensive customer support service within a single outsourcing process to biotechhnology, pharmaceutical, or diagnostic companies. As a matchless services body, we tendered an integrated development process for discrete or multiple stage projects and customized diagnostic projects to increase the needs of our customers.
As a pioneer in the industry, we can participate in every stage in the process, from assay perception and biomarker detection, through clinical corroboration and regulatory sanction, to final kit production, to support the project needs of our customers. The team of Atlas-Link Biotech is highly accomplished in all phases of a project, related to regulated, as well as non-regulated environments not only in China but also throughout the world by supporting analytic development affiliations worldwide.
As our professional foreign trade company has a strong global presence for more than 15 years in this industry, we have wide development capabilities. As we offer a varied array of technologies and platforms, we are capable of supporting the entire molecular and non-molecular development and testing requirements.
When we manufactured our products with the platform of colloidal gold immunochromatography, we also kept ourselves updating on other latest technologies and instruments. Our Nova Test Kits and Senso Test Kits are the most sought-after tools amid many healthcare professionals around the world. This is the reason that why they are flawlessly designed to detect amount of types of viruses, including the COVID-19.
Founded in 2004, Atlas-Link Biotech has become the deeply trusted and reputed business in the world. Our business model has been professionally designed to integrate and handle the majority types of in-vitro diagnostic growth expertise as well as services within our business. This assessment was driven by the increasing demands of personalized remedy and necessity for a simpler path for aligned growth and regulatory approval of a remedial and its companion diagnostic. The business model of Atlas-Link Biotech decreases an over-onerous process by the high caliber of its managerial structure without opposing interests and allows for deliberation of budding molecular technologies in the growth process.
Genomic or customized therapeutics have turned out to be the core of IVD industry, creating the need for corresponding companion diagnostics. As a full-service diagnostics business in China, Atlas-Link Biotech is committed to offering a start-end partnership for the joint growth of companion diagnostics.
At Atlas-Link Biotech, we design, handle, and organize all aspects of the diagnostics growth process, concept through standard approval, by providing independent and impartial guidance, which is based on the objectives and goals of our customers. As a solitary outsourcing associate, we are capable of offering a flexible process, which is malleable to changing needs, schedules, and priorities.
Schedule a discussion with the R&D team of Atlas-Link Biotech to solve your precise issues.