Providing a one-stop service for IVD R&D, registration, manufacturing, after-sales support, and localization of the international supply chain.
Bonded Zone + R&D/Warehousing/Production… Services
Import and Export Supply Chain Services
R&D Laboratory Services
Registration + CRO Services
Biobank Services
Customized Services
IVD International Sample Search System
Ruiya Bioconstruct is building an international sample bank system capable of storing 3 million samples, covering more than 20 specialized testing areas—including biochemistry, immunology, tumor markers, autoimmune diseases, and infectious diseases—while encompassing over 1,200 distinct analytes. The sample bank offers a variety of anticoagulant matrices, such as EDTA, heparin, sodium citrate, citrate-based solutions, and even non-anticoagulated options, along with comprehensive traceability information. Additionally, the system provides access to rare analyte projects, including tests for anti-HIV 2, HIV p24 antigen, Alzheimer’s disease, and other related assays, and can also deliver customized sample-collection services tailored to specific analytes.
CRO Services
Providing standardized laboratory facilities equipped with shared instruments and equipment to meet the experimental and sample needs for product development, formulation optimization, clinical comparisons, and more.
We provide comprehensive experimental support covering the entire lifecycle of non-clinical products, including preclinical studies, kit performance validation services, and full-scale clinical evaluation outsourcing. Our expert team can assist you with everything from setting up experimental facilities and handling ethical submissions to overseeing the entire process—ensuring your product registration journey progresses smoothly and efficiently.
Registration Guidance Service
Before Registration: Strategic Planning—Success Starts at the Starting Line
Led by renowned domestic experts, we provide you with scientific and forward-thinking guidance on registration strategies. Our expert team leverages deep insights into both domestic and international regulations and technical review requirements, offering end-to-end support—from project initiation and document preparation to designing the optimal submission pathway and facilitating seamless communication and coordination. We conduct comprehensive compliance reviews and meticulously plan your regulatory journey, helping you proactively identify and mitigate potential technical and policy risks to ensure the high quality, compliance, and completeness of your registration materials. Additionally, our team can assist in fostering efficient communication with regulatory authorities, accelerating the review process and laying a solid foundation for your product’s successful approval—enabling you to seize market opportunities ahead of the competition.
Registering Now: Tackle It Efficiently, Secure Approval with Ease
Our expert team provides end-to-end support and precise product-assessment assistance, backed by a standardized GMP-compliant production facility that ensures seamless integration into the quality system. During the submission phase, we offer comprehensive, meticulous management and technical support. And when critical steps like clinical supplementation arise, our seasoned experts will personally guide you, crafting tailored, high-efficiency strategies to address review concerns directly—helping you streamline the approval process and significantly reducing the time to market for your product.
Headquarters address: Building 1, Shenfubao Science and Technology Ecological Industrial Park, No. 18 Jinxiu West Road, Pingshan District, Shenzhen
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