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Accelerate Your IVD Product Launch Timeline via Professional CDMO R&D Support
Gain customized R&D roadmap, global regulatory guidance(NMPA/CE-IVD/FDA), expert technical consultation and free preliminary project assessment with our senior IVD scientists.
Preparing Your IVD R&D Project | Ensure Smooth Project Kick-off
To shorten your project initiation cycle & improve R&D efficiency, submit your core project parameters (target indication, required technical platform, regulatory target market, expected product specification) via our online form in advance for our pre-project technical review.
Accelerate IVD Innovation with End-to-End CDMO R&D Expertise
In Vitro Diagnostics (IVD) demands robust, reproducible analytical workflows to deliver consistent, clinically compliant diagnostic performance. Our full-service CDMO R&D division covers the complete IVD development lifecycle: from target biomaterial screening, antigen/antibody custom development, assay formula construction, analytical performance optimization, interference & stability validation, up to pre-production process transfer for commercial manufacturing.
Combining GMP-aligned laboratory infrastructure, ISO13485 compliant quality management system and cross-disciplinary IVD scientist team, we streamline your R&D cycle, cut upfront lab investment and minimize technical & regulatory risks across all mainstream IVD technical platforms:
Immunodiagnostic Platforms: CLIA Chemiluminescence, ELISA Enzyme Immunoassay, Fluorescence Immunoassay(FIA), Latex Turbidimetry, Lateral Flow POCT Rapid Test
Molecular Diagnostic Platforms: Real-Time qPCR, Isothermal Amplification, Multiplex Nucleic Acid Detection, Extraction Kit Formulation, Companion Diagnostic Assay Development
Specialized Custom Projects: Calibrator & Quality Control Material R&D, Matrix-based Reference Panel Preparation, In-house Substrate & Biochemical Reagent Custom Synthesis
Our experienced R&D scientists conduct formulation screening, precision performance testing and accelerated stability validation under ISO13485 controlled cleanroom laboratory environments.
Immunodiagnostic Platforms: CLIA Chemiluminescence, ELISA Enzyme Immunoassay, Fluorescence Immunoassay(FIA), Latex Turbidimetry, Lateral Flow POCT Rapid Test
Molecular Diagnostic Platforms: Real-Time qPCR, Isothermal Amplification, Multiplex Nucleic Acid Detection, Extraction Kit Formulation, Companion Diagnostic Assay Development
Specialized Custom Projects: Calibrator & Quality Control Material R&D, Matrix-based Reference Panel Preparation, In-house Substrate & Biochemical Reagent Custom Synthesis
Our experienced R&D scientists conduct formulation screening, precision performance testing and accelerated stability validation under ISO13485 controlled cleanroom laboratory environments.
What We Do?
An expanded panel of essential, conditionally essential amino acids, and non-essential amino acids provides clinical utility and supports the development of personalized treatments. A formula for a customized amino-acid blend is provided with each report, offering suggested replacement amounts based on test results.
Core R&D Service Categories
Diagnostic Biomaterial Custom R&D(Antigen, Antibody, Enzyme Raw Material)
POCT Lateral Flow & Fluorescence Immunochromatography Assay Development
CLIA Magnetic Particle Chemiluminescence Reagent Formulation & Optimization
ELISA & Turbidimetric Immunoassay Custom Development & Method Validation
Nucleic Acid PCR & Isothermal Amplification Diagnostic Kit R&D
Custom Buffer, Blocking Solution & Lyoprotectant Formulation
Regulatory & Technical Support
ISO13485 QMS System Establishment & Gap Remediation
NMPA Class I/II/III IVD Registration Technical Documentation Compilation
EU CE-IVD/UKCA/FDA 510(k) Global Regulatory Dossier Preparation
Pre-clinical Performance Verification & Clinical Trial Document Guidance
Calibrator/QC Reference Material Characterization & Value Assignment
Lab-to-GMP Production Process Transfer & Scale-up Consultancy
IVD R&D FAQ | Common Questions About Our CDMO Service
We sort frequently asked technical & commercial questions from global IVD clients to clarify core cooperation rules of our CDMO R&D program.
Our technical manager will tailor customized service scope after reviewing your product positioning, target regulatory market and development budget, including split-mode R&D cooperation (partial outsourced) and full turn-key CDMO development.
Flexible cooperation modes available: single-project ad-hoc R&D contract, frame agreement for multi-product pipeline development, no mandatory long-term exclusive cooperation constraints.
Stage-based milestone payment aligned with R&D deliverables; optional co-development royalty-sharing scheme for early-stage startup biotech partners, we support flexible commercial cooperation for companion diagnostic projects with pharmaceutical companies.
Flexible Cooperation Modes for IVD CDMO R&D Projects
Our tailored cooperation frameworks accommodate startup biotech, mid-size diagnostic enterprises and pharma CD projects with diversified resource allocation demands.
Full Turn-key ODM
Full-cycle R&D from project initiation to formal registered formula delivery
Partial Outsourcing
Targeted service covering raw material production or assay performance fine-tuning
Reference Material Customization
Custom fabrication and full property characterization of diagnostic reference materials
Process Transfer Service
Pilot validation and GMP-compliant production scaling of mature assay formulas
Regulatory Documentation Service
Independent standalone drafting of all IVD regulatory application documents
Royalty-sharing Co-development
Joint R&D with revenue split for early-phase diagnostic product pipelines
Empower Global IVD Enterprises via Reliable CDMO R&D Infrastructure
Professional Controlled Laboratory & Quality-centric IVD Development Ecosystem
Over 95% of global clinical diagnostic decisions rely on accurate IVD reagent performance; we position ourselves as your trusted full-cycle CDMO R&D partner to de-risk your diagnostic product development and global market access.
How to Kick Off Your IVD CDMO R&D Project | Four-step Standard Cooperation Process
Standardized Project Onboarding Ensures Efficient & Traceable R&D Execution
We follow standardized SOP to manage every outsourced IVD R&D project for full transparency of development progress.
Strict ISO13485 Quality Control
Full-cycle Project Progress Tracking
On-time Milestone Delivery Assurance
Customized Technical After-service
Your focus is on IVD product commercialization and we’re here to support your whole R&D journey.
Quick Contact
If you have any questions or need help, feel free to contact with our team.
2F, Science & Technology Incubation Building, Chongqing Banan International Biocity,China