Our Services
We offer end-to-end solutions from initial R&D to large-scale commercialization. We combine advanced bioinformatics with deep laboratory expertise to help you develop, validate, and manufacture high-performance IVD products. Whether you are navigating complex regulatory pathways or seeking scalable OEM manufacturing, our team of scientists and experts is dedicated to transforming your diagnostic vision into market-ready reality.
Contract Research
Expertise in IVD Research & Development
NeoDx offers comprehensive contract research services tailored for the IVD industry. We bridge the gap between initial concept and commercial reality by providing deep technical expertise in product development and molecular research.
Benefits You'll Get:
End-to-end support from feasibility to proof-of-concept
Expertise in MultiPlex and SinglePlex molecular design
Strategic R&D consulting for complex diagnostic needs
Assay Development
Customised Assay Development Services
We specialize in developing high-performance molecular assays with a focus on sensitivity and specificity. Our team optimizes every parameter, including primer/probe design, master mix formulation, and limit of detection (LoD).
Benefits You'll Get:
Custom RT-qPCR and isothermal assay optimization
Validation across diverse clinical sample matrices
Quick-turnaround development for an immediate start
Quality & Regulatory
Regulatory Compliance & Quality Assurance
Navigating the intricacies of the global regulatory scenario is now easy with NeoDx. Our offerings include technical documentation and quality management systems that meet CDSCO, US-FDA, and EU-IVDR regulations for medical devices.
Benefits You'll Get:
ISO 13485:2016 compliant documentation and support
Comprehensive performance evaluation and technical files
Expert guidance on Class A through D regulatory pathways
OEM Manufacturing
Scalable OEM & Contract Manufacturing
Scale your production without the cost. We have a state-of-the-art facility that provides white-label manufacturing services, where your diagnostic products will be manufactured according to the highest quality standards.
Benefits You'll Get:
High-throughput automated production and kit assembly
Rigorous quality control and batch-to-batch consistency
Seamless technology transfer from R&D to large-scale output
