Contract
Research
NeoDx is dedicated to shaping the human healthcare experience by creating unique products that give healthcare professionals an edge in their ability to diagnose and treat conditions that enhance their patient’s health outcomes.
We offer our expertise by supporting individuals and companies that want to transform their ideas into a product.
Areas of IVD
NeoDx provides support and guidance to companies in developing
-
Point of Care tests/Devices (POCT)
-
Lateral Flow Assay Devices/Tests
-
Clinical / Molecular Diagnostics
-
RT-PCR-Based Diagnostic Kits for Infectious Diseases
-
RT-PCR-Based Diagnostic Kits for Oncology
-
Genetic Disorders Diagnostics
Expertise in Every Class of Product Development
Medical Devices in India are classified as either Class A, B, C, or D; with Class A and B posing the least risk and Class C or D posing the highest risk to patients.
At NeoDx, we understand the Classification Process and the strategy required from defining the product to taking it to the market.
We will guide you through the validation process to ensure that your products reach the viable market.
Our Expertise in IVD Contract Research extends to
-
Formulation, Concept, and Feasibility
-
Design and Development – Verification & Validation
-
Final Validation
-
Project Management
-
Data Management
-
Quality Assurance
-
Regulatory Support
-
Trained and experienced personnel in R&D, Production, and RA/QA.