We provide dedicated contract manufacturing services for lateral flow assays, designed to help diagnostic innovators scale with precision and speed. Our ISO 13485 facility in the heart of Hyderabad, India, is optimized for companies that require a “build-to-print” partner who can bridge the gap between pilot-scale development and high-volume commercialization without the burden of excessive minimums.
- Low-to-Mid Volume Support: Solutions for validation studies, clinical trials, and niche diagnostic products.
- Rapid Commercial Scaling: Ensuring a seamless transition from low to high-volume supply.
- Cost-Efficient Entry: Significantly lower MOQs than traditional facilities.
We utilize a semi-automated production model. This approach offers the ideal balance of machine-driven consistency and expert manual oversight:
- High-Precision Assembly: Automated lamination, reagent dispensing, and strip cutting ensure technical uniformity across every batch.
- Process Agility: Semi-automation allows us to pivot between different test formats, housing types, and custom kitting requirements with minimal downtime.
- Enhanced Quality Control: Critical assembly stages are monitored by trained technicians.
- Reagent Dispensing: Controlled application of capture and detection reagents.
- Lamination: High-precision multi-layer assembly of membranes and pads.
- Precision Cutting: Accurate strip cutting to specified tolerances.
- Environmental Control: Humidity and temperature-controlled environments to protect sensitive nitrocellulose components.
- Packaging & Kitting: Custom desiccant insertion, pouch sealing, and final kit assembly.
Our facility operates under a rigorous Quality Management System (QMS) that meets international medical device standards.
- Dedicated CMO Services: We focus purely on manufacturing. We do not offer assay development or regulatory services, ensuring your intellectual property remains secure and our focus remains 100% on production excellence.
- IP Protection: We operate as a “neutral” manufacturing partner, maintaining strict confidentiality over your proprietary chemistry and designs.
We provide a clear path from technical transfer to routine supply
