Services
Development and manufacturing, under one quality system
Every engagement is operated under ISO 13485 design control and WHO-GMP manufacturing, whether we develop an assay to your specification, transfer your validated design, or supply catalog products under your brand.
Contract development (CDMO)
You define the analyte, sample matrix and intended use. We take the assay from antibody sourcing and feasibility through design, optimization and verification to design transfer into GMP manufacture.
Formats: LFIA · ELISA · CLIA · Deliverable as registered kit or design-transfer package
Contract manufacturing (CMO)
A validated design is transferred into our Hyderabad production lines: incoming QC to your specification, in-process controls, lot release with full documentation, and stability programs to support your registrations.
Lot documentation: batch records · CoA per lot · stability data on request
OEM and private label
Catalog assays packaged and labeled to your specification. Artwork adaptation, IFU localization and regulatory documentation support are included. Minimum order quantities depend on format.
Catalog: 179 assays across LFIA, ELISA and CLIA
Development process
Five stages with defined deliverables. Each stage gate requires your approval before work proceeds.
- WEEKS 1–4
Feasibility
Antibody sourcing, matrix screening and proof-of-principle prototype.
- WEEKS 5–10
Development
Assay optimization for sensitivity, specificity and design stability.
- WEEKS 11–16
Verification
Pilot lots, precision and interference studies, and shelf-life study initiation.
- WEEKS 17–20
Design transfer
Device master record, line qualification and process validation at scale.
- ONGOING
Manufacture
Routine GMP production, lot release and post-market support.
Submit a project brief
Analyte, format and expected volumes are sufficient for an initial assessment.