Research & development
North Carolina, USA
Assay design, antibody characterization, feasibility, and verification. Development runs under ISO 13485 design control from the first experiment.
About
An IVD manufacturer operating under pharmaceutical quality systems
Nova Dx is a subsidiary of Promea Therapeutics, established to apply the group's pharmaceutical quality systems to in-vitro diagnostics. We develop and manufacture LFIA, ELISA and CLIA products, and operate as a CDMO, contract manufacturer and OEM supplier.
Two sites, one quality system
Manufacturing
Hyderabad, India
WHO-GMP production of rapid tests, microplate assays and CLIA reagents, with lot release and stability testing on site.
Quality & certifications
Both sites operate under a single quality management system. Design history files, device master records and lot documentation follow the same procedures for catalog products and client products alike.
- ISO 13485
- Medical devices — quality management
- ISO 9001
- Quality management systems
- CE-IVD
- European conformity for IVDs
- WHO-GMP
- Good manufacturing practice
Part of Promea Therapeutics
Manufacturing capacity, raw-material sourcing and regulatory infrastructure are shared across the group.