CLINIQA Corporation is a proven leader in clinical diagnostics with more than 40 years history manufacturing in-vitro diagnostic products. Our state-of-the-art cGMP facility, highly experienced personnel, formulation expertise and regulatory compliance (maintaining the following certifications: ISO 13485:2016,
EN ISO 13485:2016, CE Mark
MDSAP) help ensure we meet customer requirements.
FDA-compliant, phase-based Design Control processes are utilized for product development of diagnostic assays (reagents, calibrators, controls, calibration verifiers and proficiency testing materials) from research and development to product transfer.