CLINIQA Corporation is a proven leader in clinical diagnostics with more than 30 years history manufacturing in-vitro diagnostic products. Our state-of-the-art facility, highly experienced personnel, formulation expertise and regulatory compliance (maintaining the following certifications: cGMP, ISO 13485:2003, 9001:2008, CE Mark, CMDR) help ensure we meet customer requirements.
FDA-compliant, phase-based Design Control processes are utilized for product development of diagnostic calibrators, controls, reagents, calibration verifiers and proficiency testing materials from research and development to product transfer.