Syntezza Bioscience

Syntezza Contract Services can design, manage, and coordinate all aspects of the development of a diagnostic product. Our organization includes an experienced team and regulatory compliant facilities for assay & process development, cGMP manufacturing, platform evaluation, software validation, custom diagnostic software, analytical performance validation, complete regulatory documentation, and regulatory application. We offer a full line of services to carry your development from concept, through design transfer and kits for clinical studies & commercial sales. All services include preparation of relevant documentation needed for regulatory submission and OEM production of approved products (CE, FDA 510(k) or FDA PMA).