Our proven and well-tested Standard Operating Procedures (based on established and approved international guidelines and the product specific adjustments) enable a highly elaborated collection of assay performance data. The extensive evaluation of performance characteristics of our products thus includes the assessment of analytical as well as clinical performance with regards to sensitivity, specificity, stability, robustness, reproducibility and more.
The data are collected, statistically evaluated and documented in a detailed product specific technical report, which is an ideal information summary for registrations, product information and customer service.
We provide professional expertise for the subsequent US Food and Drugs Administration (FDA) and CE-marked certifications for a successful product launch of Companion Diagnostic tests.
Preferably knowledge and proven track record in regulatory activities including those relating to the FDA, Europe, Canadian Medical Device Regulations and China.