Validation & Registration
Validation and documentation
Our proven and well tested Standard Operating Procedures-based on the established and approved international guidelines and the meticulous product specific adjustments thereof 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.
R-Biopharm´s validation and documentation approach
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 FDA and CE-marked kit registration for a successful product launch of drug and CDx test.
Preferably knowledge and proven track record in regulatory activities including those relating to the US Food and Drugs Administration (FDA), Europe, Canadian Medical Device Regulations and China.