Regulatory studies

Being a versatile contract research organization, for over a decade Selvita has been providing also world-class pharma services in the field of drug testing and bioanalytical analyses. We offer services at every stage of the drug development process, from development and validation of methods, stability studies, to routine quality control testing.

The quality of our services has been repeatedly confirmed during the GMP and GLP inspections. Obtained GMP and GLP certificates additionally prove that services provided by Selvita are performed in accordance with the highest standards of the pharmaceutical industry, and cover all services offered by our laboratories.

We are located in Krakow having a total area of 4,000 m² (laboratory and office spaces) of which approximately 800 m² are GxP-certified laboratory spaces. The GxP spaces are divided between two departments: cell and molecular biology and analytical laboratories. Both departments provide analytical services to the pharmaceutical industry, especially in the quality control area. In addition to being equipped with state-of-the-art analytical devices, the cell and molecular biology laboratory works under the biosafety level 2 regime. All laboratory activities are conducted under Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) and according to valid ICH guidelines.
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