Analytical laboratory

Analytical laboratory

BIA Separations CRO analytical laboratory is a contract research laboratory providing high quality services in the field of chromatography and dissolution testing.

GMP: In 2011, BIA Separations CRO laboratory was certified by the Agency for Medicinal Products and Medical Devices of the Republic Slovenia as a holder of the Certificate of GMP compliance of a manufacturer, Quality control testing.

FDA: In 2002, 2009 and 2014, BIA Separations CRO was inspected and certified by the US Food and Drug Administration (FDA) to perform control testing of drugs.

We can provide you with the following services:

    • Development of HPLC and GC analytical procedures
    • Development of analytical procedures for cleaning validation process
    • Validation/verification of analytical procedures (HPLC, GC, dissolution) for assay, related substances, degradation products, residual solvents, cleaning validations (swabs and eluates)
    • Analytical testing of assay, related substances, dissolution (apparatus 1 and 2) in stability studies
    • Quality control testing of final products
    • Quality control of cleaning validation testing
    • Analytical testing regarding process validation
    • Development projects regarding life cycles of chromatographic material
    • Development projects regarding leachables determination of chromatographic materials
    • We are proud to state that we are a service provider for several small, medium and big pharmaceutical companies all over Europe.