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GMP analytics and quality control

Quality control is an integral part of the drug production process. Selvita specializes in the final stage of quality control of pharmaceutical products (small and large molecules) – routine analyzes of batches for release (release testing).

This type of testing is based on the approved specification of the drug product. Selvita does not have a GMP production line but holds GMP certificate and manufacturing license which allow to perform release testing by our GxP laboratories. Selvita also holds the import license which is required for release testing of batches that were produced outside the EU.

Selvita’s portfolio of methods for release testing is very extensive. We offer the following physico-chemical methods: HPLC, UHPLC, RP-HPLC, SEC, IEX, IF, CE, GC, IEF, LC/MS, SDS-PAGE, AAS, ICP-OES, ICP-MS, disintegration time, dissolution, and also biological methods: microbiology testing: sterility, purity, endotoxins, cell culture based bioassays: proliferation assays based on different read-outs, ADCC, CDC, apoptosis assays, reporter gene assays, potency assays. We are proud to be the EU release testing laboratory for the world’s largest pharmaceutical manufacturers.

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