Full instrumentation and bioprocessing equipment validation for regulated pharmaceutical and biomanufacturing environments. This includes mass spectrometers, bioreactors, single-use bioreactors, chromatography systems (HPLC, FPLC, UF/DF), centrifuges, filtration skids, and other critical process equipment. Services cover complete risk-based validation strategies (GAMP 5, ICH Q9), development and execution of IQ/OQ/PQ protocols, performance qualification, deviation resolution, and comprehensive audit-ready documentation packages that meet FDA, EMA, and cGMP requirements. $225-$275/hour plus travel. Fixed-Project fees are available.
Full instrumentation and bioprocessing equipment validation for regulated pharmaceutical and biomanufacturing environments. This includes mass spectrometers, bioreactors, single-use bioreactors, chromatography systems (HPLC, FPLC, UF/DF), centrifuges, filtration skids, and other critical process equipment. Services cover complete risk-based validation strategies (GAMP 5, ICH Q9), development and execution of IQ/OQ/PQ protocols, performance qualification, deviation resolution, and comprehensive audit-ready documentation packages that meet FDA, EMA, and cGMP requirements. $225-$275/hour plus travel. Fixed-Project fees are available.