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Quality Testing involves developing a Quality Management System of your drug substance and drug product.

Kamat Pharmatech can demonstrate quality of effective systems to be used in pre-clinical and clinic studies as well as manufacturing by verifying such protocols written. Kamat Pharmatech provides clients with studies related to ICH 10 "Pharmaceutical Quality Systems" which can provide important data when filing.

Developing a QMS for you product is very important when it comes to commercialization, thus studying and preparing this system can start during initial stages. Even though during initial stages the product is still developing, understanding such Quality Aspects early can help tremendously when it comes to final stages.

Relevant Instruments

DensitometerMETTLER TOLEDODensito 30PX
Differential Scanning CalorimeterPerkinElmerDSC4000
Freeze Drying MicroscopeLinkamOlympus BX51
HPLC-CAD SystemPeak Scientific Instruments Ltd.Corona Nitrogen 1010
HPLC-RIDSHIMADZURID-20A
HPLC-UV SystemSHIMADZULC-2010AHT
HPLC-UV SystemSHIMADZULC-2010AHT
Karl-Fischer CoulometerMetrohm831 KF Coulometer
OsmometerADVANCED INSTRUMENTS INC.Model 3320
Oxygen MeterPreSensMicrox 4
Particle Size Distribution AnalyzerShimadzuSALD-2300
PolarimeterAzzota CorporationAP-45
RheometerTA InstrumentsDiscovery HR-2
Texture AnalyzerStable Micro SystemsTA.XT plus Texture Analyzer
Type IV Dissolution ApparatusSOTAXCE7 smart
UV-Vis SpectrophotometerAzzota CorporationSM1000 UV-Vis Spectrophotometer
ViscometerRHEOSENSE, INC.uVISC
Zeta Potential MeterMicrotracZETA-check PMX 500
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