Specialists in Fermentation based APIs Contract service provider for R & D, assay development, stability studies, process scale-up and optimization as well as CGMP manufacturing up to commercial scale.   Quality Control and Methods Development     Quality Assurance     Regulatory Affairs
	Quality Control and Methods Development   Quality Control and Methods Development includes an analytical lab, a microbiology lab and a methods development lab. Our QC team provides an entire gamut of analytical / microbiological services to production including: analytical / microbiological tests for raw materials, in-process controls and intermediates and tests on final products according to in-house / pharmacopeias (EP/USP) methods, plus stability studies as per ICH guidelines. The methods development lab refines and validates all the methods used for quality testing. In-house QC Instrumentation Includes: Waters HPLCs with UV (PDA) / RI detectors Agilent GCs: Headspace and direct injection with TCD, FID detectors Varian GC: Headspace and direct injection with FID detector Dionex Ion Chromatograph Varian UV-VIS Spectrophotometer BIORAD FTIR Spectrometer Mettler Toledo Karl Fischer Titrators Optical Activity Automatic Polarimeter IONICS Total Organic Carbon Analyzer Micro balance / analytical balances Clickable Thumbnails
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