CRO, ANALYTICAL SERVICES: NCS Pharmaceuticals' contract analytical testing laboratory is offering cGMP, and GLP services to the pharmaceuticals, medical devices, food, dietary supplement, cosmetics, chemical, environmental, and allied industries. Our clients in the pharmaceuticals industry range from suppliers of Bulk Drug Substances to manufacturers of brand name and/or generic Finished Drug Products. Our test procedures are based either on the FDA, ICH ISO guidelines, USP/NF, BP, EP, JP monographs, or on the clients' SOPs. We specialize in the chemical analysis, dissolusion testing, and stability testing of both non-controlled and controlled drug substances in schedules II thru V. Our testing capabilities include: HPLC, GC/LC, Atomic Absorption Spectroscopy, and Mass spectrometry.    SERVICES OFFERED: Development of analytical methods (HPLC and GC) for the     assay and purity of active/inactive pharmaceutical ingredients in drug products/drug substances. Validation of HPLC and GC methods (assay and purity) for drug substances/drug products. Transfer of validated analytical methods to different laboratories. Stability studies on drug substances/drug products. Identification of unknown impurities in drug substances/drug products by LC/MS and or GC/MS. Characterization of peptides, proteins and industrial polymers using Matrix Assisted Laser Desorption Time Of Flight Instrument. Elemental analysis using Atomic Absorption Spectroscopy. Identification and Quantitation of both aqueous and volatile inorganic and organic chemical components from combination products such as biological drug in disposable syringes Filing of IND, DMF, NDA and ANDA submissions with FDA ENGINEERING AND VALIDATION SERVICES: NCS Pharmaceuticals is a full-fledged organization for Commissioning, Engineering Design, Qualification / Validation and Regulatory Affairs of the cGMP Biopharmaceuticals, Medical Devices, Pharmaceuticals and Consumer Product industries. NCS Pharmaceuticals employees have been greatly involved with the commissioning and validation of equipment, systems and entire facilities since the inception of validation by the pharmaceutical industry. We utilize our cGMP compliance and validation methodology which is developed by NCS Pharmaceuticals to optimize the execution of the commissioning and validation phases of a project. This methodology allows us to generate a cost effective validation program minimizes overall project execution time. NCS Pharmaceuticals Analytical and Bio-analytical support started upon the request of clients who needed the help of seasoned analysts to work with their Quality Assurance Unit to validate their instrumentation, software, and to provide various other value-added services to assist them to create or maintain a strict compliant infrastructure.  We are not only quality consultants engineering company helping pharmaceuticals, health care and consumer products industries; we are also having highly experienced seasoned analytical / bio-analytical scientists.  Our combined expertise includes commissioning, manufacturing process optimization and validation, formal GLP and GMP method validation and sample analysis, SOP writing, review, and revision, e-data compliant archival and storage in accordance with FDA 21CFR part 11 compliance , and indisputable issue resolution.