About our Business
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Our Services
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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.
Copyright ® 2005 NCS Pharmaceuticals. All Rights Reserved.