You need Java to see this applet.
Copyright ® 2006 NCS Pharmaceuticals. All Rights Reserved.
Press Release:
Smiths Detection and NCS Pharmaceuticals Expand
Support Offerings for S
miths' Clients Globally

COMPETITIVE TECHNOLOGIES FORMS ALLIANCE WITH
NCS PHARMACEUTICALS

NCS Pharmaceuticals Analytical/Bio-analytical Services
Capabilities include:

Method and Protocol Development/Validation/Transfer as per current
FDA/USP/ICH compliances.

Analytical and Bio-analytical stability indicating release method
development for finished product
for small organic molecule based active pharmaceutical ingredients,
validation and
transfer as per cGMP / ICH guidelines.

Pre-clinical IND studies for PK/TOX/ADME studies of investigative
small organic
molecule/small Peptide based drugs.

Impurity Profiles for active drug substance and drug products.

Container aqueous and volatiles Leachables/Extractables organic and
inorganic chemical species.

Analytical R&D support for Proteomics/Biomarker discovery aims to
identify protein markers
for early detection of diseases.

Support for pre-clinical drug discovery and development (screening of
commercial or
client-supplied libraries of small molecules using cell-based assays).

Support ELISA-based diagnostic assays.

Support for Biomarker discovery of different diseases.

NCS Pharmaceuticals instrumentation, equipment, and
analytical methodologies:
Chromatography (TLC, GC, HPLC, GC/MS/MS, LC/MS/MS, IC, GPC,
DSC, Headspace Analyzer,
ICP-MS, MALDI-ESI-QTOF).

Spectroscopy (FTIR, UV/visible, Atomic Absorption, Inductively
Coupled Plasma-Atomic
Emission (ICP-AE, spectrofluorimetry).

Titrimetry, including Karl Fischer reagent and Oven/Coulometry for
water content
Disintegration/Dissolution (including extended release).

Fluorescence 2-dimensional differential in-gel electrophoresis (2D-
DIGE).

Protein/antibody Microarray for biomarker discovery.

ELISA-based assays using Luminex technology.

Screening of library of small molecules for drug discovery and
development using Biomek 2000
or Biomek FX automated workstation (BECKMAN COULTER).






NCS Pharmaceuticals is also a full-fledged organization for
Commissioning, Engineering Design, Qualification / Validation and
Regulatory Affairs of the cGMP Biopharmaceutical, Medical Devices,
Pharmaceutical and Food 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. Our employees are highly qualified in the industry who are
continually trained in the latest developments in the field.



NCS Pharmaceuticals provides validation services independently or in
conjunction with commissioning operations in order to optimize project
cost and time. NCS Pharmaceuticals will deliver the services required
to meet your specific needs. NCS Pharmaceuticals offers the following
activities:

  • Design Reviews

  • Validation Master Plans

  • Commissioning Plans

  • User Requirement Specifications (URS)

  • Functional Requirement Specifications (FRS)

  • Detailed Design Specifications (DDS)

  • Factory Acceptance Test (FAT)

  • Site Acceptance Test (SAT)

  • Commissioning Protocols

  • Installation Qualification (IQs) Protocols

  • Operational Qualification (OQs) Protocols

  • Performance Qualification (PQs) protocols

  • Cleaning/Sanitization Validation Protocols

  • Computerized Systems Validation

  • Standard Operating Procedures (SOPs)

  • Employee cGMP Training

  • Equipment History Files Analytical Methods Validation

  • Site Validation Execution Site

  • Commissioning Execution

  • Final Reports Scheduling/Estimating and Project Management

  • cGMP Auditing Services  
Copyright ® 2007 NCS Pharmaceuticals. All Rights Reserved.
Labs Pictures