SGS Life Sciences Services

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SGS Life Sciences Services?

Overview

 
SGS Life Science Services is a leading contract service organization providing clinical research, pharmaceutical development, biologics characterization, biosafety, and quality control testing. Operating 20 laboratories in 11 countries, SGS represents the broadest, wholly-owned, global network of contract analytical laboratories. SGS delivers solutions for pharmaceutical, biologics, and medical-device manufacturers, SGS provides clinical trial management (Phase I to IV) and services encompassing, data management, biostatistics, and regulatory consultancy. SGS also offers GMP/GLP contract laboratory services that include:
  • Quality Control testing of raw materials, APIs, and finished products
  • Monograph testing (USP, EP, BP, and JP)
  • Analytical method development and validation
  • Antibody product analysis
  • Bioanalysis, mass spectrometry and immunoassays
  • Biologics safety testing (endotoxin, virus and mycoplasma)
  • Cell-line characterization
  • Comparative Dissolution Profiling
  • Container testing (extractables and leachables)
  • Environmental Monitoring
  • Glycosylation Analysis
  • Host-cell impurity testing
  • Medical-device testing
  • Microbiological testing
  • Protein/peptide analysis and quantification
  • Stability testing according to ICH/ASEAN guidelines or customer specifications     
  • Water System validation

Standards & Methodologies

  • HPLC
  • GC
  • IC
  • Wet Chemistry
  • Karl Fischer
  • FTIR
  • UV/VIS
  • DSC
  • Freeze Drying Microscopy (FDM)
  • XRD
  • TGA
  • Dissolution APP 2 & 4

Qualifications, Certifications, Accreditations & Licenses

FDA registration number: 14-18028
ISO registration (9001:2008) number: FS 40654
DEA license number: RS0348703 (for schedules 1, 2, 2N, 3, 3N, 4, 5)

Industries Served

  • Life Sciences
  • Medical Devices
  • Pharmaceutical

Testing Types

  • Analytical
  • Analytical Chemistry
  • Environmental Microbiology
  • Molecular Biology

Publications

SGS Life Sciences Services has not posted any publications.

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