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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

Laboratory Services:

Finished Product Testing, Raw Material and Container Testing (ICH and USP)
  • R&D Projects
  • Method Development, Qualification and Method Validation 
  • Method Transfer and Method Verification
  • Quality control release testing
  • Remedial and Retrospective Method Validation
  • Forced Degradation Studies
  • Product and Process related impurity 
  • Dissolution USP <711> Method Development and Routine Analysis
  • Stability indicating methods
  • Process and/or product troubleshooting
  • Complete Compendia Testing (USP,EP,BP,JP,FCC and ACS testing)
  • Metals Analyses (AA,GFAA, and ICP)
  • Elemental Analysis
  • Elemental Impurities
  • USP <467> Residual Solvent Testing
  • HPLC,GC and IC analyses
  • Wet Chemistry Analyses
  • Karl Fisher Analyses
  • Spectrophotometric Analyses (FTIR and UV/VIS)
  • Viscosity analysis (Brookfield, Capillary)
  • Container Testing
  • Glass Testing per USP/EP/JP
  • Light Transmission
  • Package Integrity
  • Plastic Testing per USP/EP/JP
  • Rubber Closure Testing per USP/EP/JP
  • Cleaning Studies
  • Particulate Matter - light obscuration and microscopic
  • Cleaning Validation  
Microbiology
  • Method Development, Transfer and Validation
  • AAMI Sterilization Validation
  • Environmental Monitoring
  • Microbial Examination Testing
  • Cleaning Validation
  • Antimicrobial Effectiveness Testing
  • Disinfectant Efficacy Studies
  • Biological Indicator Testing
  • Sterility testing by direct transfer
  • Sterility testing by membrane filtration (vacuum or SteritestT)
  • Preservative Challenge
  • Container Integrity Testing - Dye Ingress and Microbial Ingress  
Stability Studies
  • Customized and complete ICH stability storage services
  • Protocol and summary report writing
  • Drug substance and drug product stability testing
  • Accelerated, long- term, and comparative stability studies
  • Forced Degradation Studies
  • Stability indicating method development and validation services  
Formulation Services
  • Liquid finished product formulation development (emphasis on parenterals)
  • Lyophilized finished product formulation development
  • Technology transfer to cGMP manufacturing
  • Thermal analysis for lyophilized formulation development - DSC, Freeze Drying Microscopy (FDM)
  • Generic ANDA Product development for injectables - including formulation and analytical method development
  • Freeze-Thaw, temperature excursion, and photostability studies for finished products
  • Pre-formulation - DSC, XRD, TGA, pH solubility, Particle size assessment
  • In-vitro exchange method development/validation (Dissolution APP-4, Topical Dissolution cell with Dissolution APP -2)
  • De-formulation - unknown excipient concentration determination for various salts, fatty acids, co-solvents


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