Provides customized laboratory and clinical manufacture services to pharmaceutical and allied industries

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MICROBIOLOGICAL DEVELOPMENT

  • All Microbiological Aspects of Product Development, Manufacture & Testing
     
  • Support for Sterile Product Development and Technology
     
  • Sterilization Cycle Development and Validation Studies
     

  • Development/Validation & Testing of Microbio Methods for Sterility, Microbial Limits, Bacterial Endotoxin & Preservative Evaluation/Effectiveness

  • Development & Testing of Antibiotic Microbioassays; Environmental Monitoring; Evaluation of Disinfectants and Sterilizing Agents
     
  • Special Expertise in the Pre-clinical and Clinical Development & Evaluation of Antibiotics and Antiseptics
     
  • Sterile Filter Validation and Microbiological Container/Closure Integrity Evaluation Studies
     
  • Microbiological Development/Testing of Controlled Drug Substances, Schedules II through V, and their Formulations
     
  • Troubleshooting &Problem Solving Expertise in Product Contamination and Infection Control Matters
     
  • Technology Transfers & Regulatory Documentation

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