Pharmaceutical Testing Services

 

We provides chemical, microbial, stability and sterility testing on a vast variety of finished drug products of "clients and their competitorsfrom FDA Registered; or Health Canada approved laboratories. The samples are taken, packaged, processed, transported, received and tested by or under the direct supervision of duly qualified, trained and experienced personnel. The staff is trained to understand and follow the standards specified in USP, and guidelines in WHO, FDA, Health Canada, ICH or ISO for these procedures, whenever they are available or applicable. We manage testing of:

At LYF Research, we manage the analysis from independent, neutral, scientific and technically sound labs that are FDA Registered, cGMP/GMP compliant, Health Canada approved, and/or ISO 17025 accredited. Our expert testing labs use the following major state-of-the-art instruments.

  • Nuclear Magnetic Resonance (NMR)
  • Scanning Electron Microscopy (SEM) 
  • Size exclusion chromatography (SEC)
  • Energy Dispersive X-ray Spectroscopy (EDS) 
  • Transmission Electron Microscopy (TEM)
  • liquid chromatography-mass spectrometry (LC-MS)
  • Optical/Stereo Microscopy
  • Raman Microscopy
  • FT-IR with Attenuated Total Reflectance (ATR) accessory
  • High performance liquid chromatography (HPLC)

The experienced scientists of our associated labs are dedicated to deliver accurate, reliable and timely results. We offer competitive testing including rush service. Our analytical team and regulatory consulting group work together to ensure the highest level of quality for your pharmaceutical products. We are also able to manage the following testing services:

    Chemistry Services

    • Release Testing
    • Testing after expiry date for surveilance and review
    • Extractables and Leachables
    • Metals Analysis
    • Method Development and Validation
    • Impurities Testing

    Stability Services

    • Full ICH Stability Studies
    • GMP Storage

    Biochemistry Services

    • Method Development & Validation
    • Residual Impurity Testing

    Microbiology Services

    • Microbial Limit Testing
    • Sterility Testing
    • Particulate Matter by Light Obscuration Particle Count
    • Microbial Identification
    • Endotoxin Determination
    • Antibiotic Potency Testing

    Facility Validation Support

    • Water Testing
    • Environmental Monitoring
    • Disinfectant Studies
    • GMP Process Validations
    • Cleaning & Other

    Other Specialty Services

    • Regulatory Consulting
    • Container Testing
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