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Our scientists use rationalized analytical methods to support regulatory compliance and quality control, providing solutions that span the entire product life cycle.


Sean M. Ruane

We work closely with our clients to understand the issues surrounding each unique situation.

Sean M. Ruane Industry Contact

RJ Lee Group is an ISO-compliant, FDA-registered laboratory with a well-established quality system. Our experts use and develop validated protocols and execute them in a cGMP-level environment to investigate your problem and provide resolution. In addition to investigating your particulate matter, we provide pharmaceutical failure analysis and design a program for future contamination control based on your process. Industrial hygiene, containment, and toxicology services are also available.

Services & Capabilities

  • Foreign Particulate Matter (FPM) Analysis
    • Contamination Identification
    • Root Cause Analysis
    • Source Determination
    • Surface Defect Analysis
    • Particular Morphology Evaluation
    • Particle Size Analysis
  • Regulatory Assistance with USP Testing, CAPA Investigations, OOS Investigations
  • Industrial Hygiene, Containment, Validation, and Toxicology Services

Instrumentation & Techniques

  • Fourier Transform Infrared Spectroscopy (FTIR)
  • Scanning Electron Microscopy (SEM)
  • Energy-dispersive X-ray Spectroscopy (EDX)
  • Optical Polarized Light Microscopy (PLM)
  • X-ray Diffraction Microscopy (XRD)
  • Inductively Coupled Plasma Mass Spectrometry (ICP)
  • Gas Chromatography (GC)
  • Raman Microscopy

For more information, please call us at 1.800.860.1775, option 2, then 4, or click below.






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