Pharmaceuticals
RJ Lee Group is an ISO-compliant, FDA-registered laboratory with a well-established quality system for pharmaceuticals. 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.
Pharmaceutical 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