MRIGlobal is dedicated to helping clients meet today’s demands for regulatory compliance.

MRIGlobal offers analytical method development and validation, and regulatory services and support to the chemical, pharmaceutical, and bio-pharmaceutical industries operating under Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) guidelines.

 Our Capabilities:

• Small molecule, peptide, and protein active pharmaceutical ingredient (API) identification and formulation
• Composition and identity testing
• Method development and validation, following U.S. Food and Drug Administration guidelines
• Quantitative analysis of drugs and metabolites in biological matrices, formulation, stability-indicating method development and validation, bioanalytical sample analysis, structural identity and confirmation
• Pharmaceutical analytical testing and stability testing
• Product release testing, including physical testing of vaccine formulations using Polymerase Chain Reaction (PCR) and genetic sequencing
• Extensive chromatography, mass spectrometry, and spectroscopy laboratories, and dedicated molecular facilities

 MRIGlobal’s GMP/GLP Bioanalytical Services Successes:

• Bioanalytical matrices testing: MRIGlobal has developed expertise with a variety of matrices including whole blood, plasma/serum, lung, urine, saliva, amniotic fluid, feces, and tissues.
  
  
• Bioanalytical methods development: MRIGlobal develops and validates analytical methods for assessment of candidate drugs and metabolites, and develops immunoassay methods for pharmaceutical and bio-pharmaceutical industries.
  
  
• Regulatory support: MRIGlobal has extensive experience in supporting industrial clients with a range of biological and chemical testing in compliance with GMP/GLP regulations, including testing for fungal, viral, and bacterial contamination, chemical and toxin contamination, and purity/homogeneity analyses.
  
  
• Pesticide regulation: MRIGlobal has helped companies comply with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). MRIGlobal performs bioanalytical and chemistry tests under GLP, and supports registration, preregistration and other regulatory requirements.