GMP/GLP Bioanalytical Services Help Clients’ Regulatory Compliance
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.
- 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.