Pharmaceutical and Biotechnology
Maxxam Analytics’ pharmaceutical division is an industry leader in GMP impurity measurements in raw materials and finished drug products such as biologics and small molecule pharmaceuticals.
Our FDA-audited and OECD GLP recognized facility holds Health Canada’s Pharmaceutical Testing license and is frequently audited by our current and prospective customers.
CMC Support Services (cGMP)
- Method Development and Optimization
- Method Validation and Qualification (ICH, BMV, USP, Custom)
- Method Transfer
- Process-related impurities in Biologics
- Cleaning Validation Analysis
- Elemental Impurities as per new USP <233>
- Residual Solvents USP <467>
- Compendial Testing
- Extractables/Leachables studies
- Stability Testing according to ICH guidelines
- Release Testing
Bioanalytical Services (GLP)
- Metallo-Drugs bioanalysis (GLP)
- Plasma Protein binding of Metallo-drugs
