LGM Pharma delivers comprehensive analytical and microbiological testing services to support drug development, manufacturing, and compounding for pharmacies, outsourcing facilities, and pharmaceutical companies. With cGMP-compliant laboratories and a team of over 60 QA/QC and analytical specialists, LGM provides validated, high-quality testing aligned with global regulatory standards. Services cover a broad spectrum of needs including assay, identification, impurity profiling, residual solvent analysis, and endotoxin testing for both drug substances and products.
Their recently expanded capabilities include rapid sterility testing and bacterial endotoxin testing (BET), which are ideal for sterile compounds such as injectables. This enables faster turnaround times and 5-day incubation versus traditional 14-day methods, facilitating quicker submissions and product launches. LGM uses modern instrumentation such as ICP-MS, UPLC, and PCR-based technologies to ensure high accuracy and reproducibility across tests.
Key services include:
- Analytical method development and validation in compliance with ICH guidelines
- Stability-indicating method development for various formulations
- Rapid microbiological assays including bioburden and BET
- Elemental impurities, particle size analysis, and spectrophotometric testing
- Regulatory support for 503A, 503B, and 505(b)(2) pathways
LGM Pharma’s integrated approach allows clients to consolidate their supply chain and reduce outsourcing complexity by offering both standalone testing and full CDMO support.
