| Protecting Drug Products. Preserving Patient Safety. |
| Introducing Advanced Chromatography Methodologies for Investigations & Analytical Method Development & Validation Services: Gateway Analytical delivers advanced chromatography solutions tailored for the pharmaceutical and medical device industries. Our LC-MS/MS, GC-MS, and QTOF-MS platforms support impurity profiling, nitrosamine detection, PFAS identification, leachables and extractables analysis, and early-phase biologics support. Each method is developed with regulatory alignment in mind, ensuring accuracy, compliance, and product safety. Partner with us to accelerate development, mitigate risk, and achieve market readiness with confidence. Triple Quadrupole LC-MS/MS: Custom methods for trace-level leachables, genotoxic impurities, and targeted contaminants. GC-MS for PAHs: Detection and quantification of polycyclic aromatic hydrocarbons, especially from carbon black and elastomers. Early Biologics Support: High-resolution QTOF-MS workflows for peptide biologics; HCP profiling and leachables analysis. Nitrosamine Testing: LC-MS/MS methods aligned with FDA, EMA, and ICH M7 guidelines, with optional client validation. PFAS Detection: In-development LC-MS/MS workflows for identifying PFAS in pharmaceutical packaging. Small Molecule Analysis: Custom impurity profiling and potency assays using LC-MS/MS, GC-MS, and QTOF-MS. Comprehensive Screening: GC-MS and LC-MS workflows for volatile/non-volatile extractables and unknown compound identification. Platform-Wide Custom Validation: Flexible method validation approach across all instruments, following ICH Q2(R2) standards. Gateway Analytical ensures your products meet regulatory demands, protect patients, and reach the market with confidence. Let’s advance safety together. Contact us at (724) 443-1900 or in**@***************al.com. |
