| Particle Investigations and Materials Characterization Powered by LC-MS/MS, GC-MS, and QTOF-MS — Delivered with Regulatory Precision. |
| When a proteinaceous particle emerges during fill, inspection, or in the final container, it doesn’t just raise questions. It halts progress. These events signal potential risk to product integrity, patient safety, and regulatory timelines. Gateway Analytical responds fast with science that doesn’t second-guess. Our team delivers expert-led investigations of visible and subvisible particles using cutting-edge analytical tools, including LC-MS/MS, GC-MS, QTOF-MS, and complementary techniques. Whether you’re seeking root cause, supporting a deviation report, or preparing for regulatory scrutiny, we provide the defensible answers you need with speed and clarity. At Gateway, we don’t do routine testing. We deliver high-impact analytical support where speed, accuracy, and insight matter most. Our capabilities include: Advanced materials characterization Root cause investigations Batch release testing Regulatory submission-ready reports From development through commercial release, we serve as a trusted partner to pharma and biotech teams navigating high-stakes moments. You’ll experience concierge-level service paired with collaborative scientific excellence so you can move forward with confidence and compliance. 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. |
