Unknown Particulate? High-Risk Batch? No Time to Wait.
When a proteinaceous particle appears during fill, inspection, or within the final container, it signals more than just a defect, it indicates a potential threat to product integrity, patient safety, and regulatory approval. Immediate, informed action is critical.
Gateway Analytical delivers rapid, expert-led analysis of visible and subvisible particles using advanced methodologies including LC-MS/MS, GC-MS, and QTOF-MS. Our investigative workflows are designed for high-impact resolution, providing root cause determination, materials compatibility evaluation, and regulatory submission-ready documentation.
This isn’t routine testing—it’s precision-driven science built for urgent decision-making in high-risk scenarios. From materials characterization and batch release to contamination control, our team brings deep scientific insight and unmatched responsiveness.
Submit your sample for priority testing. Speak directly with a Gateway scientist to receive expert guidance and timely results tailored to your needs.
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.
