Comprehensive Particulate Analysis
At Gateway Analytical, our core mission is to assist pharmaceutical and biotechnology companies in bringing their clinical or commercial drug products to market by leveraging our FDA-registered and inspected cGMP laboratory to rapidly identify foreign particulate matter. For over a decade, we have been industry leaders, offering the fastest turnaround times in the market for foreign particulate matter identification testing. Our dedication to speed and accuracy ensures that our clients can rapidly address particulate concerns, maintaining the highest standards of product quality and patient safety.
Gateway Analytical: Your Partner in Precision
The presence of visible and subvisible particulate matter is a critical test in the manufacturing of pharmaceutical and biotechnology drugs. These particles often originate from raw materials, disposable containers, single-use systems, container-closure system components, and are most frequently detected in the final drug products. Given the potential impact of particulate matter on product quality and patient health, it is imperative to effectively identify and eliminate these particles.
Navigating Complexities,
Delivering Clarity
At Gateway Analytical, we are committed to accelerating the release of pharmaceutical and biotechnology products by rapidly identifying foreign particulate matter through a variety of methods. Our advanced techniques ensure precise detection and thorough inspection, paving the way for effective remediation.
Turn to Gateway Analytical for unparalleled expertise in managing particulate matter challenges in your pharmaceutical products.
Managing Particulate Matter Challenges
Regulatory bodies have long focused on the issue of particulate matter in drug production. Our approach is informed by a wealth of industry resources, including compendia, guidance documents, technical reports, and publications, ensuring we’re at the forefront of particulate analysis.
At Gateway Analytical, we delve deep into the microscopic world of particulates, transforming the invisible into insights. Our state-of-the-art particulate analysis laboratory empowers pharmaceutical and biotechnological advancements, ensuring your products meet the highest standards of purity and safety.
