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PFAS Testing Capabilities

Supporting Regulatory-Driven Excellence in Pharmaceutical and Medical Device Testing

Gateway Analytical is developing advanced LC-MS/MS-based workflows for detecting and quantifying PFAS in pharmaceutical packaging and contact materials. These workflows target regulatory scrutiny and patient safety, offering high sensitivity for trace-level detection. As industry focus on PFAS grows, our expanding capabilities reflect Gateway’s proactive approach to emerging contaminants.

Partner with us to ensure your materials meet evolving safety standards with scientific rigor and regulatory foresight.

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Covering every stage of the drug development journey with our state-of-the-art, FDA-inspected, cGMP-compliant facilities designed to minimize bottlenecks and maximize success.

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Early-Phase Development

Comprehensive packages designed to navigate clinical & regulatory complexities of parenteral product-package and container-closure development, from concept to market readiness.

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Container Closure
Integrity Testing

Quantitative, non-destructive, deterministic leak detection technologies for products stored in vials, syringes, cartridges, flexible containers, and bottles.

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Particulate
Analysis

Multi-analytical methods to count, size, and characterize visible and subvisible particulate matter in pharmaceuticals, disposable containers, single-use systems, raw materials, and medical devices.

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Medical Device
Analysis

Rigorous studies focused on enumerating particulate matter and identifying potential chemical compounds that could migrate from medical devices into the environment or directly impact patient health.

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Extractables
& Leachables

Studies aimed at identifying potentially harmful compounds in manufacturing components and final containers to ensure the safety and efficacy of pharmaceutical products.

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