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Accelerating Your Journey Together.

Gateway Analytical provides personal attention, timely responses, and flexible project design — all from seasoned experts and eager customer support staff. Connect with us today and let us know how we can help you and your organization achieve success.

Gateway Analytical is a cGMP laboratory registered and inspected by the FDA. We are not just a testing laboratory but your partners in innovation and safety. Our expertise is parenteral testing services, which cover a broad range of services such as process and formulation development, product-package validation, clinical and commercial manufacturing, visual inspection, quality control, and release testing.

Gateway Analytical LLC.
2009 Kramer Rd., Gibsonia, PA 15044
Fax: +1 (866) 658-1445
info@gatewayanalytical.com

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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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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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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