Accelerating Your Journey Together.

Gateway Analytical is a trusted partner in innovation and safety, proudly operating as a cGMP-compliant laboratory, registered and inspected by the FDA, ensuring the highest standards of analytical testing services. Our expertise includes process and formulation development, product-package validation, clinical and commercial manufacturing, visual inspection, quality control, and release testing. We’re here to support your journey from development to delivery, ensuring quality and safety every step of the way!

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.

Sample Submission Form

Ensure your samples are processed quickly and effectively by downloading our easy-to-use Sample Submission Form. This form helps you provide all the necessary details, ensuring accurate and timely testing. When you’re ready, you can submit this form to our email: info@gatewayanalytical.com

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.

Container Closure
Integrity Testing

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

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.

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.

Early-Phase Development

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