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 in our 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 LLC.
2009 Kramer Rd., Gibsonia, PA 15044
Fax: +1 (866) 658-1445
in**@***************al.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.
