CONTACT
Accelerating Your Journey Together.

With quality as our cornerstone, Gateway Analytical has remained your 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 for over 15 years. 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!

From early-phase development to commercial release, Gateway Analytical provides the specialized testing and technical insight required to ensure the safety, quality, and regulatory success of your parenteral programs. We offer a full suite of specialized analytical services designed to meet the evolving needs of the pharmaceutical industry.

Looking to accelerate your project kickoff? Click the button below to use our new interactive submission form to provide detailed context on your project. This will alow our technical team to reach out with ayour own custom-tailored strategy.

Interactive Submission Form

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

Downloadable 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: in**@***************al.com

Sample Submission Form

Extractables
& Leachables

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

LEARN MORE

Container Closure
Integrity Testing

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

LEARN MORE

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.

LEARN MORE

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.

LEARN MORE

Early-Phase Development

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

LEARN MORE