Leading the Industry in Quality, Safety, and Compliance
Gateway Analytical excels in ensuring top-tier quality and safety for pharmaceutical products and medical devices on their journey to market. From the largest brands in pharmaceuticals, to early-phase drug exploration and development, we are a trusted leader in the field of analytical testing. Our extensive range of testing and early-phase development services help you navigate the complexities of regulatory compliance effortlessly. Our state-of-the-art labs provide comprehensive testing, including Extractables and Leachables (E&L) studies, Container Closure Integrity Testing (CCIT), Particulate Analysis and beyond. These critical tests identify contaminants, ensure packaging integrity, and maintain product purity, all while upholding the highest standards.
Regulatory Expertise: Simplifying Compliance
Navigating the stringent regulatory landscape is easier with Gateway Analytical. Our deep understanding of FDA and ICH requirements ensures your products not only comply but also gain strategic insights for smoother submissions and approvals.
Innovative Solutions to Industry Challenges
Specializing in solving industry-specific issues like Glass Delamination, we proactively identify and mitigate risks to maintain product safety and efficacy. Our customized solutions are tailored to meet your unique needs, ensuring optimal outcomes.
Partnership for Success
At Gateway Analytical, we see our role as a partner in your journey to excellence. Our team collaborates closely with you to provide solutions that address your specific challenges, positioning us as a trusted partner in the pharmaceutical and medical device industries. Gateway Analytical is dedicated to advancing healthcare quality and safety through comprehensive testing and innovative solutions. Discover the Gateway Analytical difference and join us in our mission to elevate healthcare standards. Contact us to learn how we can help you achieve the highest levels of excellence in your products. Together, let’s pave the way for a safer, more effective healthcare future.
Explore how Gateway Analytical can support your journey to market. With over a decade of expertise in parenteral testing, we cover a broad range of services from process and formulation development, product-package validation, clinical & commercial manufacturing, to visual inspection, quality control, and release testing. Reach out to our experts at (724) 443-1900 or info@gatewayanalytical.com, or feel free to visit our contact page to connect with us!
