When it comes to healthcare, ensuring product quality, efficacy, and safety is not just a requirement but a commitment to patient care. Gateway Analytical stands at the forefront of this commitment, offering a comprehensive suite of services tailored specifically for pharmaceuticals and medical device development. Our advanced testing methodologies, coupled with unparalleled regulatory support, provide the foundation for the highest standards of quality and safety.
At Gateway Analytical, we understand that each product’s journey from development to market is unique, filled with complex challenges that require precise and reliable testing solutions. Our state-of-the-art laboratories are equipped with cutting-edge technology, enabling us to offer a wide array of analytical services. From Extractables and Leachables (E&L) studies to Container Closure Integrity Testing (CCIT) and beyond, our testing methodologies are designed to uncover the invisible, ensuring your products comply with regulatory standards.
The regulatory landscape for pharmaceuticals and medical devices is ever-evolving, posing a significant challenge for manufacturers. At Gateway Analytical, our regulatory support services are designed to navigate these complexities, ensuring your products meet all necessary regulatory requirements helping you stay ahead of the latest regulations, offering insights and support throughout the regulatory approval process. Our expertise also extends to regulatory frameworks, including the United States Pharmacopeia (USP) standards and International Organization for Standardization (ISO) methods. This collaborative spirit extends to our partnerships with clients, where we offer customized solutions tailored to specific needs and challenges. Through continuous research and development, we strive to stay at the cutting edge of analytical testing, offering innovative solutions that drive the industry forward.
When it comes to pharmaceuticals cleared by the FDA, the margin for error is subvisible. Quality, safety, and compliance are not just goals but absolute requirements. At Gateway Analytical, we make it our mission to ensure that your products not only meet but exceed the highest standards of excellence in regulatory compliance. Explore our comprehensive suite of services and discover how our advanced testing methodologies, regulatory support, and team of experts can elevate the quality and safety of your products.
Partner with Gateway Analytical and take a step towards excellence in every aspect of your product’s journey!