About Gateway Analytical
Curiosity + Expertise = Innovation.
At Gateway Analytical, we’re more than just an FDA-registered cGMP analytical laboratory; we’re your partners in safety and innovation. Our expertise in parenteral testing services cover a broad range of services such as process and formulation development, product-package validation, clinical and commercial manufacturing, visual inspection, quality control, release testing, and beyond.
FDA-inspected, cGMP-certified, and DEA-licensed, reflecting our commitment to unparalleled quality, safety, and regulatory compliance.
Envision the possibilities. Dive into the details, then reach out so we can embark on this exciting journey together.
Download our in-depth informational and case studies about Gateway Analytical methodology, services and capabilities.
Interested in learning more about the latest from Gateway Analytical and our team? Check out our News & Events section for weekly updates.
You should never let expertise go to waste. That’s why our team also devotes time to building and supporting a healthy ecosystem for the entire industry to thrive.
When carefully building our team of expert scientists, we may have underestimated their ambition. In addition to working with you on unique projects, they’re hard at work pioneering new techniques to better understand and interpret the happenings of the microscopic world. You can read our latest publications, view posters and presentations from technical conferences, and even watch videos we’ve created.
Accelerating Access to Life-Saving Medicines
Our greatest assets are the investments we make in our people, our facility, and our partnerships. We invest in the people who are essential to our success & our scientists are eager and committed to our mission and culture. Boasting certifications and accreditations from leading institutions; partnership drives Gateway Analytical, with our strongest partnerships forged between CDMOs, license holders, and pharmaceutical companies with the aim to advance access to life-saving medicines for patients.
Empowering Your Journey Toward Enhanced Patient Care
Covering every stage of the drug development journey with our state-of-the-art, FDA-inspected, cGMP-compliant facilities designed to minimize bottlenecks and maximize success.
Gateway Analytical: Your Partner in Precision
With decades of expertise on the pathway of pharmaceutical drug development, our mission was to establish a full-service analytical laboratory that stands apart in excellence. Proudly, we’ve earned recognition through audits and certifications from institutions like the U.S. Food and Drug Administration (FDA), the U.S. Drug Enforcement Administration (DEA), the International Organization for Standardization (ISO), Health Canada, and the European Medicines Agency (EMA). These accolades reflect our deep commitment to delivering unparalleled quality, ensuring safety, and adhering to stringent regulatory standards.
Early-Phase Development
Container Closure
Integrity Testing
Particulate
Analysis
Medical Device
Analysis
Extractables
& Leachables
Empowering Your Journey Toward Enhanced Patient Care
Covering every stage of the drug development journey with our state-of-the-art, FDA-inspected, cGMP-compliant facilities designed to minimize bottlenecks and maximize success.