Accelerating Medicine Your Journey Tomorrow Together
Precision Analytical Testing for Early-Phase Pharmaceuticals & Medical Devices
Gateway Analytical is a cGMP laboratory registered and inspected by the FDA. We are not just a testing laboratory but your partners in innovation and safety. Our expertise is parenteral testing services, which cover a broad range of services such as process and formulation development, product-package validation, clinical and commercial manufacturing, visual inspection, quality control, and release testing.
Early-Phase Development
Container Closure
Integrity Testing
Particulate
Analysis
Medical Device
Analysis
Extractables
& Leachables
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.
Driving Pharmaceutical Progress With Precision
At Gateway Analytical, we specialize in providing innovative solutions tailored to the unique challenges of our clients in pharmaceutical & healthcare industries. Our team of expert scientists and analysts are committed to delivering accurate, reliable, and actionable insights that help our clients achieve their goals and advance their research. 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.
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, therapeutic developers, and pharmaceutical companies with the aim to advance access to life-saving medicines for patients.
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.