Accelerating Medicine Your Journey Tomorrow Together
Precision Analytical Testing for Early-Phase Pharmaceuticals & Medical Devices
At Gateway Analytical, we’re not just an FDA-registered & DEA-licensed, cGMP-compliant laboratory; we’re your partners in innovation and safety. 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.
Early-Phase Development
Container Closure
Integrity Testing
Particulate
Analysis
Medical Device
Analysis
Extractables
& Leachables
Gateway Analytical: Your Partner in 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.
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.
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.