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.
We Take Our Expertise Seriously
Gateway Analytical is committed to quality, transparency, and partnership. That’s why we list all of our certifications from leading institutions right here, in one place, with easy-to-understand descriptions to get past the technical lab jargon.
Quality Standard | Description | Certificate (if applicable) |
21 CFR parts 210 & 211 | These U.S. FDA standards cover current good manufacturing practice in manufacturing, processing, packaging, or holding of drugs and finished pharmaceuticals. |
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21 CFR part 820 | This U.S. FDA standard covers quality system regulation and establishes cGMP requirements for medical devices. |
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cGMP-compliant | Current Good Manufacturing Practices establish rigorous quality management guidelines for companies working with pharmaceutical drugs. |
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FDA Registered & Inspected | Our facility’s current inspection was conducted on 01/15/2015 and can be found in the FDA inspection database. |
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ISO 17025:2017 | General requirements for the competence of testing and calibration laboratories. | View Certificate & Scope of Accreditation |
ISO 9001:2015 | This establishes the requirements for quality management systems. | View Certificate |
ICH Q7 | This guideline establishes good manufacturing practice for active pharmaceutical ingredients. |
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DEA-licensed | This allows us to conduct business with controlled substances as classified by the DEA. |
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Our transparency doesn’t end there. If you want to arrange a tour of our analytical lab and facilities, then contact us today
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.