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.
While some of the following standards may only be required for specific fields (pharmaceuticals or forensic crime labs), our quality management systems cover all of our business segments. Gateway Analytical meets the requirements of the following quality standards:
|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”.|
|21 CFR part 820||This U.S. FDA standard covers quality system regulation and establishes cGMP requirements for medical devices.|
|ANAB 17025:2017||Forensic Science Testing and Calibration Laboratories Accreditation Requirements (AR3125), Approved by the Maryland Department of Health & Mental Hygiene.||View Certificate of Accreditation View Scope of Accreditation|
|cGMP-compliant||Current Good Manufacturing Practices establish rigorous quality management guidelines for companies working with pharmaceutical drugs.|
|FDA Registered & Inspected||Our facility’s current inspection was conducted on 01/15/2015 and can be found in the FDA inspection database.|
|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.|
|DEA-licensed||This allows us to conduct business with controlled substances as classified by the DEA.||View Certificate|
Our transparency doesn’t end there. If you want to arrange a tour of our analytical lab and facilities, then contact us today.