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.

 

ASCLD/LAB-International

(American Society of Crime Laboratory Directors/Laboratory Accreditation Board) Approved by the Texas Department of Public Safety, Approved by the Maryland Department of Health & Mental Hygiene.

View Certificate & 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 17025:2005

"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.