An Established Quality System Committed to Customer Satisfaction
At Gateway Analytical, we take every effort to ensure the quality of our 17,000 square feet (1,580 square meters) laboratory environment. Our quality policies and objectives are documented and implemented through an established quality management system. We consistently work to create and improve the effectiveness of our quality system through the use of established controls.
Gateway Analytical meets the requirements of the following quality standards:
- 21 CFR parts 210 & 211
- 21 CFR part 820
- ASCLD/LAB-International (Certificate & scope of accreditation)
– Approved by the Texas Dept. of Public Safety (Approval letter & scope of work)
– Approved by the Maryland Department of Health & Mental Hygiene (Approval letter & scope of work)
- FDA Registered & Inspected (Inspection letter)
- ISO 17025:2005 (Certificate & scope of work)
- ISO 9001:2008 (Certificate)
- ICH Q7
- DEA licensed (Certificate)
The quality system is designed to ensure production and reporting of reliable, accurate data. The following quality objectives are tracked, trended and reported on quarterly:
- Reporting Accuracy
- On-Time Reporting
- Customer Satisfaction
We stand by our quality system, and welcome tours of our laboratory facilities. Contact us at
+1 (724) 443-1900 to arrange a tour.
If you would like to submit a sample please download and submit our sample submission form.