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Quality Program

Reliability at Our Core.

The Impact Analytical quality program is certified to ISO 9001:2015 registered by DQS Inc. Upon client request, analytical services and method validations can be conducted in compliance with Good Laboratory Practice (GLP) regulations required by the EPA or FDA or current Good Manufacturing Practice (cGMP) regulations required by the FDA. Impact Analytical is a registered facility with the FDA (Registration Number 3004518270).

Impact Analytical is also licensed with the Drug Enforcement Administration (DEA) to maintain and test controlled substances under DEA Schedules 1, 2, 2N, 3, 3N, 4 and 5.

For more information, visit our GLP/cGMP webpage.

Clients are always welcome to schedule an on-site visit to conduct an audit of our laboratories and operations. We have hosted numerous successful customer quality audits.

Our dedicated staff personally ensures data reliability. If you have questions about our quality program, please e-mail one of the members of our quality team:

    • Quality Manager – Sarah Diener
    • Senior Quality Assurance Leader – Kerry Pacholke
    • Quality Assurance Auditor – Tom Buter
ISO FDA DEA

A downloadable version of our ISO certificate can be found here: 
ISO Certificate

QM15 10000583 QM15 EN

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