Impact Analytical is an FDA-registered
facility. We are also DEA-licensed
and registered with LARA in the State of Michigan to handle schedule 1-5 controlled substances. Our team of scientists and management work together to ensure your project and samples and handled correctly and meet with the requirements of these regulatory bodies. We conduct all of our testing on controlled substances in accordance with current Good Manufacturing Practices (cGMP). For more information, visit our GLP/cGMP
The Impact Analytical quality program is certified to the ISO 9001:2015 quality system standard. 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).
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.
Impact Analytical can receive controlled substances in class 1 and 2 from any company provided the samples are prepared and shipped in accordance with DEA form E222.