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Services Regulatory Testing

Material and product testing under FDA or EPA guidelines.
Impact Analytical is a GLP-compliant, cGMP-registered, DEA-licensed, and ISO 9001:2008-certified (with ISO 9001:2015 certification in progress) laboratory. The combination of our certifications, robust quality program, experience, and technical expertise make us exceptionally qualified to execute regulated studies. We are able to comply with FDA, EPA, REACH, and OECD guidelines. All of our instrumentation is qualified under cGMP requirements and every analyst receives annual regulatory training. Whether you are starting from scratch, have a protocol for us to follow, or a validated method to execute, Impact Analytical investigators work with our customers and quality assurance unit to generate study plans that meet your needs while remaining in compliance. Our FDA and EPA facility audits, to date, have resulted in no major or minor findings. For more information, visit our quality section. Or to discuss a project, please contact us.

Examples of FDA and EPA regulated studies we’ve performed in the past include:

Related Whitepaper

Adding Value by Integrating cGMP with an ISO 9000 Quality Management System
October 2016
By John MacLauchlan, Quality Systems, Impact Analytical

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