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Providing Exceptional Quality Compliance Services to Meet Your Regulatory and Business Needs.


“The consultants at 80/20 Quality Consulting have been our consulting Quality Assurance and Quality Control specialists for several years now. Their knowledge of GLP, GMP, SOP and other FDA rules and regulations are extraordinary and exemplary. It was because of our consultant’s understanding of the FDA’s section 21 CFR, Part 58, Good Laboratory Practice for Non-Clinical Laboratory Studies that we are now totally GLP-compliant. I would recommend them, without hesitation, to anyone in need of a QA/QC Specialist.”

James Staruk

President and CEO, Mass Histology Services

“Our consultant and 80/20 Quality Consulting did a great job on preparing us for ISO 13485:2016 audit. The consulting group is very professional and knowledgeable.”

Renato Abrill

Quality Assurance Director, Lampire Biological Laboratories

“Our company was in a pinch to upgrade our ISO certification within a short timeframe.  80/20 Quality Consulting responded quickly and professionally.  They guided us through the process, while taking a hands on approach to actually helping us get the paperwork done.  They then provided an independent internal auditor because we didn’t have enough qualified people on our staff.  It wasn’t easy, but the proof was in the outcome – an upgraded certification with zero findings!  We will definitely have them help us with future work.  I can’t thank them enough.”

Mark Ensign

Executive Vice President, Cristcot

“80/20 Quality Consulting has helped our organization with our FDA/ISO compliance by taking the time to understand what we do and how we do it. Their customized approach has helped us meet ISO 13485 regulations while streamlining our SOPs.”

Mark Sutera

Senior Engineer, Surgical Tables