freije quality engineering, llc


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freije quality engineering, LLc
verified veteran owned business



who we are



We are a full-service consulting firm providing clients with quality system and regulatory affairs consulting. Our goal is to make your life easier and your day-to-day operations more efficient



proactive supplier management



Proactive supplier management is a transformational change in your current supplier management program.


Proactive supplier management is carried out through a series of step changes.


Supplier management is accomplished strategically as opposed to the typical traditional approach.



Compliance Assessment



Freije Quality Engineering can assess your company’s adherence to FDA and ISO requirements.


We can evaluate your procedures, processes, and records to generate a detailed gap analysis identifying your strengths and weaknesses.


After conducting the gap analysis your company will receive cost-effective recommendations customized to the need of your company.


We do not believe in the one size fits all mentality.



Warning Letter Remediation



We agree this is not a pretty situation you wish to find your company in, but if you have the misfortune of receiving an FDA Warning Letter, let our experienced professionals guide you through the remediation process.


Our experienced professionals will develop remediation plans in response to FDA Warning Letters, unfavorable ISO audits and 483’s.


Our professionals can assist your organization in the resolution of FDA and ISO violations by working with you to develop and implement effective corrective actions as well as implementing preventive actions.



contact information


email: info@freijequalityengineering.com