GxP Auditing

Expert Quality Assurance consulting and auditing services for GMP, GCP, GLP, and PV quality systems.



We will take you all the way through to compliance following a high quality compliance audit.


Expert Witness

Choose from our selection of former FDA & industry experts to find qualified expert witnesses for your case.

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Laboratory Developed Tests: Issues and Anticipated Regulations


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3 FDA Warning Letter Trends for 2016

It’s one of the top questions asked of FDA consultants: What are the most common issues cited in warning letters and FDA Form 483 observations? Unfortunately for...Continue Reading

The Quick Guide to FDA Part 11 Compliance

Keeping sensitive data and information private and secure is as important to pharmaceutical and device manufacturers as it is difficult. Companies are increasingly digitizing information about their...Continue Reading

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