eTMF Adoption and Integration Accelerating

Halloran Consulting Group CEO, Laurie Halloran, and principal consultant, Mark Vermette, were recently quoted in a feature in the December CenterWatch newsletter titled “eTMF Adoption and Integration Accelerating.”
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FDA reporting tool

Device manufacturers beware!  FDA recently released a reporting tool to supplement their compliance oversight resources.  Through FDA’s website, anyone can complete and submit a form to report allegations of regulatory misconduct.
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Understanding the 4 Types of FDA Inspections

If you are a manufacturer or a processor of FDA-regulated products, sooner or later, you can expect a visit from FDA. The purpose of this visit is to verify compliance with all relevant regulations — most commonly referred to as an “FDA inspection.”  But not all inspections are created equal.
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