XGene Regulatory Intelligence Platform
Connect enforcement signals to quality systems, services, expert commentary, and implementation resources.
FDA's new voluntary quality maturity pilot could eventually influence inspection frequency. Here's how mid-size manufacturers should decide whether to participate now.
FDA has cited laboratory controls as its most frequent drug manufacturing observation for fourteen consecutive years running. The problem isn’t that pharma companies don’t know the regulation. The problem is they keep misdiagnosing what the observation actually means. I’m Khaled Aamer, founder of XGene LLC, and I’ve written 483 responses across six sterile manufacturing remediations. […]
View details →Welcome to the XGene Regulatory Intelligence podcast. I’m Khaled Aamer, founder and principal consultant at XGene LLC. This episode walks through something that consistently separates sites that pass FDA inspections cleanly from sites that keep collecting preventable 483 observations: how they spend the 90 days before the investigator arrives. The companies that perform best in […]
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