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Client Newsletter

The first newsletter exclusively devoted to FDA, ICH and IMDRF compliance best practices, quality system advice, actionable regulatory intelligence, and cutting-edge product development strategies for biotechnology, pharmaceutical, and medical device executives.

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- Dan Michels, former FDA inspector

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Latest Article

FDA Inspection Handling – 10 FAQs & Tips

January 10, 2014

FDA inspections are stressful and worrisome.  Failed FDA inspection costs include sales revenue loss, stock price decline, and public embarrassment from FDA warning letters and FDA-483 observations.  Every so often …  Continue reading at ComplianceZen.com →

Client success stories

John Avellanet was extremely helpful in assisting us to develop records and information management policies and records retention schedules that matched our FDA requirements and our resource capabilities. In addition, he managed our project expectations well and kept us on track and on budget.

- Chih-Wu Chang, Senior Quality Manager, San Diego, California

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