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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

Latest Article

Virtual Suppliers Cause Better Incoming Acceptance Inspections

August 6th, 2012

Drugmakers and medical device firms should expect at least 10% of their suppliers are “virtual companies,” often with only a single administrative office or just a post office box being their only tangible existence, said John Avellanet, founder and principal … Continue reading

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