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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.
"This should be mandatory reading for industry executives"
- Dan Michels, former FDA inspector
Latest Article
Virtual Suppliers Cause Better Incoming Acceptance Inspections
August 6th, 2012Drugmakers 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
Client Success Stories
“We'd received multiple 483s from an FDA inspection and lacked the resources to quickly solve the issues. Cerulean conducted a gap analysis, created a practical roadmap for resolution, and then helped lead our internal team to collaboratively drive the roadmap to success in 3 months. As a result, we landed two new multi-million dollar projects.”
- RA & Quality Management Director, Pharmaceutical CMO, Boston, Massachusetts
