Full of expert compliance advice, actionable regulatory intelligence, and real-world quality systems insights for biotechnology, pharmaceutical, and medical device executives.
This should be mandatory reading for a lot of executives in the industry.”
– Dan Michels, former FDA investigator
SmarterCompliance is written to help you meet evolving FDA requirements, bringing you in-depth analysis and advice on new FDA rules and guidance. With SmarterCompliance, you can make the best informed decisions.
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We cut through the clutter, put our recommendations up front and give you advice you can trust. Regular industry publications look backward. SmarterCompliance looks ahead, anticipating what’s next: a turn in FDA enforcement, a shift in global harmonization, device regulation convergence, and other key trends. See what readers and former FDA officials say.
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– Carl Anderson, former FDA inspector
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Written for Cerulean’s consulting clients & individual subscribers, each SmarterCompliance newsletter is designed to help you reduce risk, boost productivity, and improve the effectiveness of your quality systems and compliance activities.
A perfect blend of reliable advice and expert analysis. Your newsletter really shows how quality and regulatory affairs teams can play a better strategic business role.”
– S. Upadrashta, Vice-President, Regulatory Affairs & Quality, California
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– M. Stawicki, Director, Regulatory Affairs, UK
Incredibly well-written and well worth it.”
– T. Winchell, former FDA investigator, Kansas
Should be mandatory reading for a lot of executives in the industry.”
– D. Michels, former FDA investigator, Maryland
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Your newsletter continues to add lots of value to my thoughts in regulatory and compliance understanding.”
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Tells you exactly what you need to know – and how to stay one step ahead. It has helped so much.”
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Full of great real-world examples and tips.”
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Like getting an expert FDA consultant’s advice all throughout the year.”
– M. Weber, Director, R&D, Virginia
Expert quality systems advice you can count on.”
– C. Anderson, former FDA investigator, Washington
The SmarterCompliance newsletter is published six times a year in print and digital format.
We welcome guest article proposals and suggestions for interviews. Finished articles must be approximately 1,200-2,000 words; we reserve the right to edit for final content. Contact us directly or send proposals to: Editor, SmarterCompliance newsletter, c/o Cerulean Associates LLC, PO Box 498, Williamsburg, VA 23187-0498 USA.