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.
Get objective advice and the latest insights on what’s working & what’s ahead for the FDA … for GMP compliance … QSR compliance … FDA inspections and best practices … Part 11 compliance … records & document controls … supplier management … ICH, EMA and IMDRF rules. You’ll always be one step ahead of regulatory developments.
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.
Regulatory and quality systems advice you can count on.”
- Carl Anderson, former FDA inspector
If you are not 100% satisfied, you may cancel at any time during your active subscription and request a 100% refund of the price you paid for your current subscription term. All issues and bonus downloads are yours to keep, with no further commitment. The newsletter accepts no paid advertisements so every issue is entirely focused on delivering value to the reader.
If you’d like to “try before you buy,” contact us to request a free trial subscription.
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
SmarterCompliance is a unique and well-needed voice on the industry.”
- 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
I would like to compliment you on the style and content of your articles. To see brilliant, concise and clearly written articles is really refreshing.”
- P. Kildare, PDQA, Computer System Validation, Ireland
Your newsletter continues to add lots of value to my thoughts in regulatory and compliance understanding.”
- A. Agarwal, Director, Quality, India
Tells you exactly what you need to know – and how to stay one step ahead. It has helped so much.”
- A. Fauchier, Director, Regulatory Affairs & Quality, Georgia
Full of great real-world examples and tips.”
- C. Pillar, Director, Quality, Illinois
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.