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Full of expert compliance advice, and actionable practical quality systems insights for biotechnology, pharmaceutical, and medical device executives. Subscribe today.
This should be mandatory reading for a lot of executives in the industry.”
- Dan Michels, former FDA investigator
Expert advice on
- FDA quality systems
- ICH, EMA, ISO & IMDRF guidelines
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- FDA enforcement trends
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- Part 11 & Annex 11 strategies
SmarterCompliance is part of Cerulean’s SmarterCompliance Toolkit. Designed to help you meet evolving FDA requirements with in-depth, expert analysis and advice. With SmarterCompliance, you can make the best informed decisions.
Get practical advice and real-world 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 … GCP compliance … ICH, EMA and IMDRF rules. With SmarterCompliance, your compliance is always one step ahead of regulatory inspectors.
Membership and subscriptions to SmarterCompliance are based on the calendar year.
FDA expert advice for the best decisions
- Concise strategies to balance business & compliance
- Case studies and practical “how to” articles
- Tips from former FDA officials & industry experts
- New regulatory guidance analysis and walk-through
- FDA enforcement reviews with recommendations to keep you ahead of the investigator
- Emerging FDA enforcement expectations
- Highlights of the impact of new legislation, regulations, and guidelines
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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- One full year of the SmarterCompliance newsletter
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Regulatory and quality systems advice you can count on.”
- Carl Anderson, former FDA investigator
Prepare for the regulatory landscape ahead and subscribe today
Who should join
- Corporate executives & senior managers
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- Anyone with decision-making authority interested in cost-effective compliance
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See what readers say
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
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
Turn compliance to a competitive advantage and subscribe today
The SmarterCompliance newsletter is published six times a year in print and digital format. Subscriptions are based on the calendar year.
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.