SmarterCompliance Newsletter


The first newsletter exclusively devoted to FDA, ICH & IMDRF compliance and regulatory intelligence

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

Expert advice on

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 practicesPart 11 compliancerecords & document controlssupplier management … ICH, EMA and IMDRF rules.  You’ll always be one step ahead of regulatory developments.

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
  • FDA enforcement reviews with recommendations to keep you ahead of the investigator
  • Emerging FDA 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.

Free issues to preview

Subscriber benefits

  • One full year of the SmarterCompliance newsletter at a reduced rate
  • Subcribers-only access to the expanded online edition with supplementary reports, presentations, and internal documents from FDA, ICH, IMDRF, EMA and other regulatory health agencies (MHRA, Health Canada, etc.)
  • Exclusive year-end FDA forecast and planning issue with reliable advice on what will happen next for FDA compliance – and how you can take advantage
  • Regulatory documents and presentations from FDA, ICH, EMA, IMDRF and more
  • The latest outlook for quality system trends and best practices
  • Periodic email alerts on breaking compliance news with specific recommendations
  • More than 70 bonus downloads and checklists throughout each year to help you maximize results
  • Free FDA 483 reports
  • Best strategies to slash your risks
  • Tips to minimize compliance costs
  • Discounted savings off the regular newsstand price
  • Personal access to Cerulean’s managing director by phone or email for more guidance about anything you read in the SmarterCompliance newsletter


Regulatory and quality systems advice you can count on.”
– Carl Anderson, former FDA inspector

Prepare for the regulatory landscape ahead

Who should subscribe

  • Corporate executives & senior managers
  • CEOs and chief compliance officers
  • Regulatory affairs directors and VPs
  • Quality system directors and VPs
  • General counsels
  • Records managers and IT directors
  • R&D directors
  • Anyone with decision-making authority interested in cost-effective compliance

Risk-Free 100% Money-Back Guarantee

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.

Your key to better compliance & better quality

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

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

Turn FDA compliance into a competitive advantage

The SmarterCompliance newsletter is published six times a year in print and digital format.

Guest articles

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.