Home  |  Success Stories  |  Advising  |  Newsletter  |  Speaking  |  Articles  |  Seminars  |  Reports  |  Services  |  About Us  |  Contact Us    

Home Client Results SmarterCompliance Program Compliance Newsletter Speaking & Workshops Articles & Case Studies Seminars & Resource Kits Industry Reports & Links Specialized Consulting Services About Cerulean Contact Info

SmarterCompliance™ Newsletter

FDA Intelligence and Expert Quality Systems Advice

The first newsletter exclusively devoted to FDA compliance best practices, quality system advice, actionable regulatory intelligence, and cutting-edge product development strategies for biotechnology, pharmaceutical, and medical device executives.

   "A Unique and Well-Needed Voice on the Industry"
- M. Stawicki, Director, Regulatory Affairs, AstraZeneca

If you need independent expert analysis and advice you can trust to help you make the right decisions quickly, steer through change, and adapt to the evolving marketplace and regulatory landscape, then you need smarter compliance.

If you're looking for our independent FDA mock audit service or our FDA records retention advice, visit the specialized consulting services area of our website.

The SmarterCompliance newsletter is written to help you save money, limit risk, boost productivity, and improve the effectiveness of your FDA compliance and quality management systems while helping you speed time to market.  If you're looking to develop a regulatory radar and a compliance intelligence program to better plan for regulatory impacts to your new drug, biologic, or device development efforts, SmarterCompliance is the one newsletter you need.

Free Issue #1  (PDF)   |   Free Issue #2  (PDF)

If you do not know the regulatory and quality landscape ahead, you cannot gain advantage.

Each month you receive the latest insights and advice on what's working and what's ahead for pharmaceutical compliance ... device compliance ... quality systems ... avoiding FDA enforcement ... biotech compliance ... records and document controls ... FDA data integrity tips ... IT compliance ... GLP compliance ... GCP compliance ... Quality by Design ... PAT ... cGMP compliance ... QSR compliance ... new FDA expectations, and more - long before you see them elsewhere.

Check out the complete library of the past three years >>

 

 

Your new medicine development process can last 10 years or more - can you really afford not to plan for regulatory changes?

 

Get the latest FDA expert insights for the best decisions

• Concise strategies to balance business, quality and compliance
• Case studies and practical "how to" articles
• Actionable recommendations from FDA 483 and warning letter analyses
• GLP tips, GCP tips, GMP tips, GHTF tips, and ICH tips
• Trend analyses
• New regulatory guidance analyses
• An "ask the expert" section
• FDA enforcement analyses with recommendations to avoid trouble
• Featured reading
• Calendar of events

If you want to know what's ahead, if you want to make better decisions - whether you're dealing with pharmaceutical regulations, biotech regulations, FDA regulations, GCP regulations, GLP regulations, ICH rules, GHTF rules, and IT compliance - or you want to make regulatory compliance and FDA quality systems cost-effective - then you want smart compliance.

"A perfect blend of reliable advice and expert analysis. You really show how Quality Systems and Regulatory Affairs teams can play a better strategic business role."
  - S. Upadrashta, Vice-President, Regulatory Affairs & Quality, Aradigm

 

 

Your key to better compliance, better quality and better profit!

Subscribers get exclusive access to the full SmarterCompliance™ library of past issues, periodic compliance updates and specific "steps to take now" recommendations, plus information to contact the editor for private answers to your questions and much more - all at no extra cost.  That's one full year of GLP tips, GCP tips, GMP tips, QSR tips, FDA compliance tips, GHTF advice and ICH tips ... PLUS years of previously published newsletter articles PLUS compliance alerts with recommendations - perfect for staying off FDA's radar screen and getting your new medicines approved.

Free Issue #1  (PDF)   |   Free Issue #2  (PDF)

Subscribing to SMARTERCOMPLIANCE™ (ISSN: 1937-0776) is easy: purchase a subscription online or contact us if you prefer to pay via check or purchase order.  A subscription is $399 (USD) per year for 12 issues in the United States.  Outside the United States, subscriptions are $439 (USD).  Payment must be drawn upon a US bank account.  If you want to "try before you buy," contact us to request a trial subscription.

See the full list of SmarterCompliance subscriber benefits >>

 

Risk-Free 100% Money-Back Guarantee

And, if that wasn't enough to convince you of the incredible value of this monthly newsletter, we offer a risk-free, 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 are yours to keep, with no further commitment.  Read all the details of our no hassle cancellation policy.

 

Who Should Subscribe

• Corporate executives & senior managers
• CEOs and Chief Compliance Officers
• Regulatory affairs managers, directors and VPs
• Quality system managers, directors and VPs
• General counsels
• Records managers and professionals
• R&D directors
• Anyone with decision-making authority and interests in faster drug, biologic or device time to market, simpler quality and compliance processes, and avoiding FDA enforcement actions

 

 

The SmarterCompliance newsletter is written by FDA regulatory expert, John Avellanet, with contributions from other experts in the field and officials from the FDA.  The newsletter does not regurgitate news but gives you expert advice, tips, techniques, and strategies from someone who's been there, done that.  SmarterCompliance is the equivalent of getting insight and help from an expert FDA consultant for twelve months for less than $500 and a risk-free guarantee.  You will not find a better deal anywhere in the world.

"Your newsletter has continued to add lots of value to my thoughts in regulatory and compliance understanding."
  - A. Agarwal, Director, Quality, Torrent Pharmaceuticals

The newsletter is available toward the end of each month in print and electronic format.  Articles and briefings in the newsletter draw on a variety of sources, including published reports, interviews, FDA officials and ex-officials, and research.

 

Each newsletter has eight sections:

1. Strategic Analysis - timely marketplace and compliance topics impacting your bottom line

2. Tactical "How To" - a longer, more in-depth step-by-step set of advice for one aspect of a good compliance, quality or intellectual property security system

3. Enforcement Analysis - review of recent FDA enforcement trends such as 483s, warning letters, and steps you should take to protect yourself

4. Trend Watch - a regulatory marketplace analysis with specific recommendations to adapt to changing conditions

5. Ask the Expert - our managing director answers anonymous questions (send yours to smartercompliance[at]ceruleanllc.com)

6. Leadership Tactics - executive peer-level tips to improve your personal effectiveness

7. Book of the Month - a highlight of books with relevance to leadership, compliance and quality systems strategies, and business competitiveness

8. Bonus Downloads - complimentary downloads such as checklists, sample policies or SOPs, recent reports, additional articles, book chapters, and so on.

Newsletters average 8-12 pages in length plus full subscribers receive bonus downloads, expanded online content and articles, and periodic compliance alerts with specific recommendations to stay ahead of the competition and the regulators.  Download a sample compliance alert  (PDF)

To see the SmarterCompliance newsletter library and a complete listing of all topics, click here.

 

 

Guest Articles

We welcome guest article proposals.  Finished articles must be approximately 800 - 1,500 words; we reserve the right to edit for final content.  All submitted articles become the property and copyright of Cerulean Associates LLC and are subject to our terms and conditions.  Send proposals to:  Editor, SmarterCompliance™, c/o Cerulean Associates LLC, PO Box 498, Williamsburg, VA 23187-0498  USA.

 

Still Not Sure Cerulean's SmarterCompliance™ Newsletter will Help You Turn Compliance and FDA Quality Systems into Competitive Advantages?

Check out the proof and testimonials or learn more about our FDA SmarterCompliance™ Toolkit advisory program for executives and senior managers.

Join our mailing list today to keep up to date with new publications and compliance events.