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Can Compliance Help Marketing and Business Development? Cerulean Publishes its Latest Case Study
Williamsburg, VA
Thursday, October 23, 2008
The secret in many FDA-regulated businesses? Marketing and Business Development groups frustrate their colleagues in Quality Systems, Regulatory Affairs and Compliance…and vice versa.
Marketing's main beef: How are consumers – much less business partners and investors – supposed to learn about and get excited about a new product if our ideas are opposed at every step of the way by compliance, quality and regulatory?
Compliance's constant refrain: If we have no scientific proof, we cannot claim it, say it or even hint at it.
The end result: two business-critical departments at odds in a company whose bottom line suffers.
Cerulean's new case study suggests that there is a way to turn compliance from the millstone around marketing's neck the whetstone that helps hone a sharper competitive edge. HydroGel Burn Products shifted quality and regulatory affairs further upstream in the product development process to a point where everyone's focus had to be on finding a way around obstacles.
The results pleased investors, partners, customers and marketers alike.
As the CEO of HydroGel put it earlier this year, "After a few months, it became clear that the more traditional quality and regulatory folks who knew only quality and regulatory affairs had too difficult a time adjusting to the more proactive, solutions-focused outlook we needed"
After trying several different FDA quality and FDA compliance consulting companies, all of whom took traditional risk-averse approaches, HydroGel's executive team approached John Avellanet and Cerulean Associates.
Mr. Avellanet helped the HydroGel executive team put in place two strategies that netted positive results: the creation of a product concept document and the incorporation of marketing and business development discussions into quality systems and product design reviews.
To learn the details behind the tactics involved, get your copy of the case study today at the Cerulean Associates website.
If you are a journalist or editor and would like a private copy of the case study, please contact the author directly: john @ceruleanllc.com
John Avellanet is a frequent speaker and author on lean compliance (cost-effective regulatory compliance and FDA quality systems), quality by design, and preventing intellectual property theft. He shares the stage with FDA officials and in 2008, was one of the key speakers at the Contract Pharma & Outsourcing Conference in New Jersey, a keynote speaker at the PharmaQbD workshop out of Chicago, Illinois, a featured speaker at BIO 2008 in San Diego and the ICCA National Conference in Washington, D.C. He guest lectures at the College of William & Mary's top-ranked Mason Business School and Virginia Commonwealth University's Business School.
In 2006, Mr. Avellanet co-founded his independent executive advisory firm, Cerulean Associates LLC, and began publishing his monthly regulatory intelligence newsletter, SmarterCompliance™, the following year – now subscribed to by directors, vice presidents, CEOs and business owners around the world. Excerpts from Mr. Avellanet's articles and speeches are syndicated in biopharmaceutical and device journals in the U.S., Canada, Europe and India. People realize he knows what is going on in the compliance world.
Cerulean Associates LLC is a small, private compliance consulting company that helps executives implement lean compliance, quality by design and effective management oversight through its FDA coaching and advisory program, the SmarterCompliance™ Toolkit. On the web at www.ceruleanllc.com.
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Marketing's main beef: How are consumers – much less business partners and investors – supposed to learn about and get excited about a new product if our ideas are opposed at every step of the way by compliance, quality and regulatory?
Compliance's constant refrain: If we have no scientific proof, we cannot claim it, say it or even hint at it.
The end result: two business-critical departments at odds in a company whose bottom line suffers.
Cerulean's new case study suggests that there is a way to turn compliance from the millstone around marketing's neck the whetstone that helps hone a sharper competitive edge. HydroGel Burn Products shifted quality and regulatory affairs further upstream in the product development process to a point where everyone's focus had to be on finding a way around obstacles.
The results pleased investors, partners, customers and marketers alike.
As the CEO of HydroGel put it earlier this year, "After a few months, it became clear that the more traditional quality and regulatory folks who knew only quality and regulatory affairs had too difficult a time adjusting to the more proactive, solutions-focused outlook we needed"
After trying several different FDA quality and FDA compliance consulting companies, all of whom took traditional risk-averse approaches, HydroGel's executive team approached John Avellanet and Cerulean Associates.
Mr. Avellanet helped the HydroGel executive team put in place two strategies that netted positive results: the creation of a product concept document and the incorporation of marketing and business development discussions into quality systems and product design reviews.
To learn the details behind the tactics involved, get your copy of the case study today at the Cerulean Associates website.
If you are a journalist or editor and would like a private copy of the case study, please contact the author directly: john @ceruleanllc.com
John Avellanet is a frequent speaker and author on lean compliance (cost-effective regulatory compliance and FDA quality systems), quality by design, and preventing intellectual property theft. He shares the stage with FDA officials and in 2008, was one of the key speakers at the Contract Pharma & Outsourcing Conference in New Jersey, a keynote speaker at the PharmaQbD workshop out of Chicago, Illinois, a featured speaker at BIO 2008 in San Diego and the ICCA National Conference in Washington, D.C. He guest lectures at the College of William & Mary's top-ranked Mason Business School and Virginia Commonwealth University's Business School.
In 2006, Mr. Avellanet co-founded his independent executive advisory firm, Cerulean Associates LLC, and began publishing his monthly regulatory intelligence newsletter, SmarterCompliance™, the following year – now subscribed to by directors, vice presidents, CEOs and business owners around the world. Excerpts from Mr. Avellanet's articles and speeches are syndicated in biopharmaceutical and device journals in the U.S., Canada, Europe and India. People realize he knows what is going on in the compliance world.
Cerulean Associates LLC is a small, private compliance consulting company that helps executives implement lean compliance, quality by design and effective management oversight through its FDA coaching and advisory program, the SmarterCompliance™ Toolkit. On the web at www.ceruleanllc.com.
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John Avellanet
Managing Director
Cerulean Associates LLC
Williamsburg, VA
757-645-2864
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