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What Our Clients Say...

We are proud and honored by the compliments that we receive from clients of our specialized consulting services. Here are a few of them....

 

Lean Regulatory Affairs in a Mid-Sized Pharma Fast-Tracked from 9 to 6 Months

Cerulean designs and puts in place a flexible, cost-effective regulatory affairs structure to match complicated business and global compliance requirements in record time:

"John Avellanet's frequent speaking engagement requests from the industry is a reflection of his expertise and reputation.  In 2009, we got to see this first hand.  John helped us on a business-critical project expected to last 9 months.  Midway through, senior management challenged us to expedite the project by 3 months and we succeeded thanks to John's dedication to get the job done - and done right.  He found the time to help us fast-track the project although he was in the process of writing and finishing his new book.  If I had to pick three phrases to characterize John they'd be:  expert, on-time, and high integrity."

Anita Fauchier, Director, Atlanta, Georgia

 

FDA Compliant Records Retention for Less

Implementing a records management and retention program for FDA compliance is about blending records requirements with down-to-earth realities:

"John Avellanet was extremely helpful in assisting us to develop records and information management policies and records retention schedules that matched with FDA requirements and our resource capabilities.  In addition, he managed our project expectations well and kept us on track and on budget."

Chih-Wu Chang, Senior Manager, San Diego, California

 

Recommendations Exceed Expectations

A good advisor finds a way to deliver more value than promised, keeping the client's business success more in mind than the invoice:

"Slingshot commissioned Cerulean’s services to extend our knowledge of how our products could assist companies in the pharmaceutical industry.  John delivered against this objective and then some. John kept our objectives front of mind in every conversation and deliverable he made.  He also considered our objectives as a baseline, consistently delivering more than was documented and expected."

Gordon Russell, President, and Simon Elleway, Director, Dedham, Massachusetts

 

FDA Audit Focused on Client Success

A good audit is far more than a simple catalogue of gaps - more important is crafting recommendations for a business that fit their need, guiding realistic fixes and minimizing costs:

"John truly shares his expertise and knowledge with you.  During an audit we conducted last year, he regularly gave the client practical and unbiased recommendations, making sure the focus was always on their ability to succeed, not just comply."

Jackie Cassada, President, Charlottesville, Virginia

 

Medical Device Firm Sees Quick Results for Less

Our managing director really understands the needs of small and midsized businesses.  Here's what one Quality director said:

"John provides excellent advice that is both compliant and reasonable (meaning able to be achieved, something that for those of us with a small staff, is critical). He also works within the constraints of a current system and a company’s business realities when providing advice on adding new areas for compliance. This has helped integrate the systems into our company much faster and for a lot less than if other areas needed to be revised to accommodate. Again with a small staff and low budget, this has been extremely helpful. I would recommend John for small to mid-size firms that need to be in regulatory compliance with the FDA and want to get to market (or partnership) quickly."

Michael Weber, Director of QA, Williamsburg, Virginia

 

Medical Device Startup Gets to Market Fast with Great Service

We offer a unique "80/20" perspective in regard to quality systems and compliance.  You don't need perfect compliance, particularly if you are just trying to get to market for the first time.  Here's what one CEO said:

"Cerulean was a real partner.  John was instrumental in guiding the development of a FDA compliant quality system from ground zero in record time.  This was accomplished in an environment of limited resources and rapidly changing processes.  Through it all, he was a delight to work with and always brought more to the table than we were expecting.  We continue to utilize his talents to make sure we stay on track."

Thomas Kerry McCarter, CEO, Newport News, Virginia

 

Biotech and Device Company Passes FDA and DEA Audits Time and Time Again

"Five years later and, in my opinion, the strategies you helped us build and put into place should be the model for anyone needing to enhance productivity while dealing with regulatory compliance."

Timothy Beane, Vice President, Richmond, Virginia

 

Pharma R&D Speeds New Drug Development with Quality by Design Workshop

"Applying the aspects of Quality by Design to our projects, determining critical quality attributes at earlier stages and streamlining our downstream activities has cut months off our drug development cycles.  I continue to see lots of benefits.  You gave us an excellent structure to follow."

Thomas Horstmann, Senior Research Director, Boston, Massachusetts

 

Device Firm Puts in Place Practical, Cost-Effective Quality System

"John had the knowledge and real life experience to get our QA system up and running fast.  The two most important benefits from our work together were (1) learning how to prioritize and then accomplish in order of importance the quality and compliance issues necessary to ensure our survival in the event of an inspection by the FDA; and (2) seeing how to put in place practical, cost conscious solutions to our QA system gaps.  Your practical approaches are wonderful."

Allan Staley, President, Hampton, Virginia

 

Pharmaceutical Division Masters Data Integrity in a One Day Workshop

"I was very pleased with the results.  Beyond my expectations."

Jim Roberts, Director, Ridgefield, Connecticut

 

Product Development Group Implements Compliance Tailored to Them

"I have not encountered many people in this industry who share your pragmatic, methodology-agnostic, 'just do the right thing' approach.  Keep it up."

Gene Babinsky, Senior Product Director, Chicago, Illinois

 

University and Government Agency Get Fast Response and a Better Product

"Cerulean immediately understood our needs and the agency's needs, gave us quick turn-around time and was instrumental in creating a better product."

Madeline Snow, Director, Lowell, Massachusetts

 

Product Development Consulting Company Refers Its Clients to Cerulean

"Your managing director is the most user-friendly compliance person I have ever met.  He is so knowledgeable about this field that he is able to strip all the jargon off his discussion and can describe it in simple lay terminology.  I recommend him now to all my senior level executive colleagues.  As far as I'm concerned, John is the best in the business."

William Cope, President, Pine Island, Florida

 

Company Gets Great IT Compliance Advice in an Hour

"In the span of an hour phone call, you saved us more than $50,000 in unnecessary activities from another consultant.  Thank you so much."

Bernard Longo, Director, Hampton, Virginia

 

And more ...

"You bring a real walked-in-those shoes set of experiences.  I can't tell you how much that begins to make people feel comfortable right away."  - Mark Kessler, President, New York, New York

"Your advice helped us negotiate millions in funding.  Thank you."  - Kirsten Kellogg, Director, Williamsburg, Virginia

 

Are You Ready to Start Turning Your Compliance into a Competitive Edge?

Call our managing director at +1.757.645.2864 or email us at info[at]ceruleanllc.com to schedule a free, up to 30-minutes "no-sales-pitch" email or phone consultation.

Start turning FDA compliance into competitive advantage.