Whether you need help quickly responding to an FDA inspection or turning around a failing project, Cerulean can help. “Cerulean’s managing director immediately understood our

“Cerulean’s John Avellanet had the knowledge and the real life experience to get our QA system up and running fast.  The two most important benefits

Our managing director has been involved in quality by design since the 1990s when the FDA and the pharma industry were just exploring the concepts.

Ensuring compliance is not a hindrance to productivity requires understanding product development, commercialization, and regulatory compliance: Five years later and, in my opinion, the strategies

We offer a unique “80/20” perspective in regard to quality systems and compliance.  You don’t need perfect compliance when you are trying to get to

A good audit is far more than a simple catalogue of gaps – more important is crafting recommendations for a business that fit their needs,

A good advisor finds ways to deliver more value than promised, keeping the client’s business success more in mind than the invoice: :We commissioned Cerulean’s

For a mid-sized pharmaceutical company, we designed and put in place a flexible, cost-effective regulatory affairs framework to match a complicated business environment with global

Understanding the needs of small and mid-sized businesses is critical; far too many consultants suggest fixes that will never work in a fast-paced, growing company:

Cerulean assisted a mid-sized pharmaceutical firm to design and implement lean FDA compliant records retention: “Cerulean’s John Avellanet was extremely helpful in assisting us to