When it comes to records and document policies, procedures and controls, Cerulean goes beyond “best practices” to practicalities and realistic solutions. Our managing director spent his career putting in place records management departments, IT departments and ensuring compliance with 21 … Continue reading →
Despite all the media alerts and scare stories of executive emails coming back to haunt companies, records retention requirements are far more complicated and risky than simply emails taken out of context. Firms that do not understand the myriad of … Continue reading →
In today’s global landscape, last century’s compliance frameworks, work flows, and SOPs serve as an anchor dragging down traditional big pharma: Investor pressure is on for us to streamline our compliance activities and reduce overhead. And yet we still have … Continue reading →
Our expertise blends with our real-world experiences being responsible for balancing budgets, achieving compliance, and ensuring efficient operations: We’d received multiple 483s from an FDA inspection and lacked the resources to quickly solve the issues. Cerulean conducted a gap analysis, created … Continue reading →
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 needs and the agency’s worries, and gave us a quick turn-around time. He was instrumental … Continue reading →
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 from our work together were (1) learning how to prioritize and then accomplish the quality … Continue reading →
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. Applying the aspects of quality by design you taught us has cut months off our … Continue reading →
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 and controls you helped us build and put into place should be the model for … Continue reading →
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 market for the first time. Here’s what one CEO said: Cerulean was a true partner. … Continue reading →
A good audit is far more than a simple catalogue of gaps – more important is crafting recommendations for a business that fit their needs, with realistic solutions and long-term guidance: John truly shares his expertise and knowledge with you. … Continue reading →
