Client Success Stories

FDA Part 11, Pre-Approval Inspections and Clinical Data Integrity

Getting ready to submit a new medicine or product for FDA approval is a hectic, anxious time. Worry that FDA will raise questions about data integrity and Part 11 only adds to the stress. Amid it all, day-to-day business must … Continue reading →

FDA Warning Letter Rescue

A mid-sized medical device manufacturer received an FDA warning letter. Cerulean was contacted over other consulting firms for several reasons, in the words of their president: First, Cerulean’s experience in dealing with our specific issues of quality management. Second, Cerulean’s … Continue reading →

Learn to Balance Compliance with Competitiveness

A small business supplier to the pharmaceutical and medical device industry was getting overwhelmed with demands that they be compliant with ISO, with cGMPs, and with 21 CFR 11. We defined a defensible strategy for compliance using ISO and elements … Continue reading →

Develop a Workable, Livable Quality System

Clinical research organizations that work with very vulnerable patient populations have to maintain the strictest confidentiality while ensuring FDA compliance and sponsor support. For one CRO based in Califorinia, they originally hired us to perform a mock FDA audit and … Continue reading →

Simplify Processes to be More Compliant

Suppliers to pharmaceutical and medical device companies have to strike a balance between compliance for some customers while satisfying all the rest. It leads to complicated workflows and inconsistent control. What if you could streamline your processes and improve compliance? … Continue reading →

Top-Notch, Practical Solutions

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 →

Reduce Records Risks

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 →

Harmonize & Streamline Compliance

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 →

Rescued from FDA Observations

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 →

Get Fast Response and Rescue an Off-Track Project

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 →