Academic CRO Strengthens Compliance

Toward the end of a long winter, an internationally renowned academic clinical institution based in Philadelphia, Pennsylvania, chose Cerulean Associates LLC to provide a full

Rapid FDA Recordkeeping

FDA is citing firms more and more for inadequate recordkeeping and record retention. From electronic recordkeeping systems to all paper to a hybrid reality, firms

Data Integrity Training

FDA’s emphasis on data integrity and electronic record compliance causes anxiety, confusion and frustration. What is “data integrity” as it relates to day-to-day activities? to

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

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

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

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

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

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

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