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Rescued from FDA Observations

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 a practical roadmap for resolution, and then helped lead our internal team to collaboratively drive the roadmap to success in 3 months. As a result, we landed two new multi-million dollar projects.”

– Regulatory Affairs & Quality Management Director, Pharmaceutical CMO, Boston, Massachusetts

For help on improving compliance’s bottom line impact, contact us today