Challenge: A company that offers comprehensive contract manufacturing services required regulatory support.

Beaufort Solution: The company needed a clear regulatory strategy for bringing its project to market in the shortest possible time frame.  In addition, the client needed clinical trial management and data entry to support a 510(k) submission to the FDA.  Beaufort provided ongoing regulatory consultation and conducted the clinical trials, including site identification/qualification, clinical study and regulatory document preparation, IRB submissions, site monitoring and data entry in support of the company’s first 510(k) submission to the FDA.

Date posted: October 27, 2011

Categories: Case Studies Clinical Research Regulatory Affairs