Pharmanet

Client:	Large medical device company that acquired and invested significant resources in a first-of-a-kind, drug-eluting stent technology.

Challenge:	The company had limited experience with drug-delivery systems, drug testing, drug development, drug regulations, and CDER interactions. An additional challenge was that quality-control procedures for combination products may be subject to both cGMP and QS regulations, which are not identical.

Outcome:	PharmaNet assembled a multidisciplinary team of regulatory consultants intimately familiar with FDA regulation of combination products including drug-eluting stents. The team assisted in developing the entire CMC program for the stent, including all analytic methods, kinetic drug-release testing, stability testing, and quality control methods. With assistance from PharmaNet's regulatory consultants, the client developed an appropriately conservative approach to product development and testing that satisfied both the pre-market and compliance FDA review teams. The FDA approved the product, and the client successfully launched it.