Challenge: A venture-funded European biotechnology company needed a regulatory strategy for a combination device-biological CNS product.

Beaufort Solution: The company’s product had demonstrated significant promise based on animal and theoretical models. However, it needed guidance in getting to the first stage of the IND/IDE process. The company engaged Beaufort to support this development. Beaufort worked with management to assess existing and potential competitive products and to determine which of the potential indications should prove most valuable. Our work included a regulatory strategy for optimally approaching the IND/IDE stage of product development with the result that the client now has a detailed plan with a streamlined set of possible indications.

Date posted: September 9, 2011

Categories: Case Studies Regulatory Affairs