Facet’s strategic and tactical regulatory affairs, statistics, regulatory writing, and commercialization experts lead small organizations to faster and more efficient product development, US registration, and commercial launch.

Facet’s regulatory experts can help you decide if you are ready to meet with the FDA and/or submit the IND for your product.  Let us help you minimize risk and improve the probability of success in gaining agreement with FDA in your formal meetings and getting IND clearance.

Facet statisticians provide necessary and important expertise in FDA meetings to answer clinical trial design, methodology, sample size, power, and data interpretation questions.

A Market Understanding can help you establish the right niche for your product and help you to focus and streamline development.  Even if you are not planning to take your product to US approval, a robust Market Understanding adds value to your asset and helps you communicate your product’s value with potential acquirers/partners.