Tap~Root consultants have the scientific expertise to perform internal audits on functional foods and dietary supplements, audit support, as well as claims defense. We can also prepare your defense for FDA warning letters.
Regulatory Audit (Internal)
Is your product platform sound?
For those early in the design process or far along alike, review of product story, messaging points, and labels for strength, accuracy, regulatory compliance, and consistency.
Response to FDA Warning Letters
Let a science-and-regulatory-expert-in-one prepare your response documents
Prepare substantiation defending claims in response to FDA warning letters. We can work within the tight deadlines often involved. We have also worked with the lawyers involved in this process.