We first review and make an assessment to exclude that the product does not predicate or a possible reference product available legally in the market. After which we ensure the least burdensome regulatory requirements for marketing the product.
We assist with appropriate wording on the product labels. Ensuring that “intended use” and “indications for use,” are appropriate for the product. We review and discuss the contents related to the technological characteristics of the product and ensure that adequate data has been generated to address questions related to safety or effectiveness.
If there are gaps in data, we provide appropriate guidance and any additional studies that need to be conducted to meet the product’s claims and specifications.
