We make extensive national databases and regulatory requirements to ensure we can follow the least burdensome path 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, revise, and compile the entire label that balances commercial interests and meets regulatory compliance. That the technological characteristics are comparable. Ensure that questions of safety or effectiveness differences are addressed adequately.
