Helping innovative companies overcome regulatory barriers
We leverage decades of experience to demystify IVD regulatory requirements, bridging the gap between our clients and the FDA.
What we do
We Know IVD Regulation from the Inside Out
With over three decades’ combined experience in the regulation of diagnostics at the FDA, we know what regulatory bodies are looking for.
With two decades of IVD industry and clinical lab experience, we understand the real-world issues that IVD manufacturers and end-users face.
We Know IVD Regulation from the Outside In
Who we are
We offer review, feedback, and training to increase the likelihood of a new product’s regulatory success.
We advise on a product’s likelihood of regulatory success and a manufacturer's regulatory readiness.
We provide guidance in the development of regulatory systems and training to strengthen regulatory efforts.