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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.

Who we work with