FDA Regulatory Clearance and Approval

At EBG Advisors, we support clients through both the Food and Drug Administration (FDA) clearance and remediation process and other federal and state agency requirements. Utilizing our vast experience in this area, we can help expedite and guide our clients successfully through the regulatory quagmire and assist drug and medical device manufacturers in bringing new products and innovations to market quickly and efficiently.

We know that a successful process requires many other facets, from figuring out the best way to collect the scientific and clinical evidence needed by regulators to building an appropriate health economics case for reimbursement. Accordingly, our services cover the following:

  • Early product development and the investigational phases
  • FDA regulatory clearance and approval
  • Quality system remediation
  • Business planning and reimbursement
  • Post-approval compliance and enforcement
  • Regulatory opportunities and other issues