Regulatory & Reimbursement Core

Our Regulatory Core provides extensive regulatory, reimbursement, and quality assurance capabilities. On-site expertise is provided by PDC Clinical-Regulatory Engineer Alex Balus, who assists innovators with FDA inquiries and submissions and provides up-to-date advising on FDA guidances and initiatives, such as the use of real-world evidence in FDA regulatory filings. In addition, the PDC works closely with the UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI) to provide education opportunities for pediatric device innovators.

Advisors:

  • Michael Billig - CEO, Experien Group LLC - website
  • Linda Braddon, PhD - CEO, Secure BioMed Evaluations - website
  • Thomas Lawson, PhD - Principal Consultant, Lawson & Associates
  • Susan Rowinski, MSE - President & Founder, Rowinski Group LLC - website