NDA Partners LLC: A Development Partner to Biopharmaceutical Investors and Companies

Sandra Shire, DMD, MPA

Practice Area Focus

  • Medical Devices
  • Clinical Research
  • Inspection Readiness
  • Compliance
  • FDA Correspondence
  • Dental Products

Biography

Sandra Shire joined NDA Partners in 2012. Dr. Shire has had a wide and varied career in clinical practice, regulatory affairs, and academia. She developed a new Master’s program in Regulatory Science at Arizona State University, partnering with the US Food and Drug Administration CDER Academic Collaboration Program. Her FDA experience includes service as a Senior Regulatory Specialist with the Food and Drug Administration’s Office of Regulatory Affairs (ORA) and Scientific Reviewer, Division of Dental, Infection Control and General Hospital Devices, Center for Devices and Radiological Health, (CDRH). Sandra has lectured extensively as an invited speaker on clinical trials and FDA audits.