RAPS Fellows

Ronald Schoengold is a certified RAPS Fellow, recognizing senior regulatory professionals for their significant contributions and leadership in advancing the regulatory profession and the Regulatory Affairs Professionals Society (RAPS).

Quality & Regulatory

Ronald Schoengold has quality and regulatory expertise in:

  • 21CFR 820 QMS Audits (Medical Devices)
  • ISO 9001 Audits
  • GCP Audits (Clinical Trials)
  • cGMP Audits (Pharmaceuticals)
  • Consent Decrees
  • Warning Letters
  • FDA 483 Remediation
  • FDA Company Registration and Product Listing
  • 510(k) Submissions
  • 513(f) (2) De Novo Submissions
  • 513(g) Orphan Drug Applications
  • PMAs
  • Training Experience (Webinars and Work Assignments)
    • Risk Analysis
    • Root Cause Analysis
    • Risk Management for Medical Devices
    • Quality Planning: Process and Procedure
    • Internal Quality Audit
    • Root Cause Analysis for CAPA
    • Good Clinical Practice

Research & Development

Ronald Schoengold has R&D expertise with:

  • Rapid, Point-of-Care Diagnostic Devices
    • Gastroenterology (e.g., colorectal cancer, fecal occult blood (guaiac and FIT), H. pylori, Calprotectin)
    • Infectious Disease (e.g., Strep A, Gonorrhea, Chlamydia, UTI)
  • ┬áDiagnostic Systems
    • Clinical Chemistry (e.g., hCG, Na/K, glucose, BUN)
    • Hematology
    • Coagulation
  • Vaccine Development (e.g., Rubella, bacterial vaccines)
  • Pharmaceutical Product Development (antibiotics and antiviral drugs)
  • Cancer Markers
    • Colorectal Caner
    • Gastric Cancer
    • Prostate Cancer