FDA HEADING IMAGE
  1. Regulatory Affairs Strategy Development
  2. FDA Submissions:
    • Investigational New Drug Applications (INDs)
    • New Drug Applications (NDAs)
    • 510(k)s
    • Investigational Device Exemptions (IDEs)
    • Pre-Market Approval (PMA)
  3. Analyte Specific Reagent (ASR) Regulatory Compliance
  4. FDA Registered U.S. Agent for Foreign Manufacturers
  5. Training Programs/Seminars/Distance Education
  6. Clinical Trial Management/Documentation
  7. Continuing Medical Education (CME) content development
  8. CPT Coding, Diagnostic Reimbursement issues
  9. Due Diligence
  10. HIPAA & CFR 21 Part 11 Compliance
  11. Quality Systems Compliance (QSRs, QA/QC, GMPs, SOPs)
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