Douglass Oeller Consulting, Inc.

Helping clients understand and comply with the law, regulations, guidelines, policies, and procedures by which the US Food and Drug Administration Center for Veterinary Medicine regulates new animal drug products

Services

  • Determining the regulatory category for animal health products
    • Drug
    • Biologic
    • Device
    • Other
  • Strategic planning for animal drug development
    • Regulatory requirements
    • Schedule and time requirements
    • Cost estimates
  • Establishing INAD files
  • Organizing meetings and negotiating with FDA
  • Monitoring for GLP and GCP studies
  • Drafting and editing documents for FDA review
    • Target Animal Safety and Efficacy protocols
    • Final Study Reports
    • Adverse Drug Experience evaluation and summaries
    • Labeling
    • Freedom of Information summaries
    • All Other Information reports
    • Categorical Exclusion requests
    • New Animal Drug Applications
    • Suitability Petitions
    • Abbreviated (Generic) New Animal Drug Applications
  • Preparation of Technical Sections for INAD Phased Review
  • Electronic submissions using the FDA ESG
    • Drug listing and registration
    • Drug shipment notices (NCIE)
    • Meeting requests
    • Protocol review requests
    • Notice of final disposition
    • Notice of intent to slaughter
  • US Agent for foreign companies
  • Gap analysis for products currently marketed in other countries
  • Expert witness services