KKB's advice covers all aspects of drug research and approval, including:

• Licensing and related issues for:
  • Investigational New Drug Applications (INDs)
  • New Drug Applications (NDAs)
  • Abbreviated New Drug Applications (ANDAs)
  • Biologics License Applications (BLAs)
  • Amendments and supplements to applications
• Compliance with post-approval requirements for changes in products, labeling and manufacturing processes
• Interpretation and application of FDA current good manufacturing practice (cGMP) requirements
• Establishment registration and product listing
• Establishment, application, and product user fees
• FDA reporting requirements
• Orphan drugs and pediatric drugs
• Controlled Substances
• HIPAA and Privacy Issues