Areas of Expertise

• In-depth knowledge of FDA, ICH,TPD and TGA regulatory requirements
• Extensive experience with FDA pre-approval and TPD inspections
• Expertise in building and improving GMP quality systems and regulatory compliances
• Broad experience and knowledge in analytical techniques, method development/validation
  and testing requirements for the global market
• Troubleshooting and problem solving
• Strategic planning and Project management
• Training, Coaching , Mentoring