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

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