Pre-IND Meetings with FDA
Gerald Yakatan, Ph.D., Founder, Chairman & CEO of IRISYS, has decades of pharmaceutical development, clinical trial strategy and design, and regulatory affairs experience. He interacts with high-level FDA personnel and has planned and engaged in numerous FDA pre-IND meetings with U.S. and foreign clients.
Dr. Yakatan leads a management team that has a deep understanding of current regulatory philosophy and standards. We have experience working directly with the FDA at all levels. IRISYS’ history of successful FDA IND guidance and drug development spans a wide range of therapeutic categories including anti-viral, neurology, oncology, gastroenterology, and OTC products.
Pre-IND (Investigational New Drug application) FDA meeting package & presentation preparation
IRISYS will:
- Meet with you to prepare for an FDA pre-IND Meeting
- Prepare a Briefing Book that includes a rationale for recommended clinical studies and other FDA pre-IND Meeting guidance
- Prepare your FDA Pre-IND Meeting presentation
- Accompany you to the FDA Pre-IND Meeting
- Give your company presentation at the meeting
- Review the FDA pre-IND feedback and provide strategic advice for advancing your product
