Drug Development Strategies and Assessments and IND Review
The decision to bring a compound into development is serious and should not be taken lightly. It means making a critical evaluation of not only the science, medicine and commercial information, but also the changing regulatory requirements and environment that you will be operating within. A wrong decision can be very costly for your company. Too conservative a view, and you could be abandoning a promising candidate. With an overly optimistic view of the information, you could be committing time and money unnecessarily. Dr. Kennedy can bring his 25 years of regulatory experience to assist you in making this important decision.
Are you preparing an NDA for submission? Dr. Kennedy can provide an independent review of your NDA to help reduce surprises at the end and/or to get bad news early enough to do something about it without jeopardizing your time line.
Due Diligence associated with company or product acquisition
Product acquisition is becoming important to more companies now than in the past. Technological breakthroughs and new science challenge the regulatory frontiers. If you are considering a product or company acquisition, Dr. Kennedy can bring his experience to assist you in determining the regulatory viability of such an acquisition.
There have been significant changes in the technology associated with electronic submissions. Concurrent with these changes, are significant changes in the expectations of FDA. Beginning in October 2002, as per the provisions of FDAMA, the FDA is required to be in a position to accept any and all submissions in an electronic format.
Dr. Kennedy can help you develop your electronic submission strategy if you have not already done so, or he can review your existing strategy for currency.
FDA Meeting Preparation
Whether you are preparing for a pre-IND, End of Phase II, Pre-NDA or Advisory Committee meeting, Dr. Kennedy can help you plan for and conduct these critical interactions with FDA. This service is intended to maximize the performance of your company and your staff, not replace it.
There is no secret recipe for a successful FDA meeting, and Dr. Kennedy does not use a single model or approach. His experience will lead to an optimal approach to achieve your meeting objectives. The difference between successful and unsuccessful meetings is often the quality of the planning for these meetings.