Know about PRE-IND MEETINGS

PDG’s team of industry professionals has extensive experience in planning Pre-IND Meetings on our clients’ behalf (as well as other Type B Meetings). This includes strategy, preparation, facilitation and post-meeting follow-up. Based on our experience, we believe that an effective Pre-IND Meeting is critical to a successful product development program. The Pre-IND Meeting is a strategic and relatively low-cost early determinant of the critical path for your product’s development. Such meetings are particularly valuable in the absence of sponsor experience, guidance or other FDA information and standards. Regardless, the Pre-IND Meeting will help identify and resolve early development issues encountered specifically in the areas of toxicology, pharmacology and formulation/CMC.

Meeting with FDA staff contributes to prevention of clinical holds and provides useful information in the compilation and submission of an IND. In short, strategically planned and professionally facilitated Pre-IND Meetings increase the chances for success of your development program. Despite the availability of guidance meant to assist sponsors, FDA meetings can be intimidating and unproductive. As such, many sponsors fail to get the most benefit from them. Engaging a consultant such as PDG who routinely and successfully orchestrates Pre-IND meetings will help you avoid costly delays, build a solid relationship with FDA, and secure FDA’s early opinions and buy-in on your project.

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