FDA Meeting Strategy and Execution

You should leave a meeting with the Food and Drug Administration (FDA) with answers to critical questions and an understanding of the FDA’s expectations. To the best extent possible, any meeting with the FDA should end in clarity, and whoever is working on your project must ensure this happens.

To achieve your goals in an FDA meeting, the interaction must be carefully planned and flawlessly executed, leaving the FDA with a good impression of your product and company. This requires expert guidance from professionals who have prior regulatory experience and know the appropriate time to request a meeting, what is needed to prepare the necessary paperwork, what to expect when meeting with the FDA, and what steps should be taken post-meeting.

As frequent advocates for companies before the FDA, ProPharma Group takes your product and combines our knowledge of science, medicine, ethics, and regulations to prepare for each FDA meeting. We will guide you step-by-step through FDA meetings during each phase of the development process, including:

Pre-IND Meeting Planning

You have been planning for this moment for so long, and it is finally here. You’re ready to begin testing your drug in humans but are not sure that the design of your studies is valid, or maybe you’re looking for confirmation that your rationale is sound. You need to attend a Pre-IND Meeting with the FDA. The Pre-IND Meeting will allow you to communicate with the FDA early in the process, getting feedback on your drug development program before moving forward.

ProPharma Group: Pre-IND Meeting Experts

ProPharma Group will guide you through the entire Pre-IND process – from submitting the initial FDA meeting request and supporting briefing document through preparing for and executing the meeting. Our goal is to help you meet this critical milestone.

Learn more about our Pre-IND Meeting services.

End of Phase 2 (EOP2) Guidance

You have completed Phase 2 and are ready to move forward but need the Agency to review and agree upon your Phase 3 plan and protocol(s). You need to attend an EOP2 Meeting with the FDA. During this meeting, you will present your Phase 3 and submission strategy; it is critical that this is done as effectively as possible to ensure that you are aligned with the FDA before you begin your Phase 3 pivotal program.

ProPharma Group: Continuing to Phase 3

Experts from ProPharma Group will work closely with you to ensure that your End of Phase 2 Meeting is as efficient and effective as possible, helping you obtain feedback from the Agency so that you can continue with your Phase 3 clinical trials.

Learn more about our End of Phase 2 Meeting services.

Pre-NDA Meeting Guidance

You have spent endless amounts of time and money assuring that your product is safe and effective. You need to be sure it will receive FDA approval and are ready to obtain feedback from the Agency. The way to accomplish this? A perfectly executed Pre-NDA Meeting with the FDA.

ProPharma Group: Submission Excellence Personified

We will work with you through the Pre-NDA process to develop a clear and concise strategy, communicate complex information, and strategically execute all responses to the FDA throughout the entire process. Our goal is to ensure that your meeting, submission, and product are as successful as possible.

Learn more about our Pre-NDA Meeting services.

FDA Advisory Committee Meeting Guidance

You have overcome so many hurdles and navigated all of the obstacles that you encountered during the drug development process. The only thing standing between your product and NDA approval is an FDA Advisory Committee Meeting. The success of your product depends on the flawless execution of your meeting strategy.

Trust ProPharma Group to help you navigate this final milestone. We will work with you to perfect your FDA Advisory Committee Meeting strategy and assist with the preparation and execution of this critical meeting.

Learn more about our FDA Advisory Committee Meeting services.

 

Get Expert Guidance for Your Upcoming FDA Meeting

FDA meetings represent crucial milestones in the product development program, which require substantial time and resources to adequately prepare for. No matter what stage of the development process your product is in, ProPharma Group can help you prepare for your next FDA meeting to ensure you get the feedback you need to move into the next phase. To learn more about our regulatory consulting services, contact us today.

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