Regulatory Agency Meetings
Providing expert clinical trial regulatory strategy and consulting services
Our extensive experience managing communications with the FDA and other regulatory authorities can help reduce time to market and conserve patent life. Whether we are providing regulatory strategy consulting, planning meetings, preparing pre-meeting briefing packages, or facilitating communications between the sponsor and the FDA or other regulatory authorities. Our clinical trials regulatory consulting experts guide sponsors through each step of the process – ensuring a consistent program that runs smarter and more efficiently.
Types of meetings we support:
- CDER Pre-Pre-IND and Pre-IND Meetings
- CBER Interact and Pre-IND Meetings
- CDER/CBER End of Phase 1 Meetings
- CDER/CBER End of Phase 2 Meetings
- CDRH Q-submission Meetings, including pre-submission, submission issue, informational, and PMA Day 100
- CDER Pre-NDA Meetings
- CBER Pre-BLA Meetings
- CDER/CBER Review Cycle Meetings, including mid-cycle meetings, late-cycle meetings, and advisory committee meetings
Canada – Health Canada’s Health Product and Food Branch
- HPFB Scientific Advice Meetings
- HPFB Pre-NDS Submission Meetings
EU – European Medicines Agency
- EMA and National Scientific Advice Meetings
- Pre-submission Meetings, including MAA, orphan designation, PIP, and ITF briefing meetings
- SME Briefing Meetings
Considerations for meetings with regulatory agencies
Interfacing with regulatory authorities is extremely important, but… it is not something that is needed frequently unless you are working on a product that is extremely novel. FDA is not a consulting firm and the pharmaceutical/biotechnology industry has sufficient expertise for your company to acquire the information necessary to develop most products. By simply conducting successful milestone development meetings (e.g., for FDA: Pre-IND, End-of-Phase 2, and Pre-NDA/BLA meetings) a company will be able to bring their products to market if they are both safe and efficacious. The goal of clinical trial regulatory authority meetings should be to obtain agreement from them regarding your interpretation of your current data and to confirm your plans for the future.
In the case of a novel (to regulatory authorities) product, there is a need to educate regulators about your product’s mechanism of action, to discuss potential safety concerns and mitigation strategies, and to discuss the means to quantify clinical benefit. These topics need to be discussed with the FDA at a Pre-IND, or earlier at a CDER Pre-Pre-IND meeting or CBER Interact meeting, and with Health Canadian and EU member state competent authority scientific advice meetings.
Adequate preparation and execution of successful meetings will educate regulators and cement a mutually respectful relationship. To accomplish successful meetings, your meeting questions must be focused and your meeting package comprehensive to avoid any otherwise unneeded interactions with regulators. Rehearsals are required until you are prepared to answer any question regulators may ask at the meeting.
We have represented
Our experts have represented product sponsors at virtually every FDA division, as well as Health Canada, EMA and several EU National Authorities.
Thank you to all involved in the End of Phase 1 meeting for our urinary bladder cancer program. The meeting was a great display of preparation, competency and poise. What a team!
Will Robberts, President, Lipac Oncology
Marketing Application Planning Tool
If you’re interested in working with us on your marketing application, download and complete our planning tool to provide us with critical information about your program.
Regulatory Agency Meetings – Your guide to EOP2 meeting preparation
The end-of-phase 2 (EOP2) meeting with FDA is a critical milestone in your development program and likely the most important interaction you will have with the Agency. Getting the most from this meeting can help successfully launch your phase 3 program and help you begin preparing for your marketing application (NDA/BLA) submission. Companies nearing completion of their phase 2 studies or who are planning phase 3 programs will benefit from this webinar.Watch Webinar
David Shoemaker, Ph.D.
Senior Vice President, Research & Development
Kevin Barber, Ph.D.
Vice President, Regulatory Strategy & Submissions