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 services guide sponsors through each step of the process – ensuring a consistent program that runs smarter and more efficiently.

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. As a regulatory affairs services provider, Rho is well suited to prepare you for such meetings.