Combination Products
FDA Meeting Preparation & Engagement
Our team, which includes former FDA professionals, has extensive experience in the submission process. We represent and assist our clients in navigating their interactions with the FDA, including meeting preparation and addressing potential inquiries, with the goal of making the process straightforward and less stressful.
Regardless of if you are embarking on an initial INTERACT or Pre-IND meeting, or if you are looking to engage with FDA in an EOP2, Pre-NDA, Pre-BLA, or Pre-Submission meeting, we can assist.
Our company integrates innovative approaches, world-class scientific principles, regulatory proficiency, and a committed team to deliver combination product regulatory design and development solutions that yield a positive impact on public health and the quality of life for patients.
Guiding You Every Step of the Way
- Represent clients in interactions with FDA
- Preparation for FDA meetings
- FDA Advisory Panel meeting preparation