At Launch and Logic, we provide regulatory and strategic guidance designed to accelerate innovation while ensuring compliance with FDA expectations. From startups to global enterprises, our services help align product development with both regulatory and patient-centered goals.
Our key service areas include:
Develop proactive strategies that identify requirements and milestones from concept through post-market. We help you anticipate hurdles and chart the most efficient path for FDA alignment.
Integrate regulatory, clinical, and human-factors considerations into your development process. We support evidence generation, transparency, and usability—elements critical to digital mental health and AI-enabled adoption.
Design responsible AI pathways, including pre-determined change control plans (PCCPs), to support iterative improvement while maintaining regulatory confidence.
Craft robust clinical and real-world evidence strategies for demonstrating safety, effectiveness, and human-centered value.
Uncover gaps in regulatory readiness, evidence, or usability. We provide actionable recommendations that align with FDA and business objectives.
Prepare for FDA interactions, from Q-Subs to advisory committee meetings. We help craft clear, evidence-based narratives that foster productive engagement with regulators.
