From Concept to Clearance
We understand that startups operate under tight timelines and budgets. Our lean regulatory approach helps you hit critical milestones, secure funding, and avoid costly pivots.
Regulatory Roadmap
Defining the fastest and most cost-effective path to market for your MVP.
Pre-Submission (Q-Sub) Support
Engaging early with the FDA to de-risk your submission strategy.
Small Business Designation
Qualifying for reduced FDA user fees to preserve your runway.
Investor Due Diligence
Preparing regulatory assets that instill confidence in VCs and angels.
Fractional Regulatory Support
Access world-class expertise without the cost of a full-time hire.