Take Command of Your FDA Approval
Guiding Your Business Right - in Quality & Regulatory
We transform regulatory complexity into your greatest competitive advantage. This is Mission Control for the world's most ambitious medical innovators.
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Submission Success Rate (%)
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Successful FDA Submissions & Interactions
$0M+
In Client Delay Costs Averted
System Diagnostic
Initiate Preliminary Threat Assessment
Engage the GYBR Regulatory Model™ to get a high-level, automated analysis of your product's potential challenges. This is the first step to achieving strategic clarity.
ANALYZING REGULATORY VECTORS...
ANALYSIS COMPLETE.
RISK LEVEL
EST. TIMELINE
KEY CHALLENGE
The results above are generated by our automated regulatory model based on the data provided. This preliminary diagnostic is designed to highlight key strategic variables. A comprehensive Strategy Briefing with our experts is necessary to validate these findings and architect a definitive, de-risked regulatory pathway.
Command Center Modules
Your Arsenal for Regulatory Dominance
Integrated solutions designed to provide clarity, speed, and strategic advantage at every stage.
Pre-Market Strategy & Vision
Develop a bulletproof regulatory roadmap from day one. We identify the optimal pathway - 510(k), De Novo, PMA - and build the strategy to get you there faster.
Quality System Fortification (QMS)
Construct an inspection-ready Quality Management System that doesn't just comply, but drives efficiency. We turn your QMS into a competitive asset.
Post-Market Surveillance & Defense
Proactively monitor your product's performance and manage post-market obligations with precision. We anticipate issues before they become threats to your business.
Interactive Mission Map
Visualize the Regulatory Pathway
This isn't a checklist; it's a dynamic, 3D journey. Understand every milestone, checkpoint, and strategic decision point in a way you've never seen before. Click and drag to explore.
Live Intelligence Feed
The Pulse of the Regulatory World
/FDA_ALERTS
/GYBR_STRATEGIC_INSIGHTS
/CLIENT_WINS
The System Architect
The Insider Advantage, Personified
Founder & CEO
Babatunde Babalola
"After two decades inside the FDA and leading quality at Pfizer, I didn't just learn the rules - I learned the mindset. I know how regulators think, what they look for, and how to build a case for approval that is undeniable. We don't just help you comply; we give you the insider's playbook."
Ready to Launch Your Mission?
Schedule a confidential Strategy Briefing. Let's build your roadmap to market dominance. Your product is too important to leave to chance.