FCG-OS
Regulatory Program Intelligence
Today, FDA Connection Group combines regulatory strategy, regulatory operations, quality experience, and hands-on eCTD execution—and is developing FCG-OS™ as the next step in structured regulatory program intelligence.
FCG-OS™ is an integrated regulatory program intelligence platform, designed to help clinical-stage companies plan, manage, and execute FDA submission strategies from IND through pivotal trials and BLA approval.
FCG-OS™ Programs
Modular programs that work together to give you a complete regulatory operating system.
01 Program Intelligence and Regulatory Baseline™
Centralized program data, milestones, and regulatory baseline with real-time status and risk tracking.
02 Submission Planning and Readiness
Plan and prepare INDs, amendments, annual reports, CSRs, and BLAs with structured workflows.
03 eCTD Execution and Lifecycle Management
Document assembly, publishing, validation, transmission, and submission tracking.
04 FDA Interaction Management
Type C/D meeting planning, briefing packages, FDA commitments, and response tracking.
05 Compliance and Quality Management
Document control, SOPs, training, audit readiness, and regulatory compliance tracking.
06 AI Insights (Developing)
Supervised AI to analyze regulatory data, identify risks, and provide strategic recommendations.
Key Benefits
Complete Regulatory View
One source for programs, submissions, and commitments.
Proven Workflows
Based on real-world FDA experience.
Stay Ahead of Milestones
Anticipate what’s next, not just react.
Reduce Risk
Identify gaps and issues early.
Increase Efficiency
Streamline regulatory operations.
Built for Clinical-Stage Companies
Scalable from IND to BLA.
The Bigger Picture
FCG-OS™ integrates regulatory expertise, structured program data, controlled workflows, and AI-enabled insights to help you move from IND development through pivotal trials and BLA readiness — with a clearer, more predictable path to FDA approval.
Programs
FDA Submissions
FCG-OS™ Milestones
FCG-OS™ FDA Interaction
FCG-OS™ Documents
FCG-OS™ Compliance
FCG-OS™ Risk Management
FCG-OS™ AI Insights
More information coming soon.