The Governance Standard

We don’t just file records.
We install governance.

Regulatory compliance should never be a series of reactive fire drills. Leveraging two decades of enterprise experience at **Abbott, Cook Medical, and Baxter**, Beacon applies a proprietary **4-Phase Operating System** to stabilize your global footprint and eliminate avoidable FDA exposure.
 

The Beacon Regulatory Operating System

Moving organizations from tactical "scramble" to strategic "steady state."

PHASE 01

Diagnostic

We reconcile your physical catalog against FDA-facing records to identify "phantom" listings and legacy data drift that trigger shipment holds and audit friction.

PHASE 02

Architecture

We clarify establishment roles and map Product Codes correctly, establishing a logic that stays defensible as you scale SKUs, manufacturing sites, or global distributors.

PHASE 03

Execution

We formalize the U.S. Agent appointment and execute filings inside the DRLM/FURLS systems—producing documented proof-of-work that supports supply continuity.

PHASE 04

Governance

We maintain a permanent, audit-ready posture through continuous monitoring and renewal management—where compliance becomes durable rather than temporary.

The Systemic Advantage

Most regulatory failures are not caused by bad intent—they are caused by **Process Drift** and fragmented ownership.

Without an installed operating system, data degrades the moment it is filed. The Beacon approach includes built-in checkpoints that align your commercial catalog with your regulatory record—insulating leadership from last-minute renewals and shipment holds.

Strategic Comparison

Typical Approach Beacon Governance
"File & Forget" Continuous Monitoring
Reactive Defense Audit-Ready Evidence
Variable/Hourly Fees Flat Governance Rate
 

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