How We Work

Flexible Structures. Predictable Execution.

Beacon Regulatory Services LLC is structured to meet executives where decisions are made. Whether you require a discrete market entry initiative, standing regulatory governance, or senior-level intervention during a critical event, our engagement models are designed to align with your operating tempo, risk exposure, and regulatory accountability—without unnecessary complexity or overhead.
 
Project Based

Market Launch

Designed for organizations entering the U.S. market for the first time or introducing new devices under tight timelines. This engagement delivers a clearly defined scope, fixed accountability, and a clean regulatory foundation that withstands FDA scrutiny from day one.

  • Importer and ownership strategy aligned to FDA expectations
  • FDA Establishment Registration execution and verification
  • Device Listing creation with data validation and controls
  • First-shipment readiness and pre-market risk checks
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Annual Retainer

Governance

This model provides continuous regulatory coverage and executive assurance. Beacon acts as your standing U.S. Agent and regulatory steward—monitoring compliance, managing FDA correspondence, and preventing avoidable regulatory drift that exposes leadership to operational and reputational risk.

  • Official U.S. Agent appointment and accountability
  • FDA correspondent handling and issue triage
  • Annual registration and device listing renewals
  • Scheduled record audits and compliance health checks
Secure Coverage
 
Event Driven

Advisory

Targeted senior advisory for moments that demand immediate regulatory judgment. This engagement is activated when leadership requires experienced counsel to resolve inspections, enforcement actions, or strategic pivots without destabilizing ongoing operations.

  • Inspection preparation and executive-facing audit support
  • Import alert, detention, and hold resolution
  • 510(k) positioning and strategic memo development
  • Labeling, claims, and promotional risk assessment
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Service Level Commitment

Regulatory risk does not operate on a schedule. Our Service Level Agreements are designed to ensure leadership is never waiting on regulatory answers when business decisions must be made.

Speed

One business day response target for critical regulatory inquiries and escalation events.

Access

Direct access to senior regulatory leadership—no junior filters, no delegation gaps.

Transparency

Continuous access to regulatory documentation, certificates, and proof-of-work artifacts.