Regulatory certainty for the growth phase.
Beacon Regulatory Services (BRSLLC) was created for leadership teams that need senior regulatory judgment, not just form-filling. We translate FDA expectations into practical, stepwise plans for establishment registration, device listing, and U.S. Agent coverage.
"We operate in the gap between strategy and execution. Our job is to make sure your FDA footprint matches your commercial ambition—without exposing you to avoidable compliance risk."
Bridging the gap between "Big Pharma" resources and SME reality.
Beacon Regulatory Services LLC exists for one reason: to give small and foreign device manufacturers access to the same level of regulatory judgment large companies rely on.
We saw a pattern: smaller and overseas teams were expected to meet "big company" FDA expectations without "big company" resources. We close that gap with founder-led support anchored in real-world submission and inspection experience.
We do not replace your Notified Body or full in-house regulatory department; instead, we right-size your U.S. registration and listing activities so they are clear, defensible, and sustainable.
The BRS Standard
We help you translate FDA expectations into a clear scope, realistic timelines, and documentation that makes sense to auditors, business leaders, and FDA reviewers.
Strategic Clarity
Clarifying whether you need U.S. Agent, establishment registration, and device listing—and in what order—before you spend a dollar.
Data Integrity
Cleaning up inherited or inconsistent FDA device listings so they match your current portfolio and commercial strategy.
Audit Readiness
Building simple, auditable processes your team can maintain year after year without a massive in-house RA department.
Built for specific regulatory scenarios.
Non-U.S. Manufacturers
Planning first U.S. entry.
- Clear stepwise path to entry
- U.S. Agent representation
- FDA correspondence handling
U.S. SMEs
Cleaning up legacy listings.
- Portfolio rationalization
- Retiring obsolete entries
- Closing compliance gaps
Distributors
Representing foreign OEMs.
- Defining regulatory roles
- Aligning listings to supply chain
- Managing importer duties
Investors / Startups
Preparing for diligence.
- Realistic FDA roadmaps
- Aligning milestones to funding
- Documenting controls