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A boutique, executive-level entry point into the U.S. market—bringing together FDA registration strategy, device listing governance, and U.S. Agent accountability for foreign and domestic manufacturers.
- FDA Establishment Registration
- Device Listing Governance
- U.S. Agent of Record
Choose Your Path
Request an Executive Consult
Meet with a senior regulatory consultant to clarify scope, risk, and timelines for your U.S. FDA strategy.
See the Operating Cadence
Understand how we structure intake, validation, and execution so your leadership team knows exactly what will happen when.
Minimum Inputs
Review the concise checklist of information we require from your team to move quickly without rework.
U.S. Agent FAQs
Clarify roles, responsibilities, and typical scenarios when BRSLLC serves as your U.S. Agent of record.
What to expect
We operate as an extension of your leadership team—using a documentation-forward, consulting-style approach that avoids rework and keeps your FDA posture stable over time.
- ✓ Scope clarity for executives: We separate true regulatory obligations from “nice-to-have” activities so you can prioritize budget, risk, and timelines with confidence.
- ✓ Minimum inputs, maximum signal: We define the smallest, high-confidence data set needed from your teams to execute quickly without repeated information requests.
- ✓ Audit- and deal-ready records: We document decisions, submissions, and renewals so they support internal audits, due diligence, and future inspections.
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1 What we do (Scope)
We design and run the operating playbook for your FDA establishment registration, device listings, and U.S. Agent activities. The mandate: reduce uncertainty, prevent rework, and keep your FDA footprint accurate, current, and defensible.
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2 Minimum Inputs Required
- Company details (legal name, physical address, primary regulatory contacts)
- Establishment context (manufacturer, specification developer, importer, repackager/relabeler)
- Device portfolio (product codes, proprietary names, high-level indications for use)
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3 The Operating Cadence
Intake → Validation → Execution → Governance. We validate your inputs against FDA databases, close gaps before submission, and then provide a confirmation packet, calendarize renewals, and agree how changes and exceptions will be managed going forward.
Ready to professionalize your FDA interface?
Beacon Regulatory Services LLC acts as your boutique regulatory command center—aligning scope, timelines, and governance so U.S. registrations, device listings, and U.S. Agent obligations stay clean, auditable, and predictable.