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Title Author Hits
Executive White Paper: The "Phantom" Listing Risk Beacon RS LLC 0
What Investors and Strategic Buyers Expect from Your FDA Registration Story Beacon RS LLC 0
Building a North America Regulatory Rail: Coordinating FDA, Health Canada, and COFEPRIS for Scale Beacon RS LLC 0
Your Website, Your Labeling, and Your Device Listing: Why FDA Cares if the Story Doesn’t Match Beacon RS LLC 0
What FDA Sees Before an Inspection: Red Flags in Your Establishment Registration and Device Listings Beacon RS LLC 0
Cleaning Up Legacy FDA Device Listings After M&A, Distributor Changes, or Product Discontinuations Beacon RS LLC 0
Annual FDA Registration Renewal: How to Get Through Oct–Dec Without Surprises Beacon RS LLC 0
Avoiding Customs Holds: How FDA Registration and Product Codes Drive Clearance at the U.S. Border Beacon RS LLC 0
Device Listings for OEMs, Contract Manufacturers, and Private Labelers: Whose Name Goes Where? Beacon RS LLC 0
U.S. Agent, Importer, Initial Importer: Who Does What? Beacon RS LLC 0

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Beacon Regulatory Services LLC

Beacon Regulatory Services (BRS) LLC acts as the decisive U.S. regulatory interface for medical device manufacturers worldwide.

We replace administrative uncertainty with audit-ready precision—managing FDA Establishment Registrations, Device Listings, and U.S. Agent obligations.

Headquarters
9105 E 56th St, Ste J #2057
Indianapolis, IN 46216, USA
Direct Line
+1 (317) 662-0910
Regulatory Inquiries
info@beaconfda.com
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Capabilities
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Engagement Process
Streamlined Onboarding
1
Submit Scope
Share device type & goals via secure intake.
2
Analysis & Proposal
We confirm regulatory pathway & costs.
3
Execution
Immediate filing & U.S. Agent appointment.
Response Target: 1 Day
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Verified Heritage:
Abbott Cook Medical Baxter
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