Regulatory infrastructure for MedTech growth.

Beacon Regulatory Services (BRSLLC) is a founder-led regulatory services firm focused on helping medical device manufacturers enter and stay in the U.S. market. We operate where commercial ambitions meet FDA expectations—establishment registration, device listing, U.S. Agent, and adjacent regulatory advisory.

This page is designed for investors and strategic partners who want a clear view of the business thesis, model, and early growth priorities. Detailed financials and metrics are shared in follow-up conversations under appropriate confidentiality.

At a glance

• Sector: MedTech regulatory services (U.S. FDA–focused).
• Clients: Foreign and U.S. device manufacturers, distributors, and investors.
• Core services: U.S. Agent, FDA establishment registration, listing governance, portfolio clean-up.
• Model: High-expertise services, project + recurring maintenance, founder-led delivery.

Complexity keeps rising

Device manufacturers face increasing expectations around registration, listing accuracy, post-market surveillance, and international alignment. Many SMEs lack senior in-house regulatory capacity to keep pace.

First-time entrants need a guide

Foreign manufacturers and emerging companies depend on U.S. Agents and advisors to convert intent into compliant, auditable FDA footprints. Missteps can delay launch or trigger avoidable enforcement.

Renewal is not optional

Device listings, registrations, and U.S. Agent obligations renew annually. As portfolios evolve, there is recurring demand for clean-up, rationalization, and ongoing governance.

Specialist services with repeatable rails.

BRSLLC focuses on structured, repeatable regulatory services that lend themselves to standard scopes, clear timelines, and audit-ready documentation. The firm is designed to be lean, technology-enabled, and anchored in senior regulatory leadership.

Over time, the objective is to build durable client relationships around “regulatory rail”: once a client’s U.S. footprint is in place, BRSLLC can support renewals, portfolio updates, and adjacent advisory work as markets and regulations evolve.

Current and planned revenue streams

• Core services: U.S. Agent, establishment registration, device listing setup.
• Portfolio clean-up: rationalizing legacy listings and retiring obsolete entries.
• Advisory: executive-level regulatory guidance for launches, diligence, and audits.
• Maintenance: annual renewals and ongoing listing governance for existing clients.
• Future: expansion to Canada/Mexico regulatory support as scale allows.

What we typically discuss

• Growth priorities across core services and geographies.
• Hiring roadmap for regulatory, operations, and client support roles.
• Technology enablement (intake, workflow, and knowledge assets).
• Unit economics, pricing structure, and client mix over time.

Investment & governance preferences

• Structured, milestone-aligned use of capital.
• Clear governance, reporting cadence, and defined decision rights.
• Respect for regulatory independence and client confidentiality.
• Long-term orientation toward value creation, not short-term volume.