Built for leaders who cannot afford FDA surprises
Beacon Regulatory Services LLC is a boutique executive consulting partner for CEOs, GMs, and RA/QA leaders—especially at foreign and first-time U.S. entrants—who need their FDA registration, device listing, and U.S. Agent footprint to stand up cleanly and hold up under scrutiny.
Typical client scenarios we are asked to fix or lead
Most of our work begins when an executive realizes that “someone needs to own the FDA footprint”— and that the risk, speed, or complexity of U.S. access is now a board-level topic.
Foreign manufacturers entering the U.S.
U.S. Agent representation and establishment record governance.
U.S. importers & commercial hubs
Aligning roles across multiple supply and OEM partners.
Existing & new U.S. manufacturers
Standing up compliant presence before scaling distribution.
Portfolio owners & investors
Rationalizing catalogs and cleaning legacy listings post-M&A.
Contract & OEM manufacturers
Correct facility role definitions to support client submissions.
Renewal & operations teams
Owning the annual registration cycle without disruption.