Concierge U.S. Agent Coverage
FDA mandates a U.S.-based communications interface for all foreign establishments. We replace ad-hoc distributor support with professional, senior-led representation tailored to Asian manufacturers.
- 24/7 accountability for FDA correspondence.
- Strategic inspection scheduling & liaison.
- Audit-ready communication logs.
Listing & Portfolio Clean-Up
Asian manufacturing portfolios often suffer from "phantom data"—legacy listings that don't match current manufacturing reality or brand ownership.
- Removal of duplicate or obsolete entries.
- Correct Product Code (ProCode) alignment.
- Clean records for customs & CBP holds.
Establishment Configuration
Securing your FEI and correctly configuring FURLS roles is critical for multi-site operations and OEM/ODM relationships common in APAC.
- Initial site registration & FEI retrieval.
- Role mapping (Manufacturer vs Repackager).
- Traceable lifecycle maintenance.
Beyond Administration: Installing Global Governance.
Regulatory compliance for APAC-based medical device firms is often a fragmented effort, split between local Quality teams and third-party distributors. This fragmentation creates "Regulatory Debt"—a buildup of inconsistent data, outdated site roles, and undocumented changes that eventually surface during FDA inspections or shipment audits.
At BRS LLC, we design regulatory infrastructure the way boards and investors expect it to work. Leveraging experience at Abbott, Cook Medical, and Baxter, we bridge the gap between Asian manufacturing excellence and U.S. regulatory standards. We don't just file records; we install an operating rhythm that ensures your FDA story always matches your manufacturing reality.
Engagement & SLAs
Structures tailored to global operating tempos.
Project Launch
Fixed-scope U.S. entry for new product families.
Governance
Continuous stewardship and U.S. Agent representation.
Senior Advisory
Judgment-driven support for inspections and pivots.