Market Entry Strategy:
Aligning Global Partners

The Bottom Line: A U.S. importer and a foreign manufacturer needed to launch a new product line, but their regulatory responsibilities were undefined. Beacon Regulatory Services LLC built a "Responsibility Map" to define exactly who owns the data, the listing, and the risk.

The Situation

Launching a new product line involved a complex web of stakeholders: a Foreign Manufacturer, a U.S. Initial Importer, and a network of Distributors. Without clear boundaries, the launch risked:

• **Conflicting Listings:** Multiple entities listing the same device, confusing the FDA.
• **Import Holds:** "Who is the Importer of Record?" questions halting shipments at Customs.
• **Finger Pointing:** No clear owner for Adverse Event Reporting or Recall execution.

The BRS Intervention

• **The Role Map:** Defined explicit regulatory obligations for the Manufacturer (Design Control) vs. the Importer (Complaint Handling).
• **Listing Strategy:** Aligned the FURLS database to match the commercial flow—ensuring the "Importer" field matched the shipping documents.
• **Communication Protocol:** Established a "First Responder" model for FDA inquiries or port questions.

The Outcome

Frictionless Market Entry. The product cleared customs smoothly. All partners know exactly what they are responsible for, and the regulatory record tells a single, coherent story to the FDA.