Building a North America Regulatory Rail: Coordinating FDA, Health Canada, and COFEPRIS for Scale
For manufacturers eyeing North American expansion, the U.S., Canada, and Mexico represent a massive integrated market. However, treating them as a single regulatory block is a mistake. While MDSAP harmonizes quality systems, the registration and representation requirements for each country remain distinct—and often contradictory.
Building a coherent "regulatory rail" means designing a system where a single product change (e.g., a new manufacturing site) triggers the correct, synchronized updates across all three jurisdictions. Failure to coordinate leads to fragmented inventory, where "Lot A" can only be sold in the U.S. while "Lot B" sits in a Canadian warehouse waiting for a license amendment.
The Representation Puzzle
The core friction point is local representation. In the U.S., you need a U.S. Agent (who handles communication but doesn't hold the license). In Canada, you need a Regulatory Correspondent (often tied to the MDL holder). In Mexico, you need a Registration Holder (who legally owns the registration). If you rely on three different distributors to fill these roles, you lose control of your intellectual property and your ability to switch partners. You become a hostage to your distribution channel.
Centralized Control
The executive solution is to separate *regulatory representation* from *commercial distribution*. By holding your own registrations (or using a neutral third-party holder) and appointing independent agents, you maintain the flexibility to change distributors without losing market access. This creates a stable "rail" for your products to ride on, regardless of who is selling them.
How BRS LLC Coordinates the Continent
We provide the central governance to manage multi-country compliance.
- Unified Representation: We serve as your U.S. Agent and coordinate with Canadian/Mexican counterparts to ensure consistent messaging to all three agencies.
- Change Management: When you change a label or site, we map the impact across FDA, Health Canada, and COFEPRIS to prevent compliance gaps.
- Distributor Independence: We help you structure registrations so you retain ownership, protecting your market access rights.