US Agent Services

Reliable Representation

We serve as your trusted U.S. Agent to support communication, compliance, product registration, and regulatory engagement with FDA.

Your Trusted FDA Point of Contact in the United States

For foreign drug, device, supplement, and biologics manufacturers, the FDA requires a designated U.S. Agent to facilitate communication, support regulatory inquiries, and ensure timely response to compliance obligations.

Vertentis provides professional, dependable U.S. Agent services backed by deep FDA and industry experience. We act as your regulatory representative in the United States, supporting interactions with FDA, coordinating responses, and helping you maintain compliance with all applicable requirements.

Whether you are entering the U.S. market for the first time or maintaining ongoing operations, we ensure your organization has a credible, responsive, and knowledgeable partner supporting every FDA communication.

Formal FDA Point of Contact

Serving as the official U.S. Agent for foreign manufacturers as required under FDA regulations.

Regulatory Communication Management

Receiving, reviewing, and coordinating responses to FDA inquiries, notices, inspection communications, and compliance actions

Registration & Listing Support

Assistance with establishment registration, product listing, and updates through FDA systems (e.g., FURLS, SPL).

Emergency Contact Availability

Timely response to urgent FDA notifications, holds, and critical communications

Ongoing Compliance Support

Routine check-ins and guidance to ensure your organization stays aligned with FDA requirements throughout the year

Companies that partner with Vertentis benefit from:

Faster, clearer communication with FDA
Reduced confusion or delays in responding to regulatory requests
Improved accuracy and completeness of submissions and updates
Stronger compliance posture and reduced regulatory risk
A trusted U.S.-based partner aligned with your business goals
Peace of mind knowing FDA communications are handled promptly and professionally

How Our Team Helps You Strengthen Quality & Compliance

Discovery & Assessment

Begin with a focused conversation to understand your quality, regulatory, and operational needs. We discuss your challenges, goals, and current state so we can determine where Vertentis can make the greatest impact.

Data & Documentation Review

We conduct a structured review of your existing processes, quality records, SOPs, findings, submissions, or inspection history. This step ensures we have a complete picture before providing recommendations or strategy.

Strategy & Action Planning

We present a clear, tailored roadmap, whether focused on FDA compliance, QMS optimization, inspection readiness, or CAPA improvement. You’ll receive practical, step-by-step recommendations aligned with regulatory expectations and your operational realities.

Execution & Support

We partner with your teams to implement the plan, build or refine processes, and support ongoing compliance. You’ll stay informed throughout as we help strengthen systems, reduce risk, and maintain readiness.