U.S. AGENT

Your Trusted FDA Liaison for Confident U.S. Market Entry

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At Landrich Group, we combine global regulatory expertise with hands-on support to guide your product from early development to successful submissions. For non-U.S. companies, the FDA requires the designation of a U.S. Agent—and we're here to fulfill that role with clarity and confidence.

 

Led by an industry professional with over 30 years of experience, our team—including ISO 13485-certified lead auditors with strong background in ISO 9001 Quality Management Systems (QMS), we deliver accurate, timely, and strategic support at every step your products’ lifecycle.  Whether developing a Regulatory Strategy, preparing for FDA Pre-Submission meetings, engaging with the FDA and other National Competent Authorities (NCA) , or presenting to your Leadership Team or investors, we're by your side. Our proven success metrics for product approvals and inspection results, maintained since 2016, speak for themselves.

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Communication and Representation
We act as your official point of contact with the FDA—submitting applications, responding to inquiries, scheduling inspections, and addressing regulatory matters efficiently and professionally.

Local U.S. Presence

For companies outside the U.S., Landrich Group offers a dependable U.S. based presence, representing your interests, facilitating direct communication with the FDA, and helping to reduce delays, streamline project execution, and minimize international travel.

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Regulatory Compliance Support

Our experts, versed in ISO 13485 and ISO 9001 QMS, review your submissions, labeling, and documentation to ensure compliance with FDA expectations and international standards, helping to prevent setbacks and costly delays

 

Inspection Facilitation

We coordinate directly with the FDA to support inspection readiness for your facilities—whether U.S. based or abroad—ensuring operations and documentation are prepared for smooth, compliant reviews.

 

Prompt FDA Response Support

We manage and respond promptly to FDA requests for clarification or information, ensuring your project stays on track.

 

For non-U.S. companies, the FDA requires the designation of a U.S. Agent. Landrich Group offers trusted U.S. Agent services to streamline communication with the FDA and support a confident, compliant entry into the U.S. market. Backed by ISO 13485-certified leadership, ISO 9001 quality system expertise, and over 30 years of regulatory experience, we provide the clarity, responsiveness, and partnership global companies need to navigate U.S. requirements and achieve successful outcomes.