U.S. Agent Services

U.S. Agent Services

Introduction

With more than 27 years of leadership in the medical device industry, we provide trusted regulatory and quality system support to help international manufacturers establish and maintain a strong, compliant presence in the United States. Our services are designed to streamline communication with U.S. regulatory authorities, strengthen quality system readiness, and support your organization in meeting FDA expectations with confidence and clarity.

U.S. Agent Services

As your designated U.S. Agent, we serve as your official point of contact with the U.S. Food and Drug Administration (FDA), ensuring that all regulatory communications are received, relayed, and addressed promptly. Our role supports your compliance obligations by facilitating clear and timely information exchange between your organization and the FDA, helping you maintain a reliable presence in the U.S. market.

Our responsibilities include:

  • Receiving FDA communications, inquiries, and inspection notices on your behalf

  • Promptly forwarding FDA requests to the appropriate contacts within your organization

  • Supporting timely and accurate responses to FDA correspondence

  • Assisting foreign, as well as local, establishments in understanding expectations related to registration, listing, and communication requirements

  • Providing a stable, trusted U.S.‑based representative to streamline regulatory interactions

Regulatory decisions remain with your organization, but we ensure that communication with the FDA is handled efficiently and professionally.

QMS Services (Separate Fees Apply)

QMS Preparation for FDA Inspections

We support your organization in preparing for FDA inspections by helping you understand inspection expectations, reviewing your quality system documentation, and identifying areas that may require strengthening. This service focuses on readiness, clarity, and alignment with FDA quality system requirements.

QMS Quality & Regulatory Work Preparation

We assist with preparing and organizing quality and regulatory documentation to support your ongoing compliance activities. This includes guidance on quality system structure, documentation practices, and regulatory workflow preparation to help ensure your processes meet FDA expectations.

Each QMS service is offered as a separate, fee‑based engagement, allowing you to select the level of support that best fits your organization’s needs.