US Agent

Reliable US Agent Services for Your FDA Compliance

ADB CRO facilitates smooth communication with the FDA, providing comprehensive US agent services to help you navigate regulatory requirements and ensure compliance with all FDA standards for successful market access and product approval.

Comprehensive US Agent Services

As a foreign company entering the U.S. market, ensuring FDA compliance is a critical step. ADB CRO provides end-to-end US agent services, acting as your official representative to facilitate communication and compliance with FDA requirements.

What We Offer

  • Official FDA Representation
    As your designated US agent, we handle all FDA correspondence, notifications, and inquiries to ensure smooth regulatory processes.
  • Pre-Submission Support
    We guide you through preparing and submitting documents, ensuring they meet FDA expectations and avoid delays.
  • Regulatory Compliance Assistance
    Our team of experts helps ensure your products, labeling, and processes comply with FDA standards.
  • Crisis Management
    In case of an FDA inspection, warning letter, or urgent request, we provide prompt support to address issues effectively.
Please note that ADB U.S. Agent Services & the U.S. Agent has no responsibility related to reporting of adverse events under the Medical Device Reporting regulation (21 CFR Part 803)

Why Choose ADB CRO?

  • Experienced Professionals
    Leverage our deep knowledge of FDA processes and regulations.
  • Seamless Communication
    We bridge the gap between your team and the FDA for uninterrupted progress.
  • Tailored Solutions
    Services designed to meet the unique requirements of your product and business.

Partner with ADB CRO for simplified FDA representation and compliance!

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Global Impact

Our mission extends beyond delivering products and services; we are dedicated to making a lasting positive impact across the globe. Through our commitment to excellence in customer service, product innovation, and regulatory compliance, we drive sustainable growth, foster trust, and set new standards within our industry. Each initiative is part of our vision to empower communities, support industries, and contribute meaningfully to a better world.

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