Did you know? Reed Tech helps global companies comply with FDA regulations and efficiently enter the US market through dedicated US Agent Services. We serve as the FDA point of contact for non-US based drug, biologic and device establishments on behalf of companies that are based outside of the US.
Understanding the Role of US Agent Services
US Agent services are essential for non-US based medical device manufacturers seeking to introduce their products to the US market. The US Food and Drug Administration (FDA) has stringent regulations governing the approval and sale of medical devices, and understanding and adhering to these requirements is critical. Reed Tech can provide US Agent services, helping manufacturers navigate the complex regulatory environment and streamline their entry into the US market.
What we do:
Serving as the FDA point of contact, we:
- Handle registration, listings, communications
- Provide FDA compliance support
- Leverage our regulatory expertise on clients’ behalf
Who We Serve:
Reed Tech is ideal for non-US based companies that:
- Lack an existing US presence, are non-US based
- Have limited regulatory expertise
- Seek FDA guidance from a local partner
How we help:
Key Benefits:
- Leverage our FDA knowledge
- Accelerate US market access and compliance
- Ensure clear communication with FDA through an experienced liaison
- Focus internal resources on core areas
- One-stop shop for Establishment Registration and US Agent Services
In a landscape where regulatory requirements are constantly evolving and competition is fierce, having a trusted MedTech partner can make all the difference. By leveraging Reed Tech for the services of a specialized US Agent, medical device manufacturers can focus on what they do best—developing innovative solutions that improve patient outcomes—while ensuring their products meet the rigorous standards set by US regulators.
Do you have questions about US Agent services? Reed Tech is currently accepting regulatory advisory service requests for medical device manufacturers, cosmetics makers and pharmaceutical companies. Contact here