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US FDA AGENT AND FDA REGISTRATION AGENT SERVICES
Any foreign company that wished to sell food or beverage products, medical devices, cosmetics, or drugs in the U.S. must do so via an authorized US FDA Agent. Also, companies will require an FDA registration agent.
- Reliable
- Fast Communication
- 10 Years Experience
WHAT IS A U.S. FDA AGENT ?
US FDA agent may be a private company or an individual that resides in the U.S. and, as such, is subject to U.S. legislation. Foreign businesses must provide details about their US FDA agent, including their registered address and telephone number. The FDA registration agent acts as an intermediary between the FDA and the foreign establishment. The FDA contacts the U.S. Agent directly in the case of any updates relating to registration to approval.
WHAT ARE THE U.S. AGENT RESPONSABILITIES?
COMMUNICATION WITH THE FDA
Communicate directly with the FDA on your behalf
FAST REPLY
Quickly and efficiently respond to any questions or queries arising from either the FDA or the foreign establishment, in relation to applications or approvals.
ORGANIZE INSPECTIONS
Coordinate between the FDA and the foreign establishment to organize inspections.
SMOOTH FLOW
Ensure a smooth flow of communication between the FDA and all of our foreign clients
Why Choose Cosmereg as Your U.S. FDA Agent?
When expanding into the U.S. market, compliance with FDA regulations is crucial for businesses in the cosmetic, dietary supplement, food, and pharmaceutical industries. Appointing a reliable and experienced U.S. FDA Agent is not just a regulatory requirement—it’s a strategic decision that ensures smooth operations and mitigates compliance risks.
1. Industry Expertise & Regulatory Knowledge
At Cosmereg, we specialize in FDA regulatory compliance, offering tailored solutions for foreign manufacturers, distributors, and brand owners. Our in-depth knowledge of 21 CFR regulations and years of experience working with international clients set us apart as a trusted regulatory partner.
2. Direct Communication with the FDA
The FDA requires a U.S. Agent to act as a point of contact for all official communications, including inspections, compliance inquiries, and regulatory notifications. Cosmereg ensures prompt and professional responses to the FDA, preventing delays and potential compliance issues.
3. Hassle-Free Registration & Compliance Support
We handle the entire FDA registration process, including:
✔ Food Facility Registration (FFR)
✔ Cosmetic Facility Registration (MoCRA)
✔ Medical Devices Establishment Registration and Listing
✔ Drug Establishment Registration (NDC & OTC Monographs)
Our proactive compliance support helps you avoid costly penalties and import refusals.
4. Support During FDA Inspections
FDA inspections can be challenging, but with Cosmereg as your U.S. Agent, you gain a dedicated team that assists with:
✅ Pre-inspection preparation
✅ Guidance during FDA audits
✅ Post-inspection corrective actions (if required)
5. Multinational Client Experience
We serve a diverse range of clients, from multinational corporations to small businesses, ensuring personalized service based on your business size and regulatory needs. Our familiarity with different industries means we can anticipate challenges and provide customized compliance solutions.
6. Competitive Pricing & Dedicated Support
Unlike generic registration services, Cosmereg offers personalized support at competitive rates, ensuring your business remains compliant without unnecessary costs. Our team is always available to answer regulatory questions and keep your operations running smoothly.
7. Risk Mitigation & Market Access
Non-compliance can result in import holds, product seizures, and legal actions. By appointing Cosmereg as your U.S. FDA Agent, you protect your brand’s reputation, ensure uninterrupted market access, and maintain regulatory confidence in your products.
Get Started Today
Let Cosmereg handle your FDA regulatory needs while you focus on growing your business. Contact us today to appoint us as your U.S. FDA Agent and ensure seamless compliance with FDA requirements. Click on the link below to start based on your industry:
