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Regulatory
Expertise.

95%

U.S.-Based

25mi

from FDA HQ

12hr

Response Time

We assist foreign manufacturers with FDA facility registration for food, dietary supplements, and cosmetic products. Our experienced consultants guide you through every step of the process, ensuring that your facility information, product categories, and contact details are accurately entered into the FDA system.

Based in Columbia, MD near Washington, DC, our U.S.-based team stays informed on regulatory updates and best practices. We review every submission carefully to reduce errors that could lead to delays, rejections, or compliance issues.

With FDA Consults, you receive clear guidance, honest advice, and dependable support. Our goal is to make your registration process smooth, accurate, and stress free, so you can focus on growing your export business.

Foreign manufacturers are required to appoint a U.S. Agent as part of their FDA registration. FDA Consults serves as your official communication point with the FDA, receiving regulatory notices, inspection communications, and compliance inquiries on your behalf.

Unlike remote or overseas agents, we are physically located in the United States and operate within 30 miles of FDA headquarters. This proximity allows us to stay closely connected to regulatory developments and expectations.

When you choose FDA Consults as your U.S. Agent, you gain a reliable partner who represents your interests responsibly. We act with professionalism, confidentiality, and urgency,  giving you peace of mind in regulatory matters.

FDA facility registrations must be renewed annually and updated whenever there are changes to ownership, address, products, or operations. Missing a renewal deadline can result in inactive status and shipment delays.

Our consultants maintain detailed records of your registration history and compliance status. This allows us to quickly assist with audits, reviews, and regulatory inquiries when needed.

By partnering with FDA Consults for renewals and compliance support, you protect your market access and reduce regulatory risk. We focus on long-term compliance, not short term shortcuts.

Successful entry into the U.S. market requires more than just FDA registration. Exporters must understand basic regulatory expectations, documentation requirements, and compliance responsibilities before shipping. We help you review your registration status, U.S. Agent designation, and export readiness to identify potential gaps that could cause customs holds or shipment refusals.

With experience serving food, supplement, and cosmetic exporters across multiple regions, we understand common challenges faced by international manufacturers. Our guidance is practical, realistic, and tailored to your business.

Our export readiness support helps you enter the U.S. market confidently and professionally. By preparing in advance, you reduce costly mistakes and build credibility with importers and buyers.

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About Us

FDA Consults is an independent consulting firm based in Columbia, Maryland, providing FDA registration and U.S. Agent services to foreign manufacturers worldwide. We specialize in helping food, dietary supplement, and cosmetic exporters understand and meet U.S. regulatory requirements with clarity, accuracy, and transparency.

Located near Washington, DC and within close proximity to FDA headquarters, we stay informed on regulatory developments and industry best practices to better serve our clients.

Our mission is to simplify FDA compliance for international manufacturers and help them enter the U.S. market responsibly and confidently. We believe that regulatory consulting should be honest, educational, and focused on long-term compliance, not misleading promises or shortcuts.

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