Helping Your Products Meet FDA Compliance — Fast and Hassle-Free
We guide international manufacturers through every step of FDA registration, listing, and compliance — so you can confidently enter the U.S. market.
Quick Service Overview
Our Expertise
- FDA Registration & Listing
- U.S. Agent Services
- 510(k) Submission
- Labeling & Compliance Review
Why Choose Us
- 10+ years of FDA regulatory experience
- Trusted by global manufacturers across Asia and Europe
- Dedicated bilingual consultants (English & Chinese)
- Fast response and clear communication
Let our experts review your FDA compliance needs today.
About Us
Who We Are
Our Expertise
Our team has extensive experience with FDA compliance for medical devices, cosmetics, OTC drugs, dietary supplements, and more.
We specialize in helping overseas companies register their establishments, list their products, and communicate with the FDA.
Our Vision
What Makes Us Different
- In-depth understanding of FDA regulations (21 CFR)
- Personalized one-on-one consulting
- Transparent, fixed-rate pricing
- Proven track record of successful registrations
Let us together build a flourishing business
When connected with us, you aren’t growing your business alone. We have your back and put in our best to contribute to the entrance of your company products to the U.S. market. So, if you are looking for the right agency that’ll help your products meet FDA compliance fast, we are right here!
Highly Motivated Team with Innovative Ideas
We love what we do and therefore come up with the best possible solutions to help you through every step of FDA registration, listing, and compliance quickly. We are your trusted partners you can count on.
