How can we help you?
FDA Registration & Listing
We handle the entire registration process for your establishment and products.
Services include:
- Establishment registration (domestic & foreign)
- Device and drug listing
- Annual renewal and updates
- SPL (Structured Product Labeling) submission support
U.S. Agent Services
As your official U.S. Agent, we act as your communication link with the FDA.
Our role includes:
- Responding to FDA communications on your behalf
- Supporting FDA inspection coordination
- Providing guidance on compliance and labeling
510(k) Submission & Regulatory Support
We help you prepare and submit a complete and compliant 510(k) premarket notification.
Our services:
- Product classification and regulatory strategy
- Preparation and formatting of submission documents
- FDA correspondence and deficiency response
UL & CSA Certification Assistance
If you’re planning to sell your product in the United States, meeting UL standards is essential for both market entry and consumer safety assurance. We simplify the entire certification journey — from evaluation to approval — so you can focus on growing your business.
Our services:
- UL & CSA Certification Consulting
- Product Evaluation & Safety Testing
- Technical Documentation Review
- Factory Audit & Compliance Inspection
- End-to-End Project Management
Labeling & Packaging Compliance
Ensure your product labels meet all FDA requirements before entering the market.
We review:
- Ingredient and claims compliance
- Label layout, warning statements, and format
- OTC Drug Facts and cosmetic labeling
GMP & Import Support (Optional Add-on)
- FDA inspection readiness assessment
- Import detention and warning letter response
- Good Manufacturing Practice (GMP) consulting
Who We Serve
We proudly support clients from around the world, including:
- Medical device manufacturers
- Cosmetic and skincare brands
- OTC drug and supplement companies
- International distributors and exporters
Whether you are based in Asia, Europe, or Latin America, our team helps you enter and stay compliant in the U.S. market.
Global Partners
SUNREACH
暘致國際認證台灣總部
電話：886-4-24758336
傳真：886-4-24758230
地址：台中市南屯區海德街29號
E-mail:service@sunreach.com
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!