US FDA Regulatory Analysis Online Service Introduction

FDAlink is now offering an online version of our FDA compliance consulting services. This is less expensive and quicker than the traditional or off-line consulting. Through this, you will receive a quality service with considerable savings in cost and time. Typical clients would save up to 50% of the fee and up to 30% of the off-line consulting time.

Because each of your products is unique, the regulations for each product may also be different. Therefore, it is important to know which regulations applied to your product. We will help you with how.

This online system is different, innovative and comprehensive. When it comes to compliance, there are two basic compliance components: product and facility. While there are many service companies who provide only Establishment Registration and US Agent services for foreign companies, however, this is not enough because it does not address issues about the products. More important aspect is how you can make your PRODUCT complied.

This online system is developed as a product of our long experience to give you more comprehensive and objective analysis of your product in regards to the FDA clearance. In addition, this on-line services are most frequently asked and the most fundamentally vital compliance activities.

This system will tell you in your language what you need to do for both your product and facility.

NOTE: This online service is primarily for clients in food, dietary supplements, and medical device industry.

Online Service Detail

FDAlink will
Type of clients who would benefit from this service
How this online system works
Why choose FDAlink?
Questions?
Fees

FDAlink will:

• Explain which FDA regulations are applied to your product
• Provide you with an executive summary of what you need to do for your product in your native language (Chinese, English, Japanese, Korean, Spanish, Thai, German etc)
• Give you detail description of the regulations in case you want to know more
• Help you comply necessary regulations in your native language
• Serve as the U.S. Agent for your facilities
• Help you update your registration when registration information changes
• Cancel your registration if your facility closes or is no longer required to register

Also, when requested,

• Provide significant discounts on additional and in-depth consulting services for the online clients:
  1. FCE/SID Registration, Labeling Review, FDA Retention/Refusal for imports, Food Additive
  2. 510(k), QSR, CE, ISO for facilities, PMA
• Guide you with FDA’s screening practice for imported goods

Type of clients who would benefit from this service (Food, Dietary Supplement, Medical Device):

• Importers
• Exporters
• Distributors
• Manufacturers
• Re-packers
  

How this online system works:

1. Understand the type of services you will get: Client
2. Information about your product and facility: Client > FDAlink
3. Report on necessary regulations and recommendations: FDAlink > Client
4. Detailed information for requested services: Client > FDAlink
5. Payments for various services: Client > FDAlink
6. Review: FDAlink
7. Confirm & Submit to FDA: FDAlink
   

Why choose FDAlink?

FDAlink US FDA Compliance Consulting has expertise and experience in dealing with many types of case, from complicated cases of new drugs to simple cases, in all of the FDA-regulated industries. We are experienced to understand what exactly you need in various compliance levels.

Unlike other consultants or agents, we are not only an online company. FDAlink is a full-service consultancy that can help you with any FDA problems. You never know what kind of problems or complications you will run into in the future.

Please read more at our Who We Are page.

Questions?
Please go to Contact Us page.

Fees

• Food & Dietary Supplements

• Medical Devices