US FDA REGISTRATION





Business owners or operators of places of business, i.e., establishments or facilities who does the production and or distribution intending for use / sale in the United States are required to register annually with FDA. This process is known as FDA establishment registration.

THE NEW SIMPLE, FAST WAY TO START SELLING YOUR PRODUCTS IN US MARKETS.

Online application, fee payment and round the clock service of QARA experts makes CLIENTS convenient from across the globe..

We welcome manufactures and traders of MEDICAL DEVICE, DRUGS, API, COSMETICS, FOOD & NUTRACEUTICALS across the GLOBE to do business with us and benefit QARA services.

Lowest FEE CHALANGE !!!

Contact us for QUICK action





 

The following manufactures can contact us for completing the US FDA Registration and Listings.


Cosmetics


  • Voluntary Cosmetic Registration Program(VCRP/CPIS)
  • Cosmetics Labeling Review
  • US Agent Service

 

Drugs (Human and Animals)


  • Register your establishment with FDA
  • Request NDC Labeler code for the establishment
  • Assistance in assigning labeler code
  • List the drugs with FDA
  • SPL File preparation
  • US Agent service

 

Food (Human and Animals)


  • Registration of Food Facilities
  • LACF Registration (Acidified & Low-Acid Canned Food)
  • Dietary supplement facilities
  • Assistance in Prior notice submission
  • Food Contact Substances guidance and processing
  • Food Product Categories guidance
  • US Agent service

 

Medical Devices


  • Premarket Notification(510k)
  • Medical Device Establishment Registration
  • Medical Device Listing
  • Medical Device Label review.
  • US Agent service

 

Vaccines, Blood, Biologics


  • Register your establishment with FDA
  • List the drugs with FDA
  • US Agent service

 


Cosmetics (Applicable Fees)


Cosmetic Establishment Registration (VCRP) Assistance $ 449 / Establishment
Ingredient Statement Filing (CPIS) $ 649 / Product
Label Review $ 649 / Product

 


Drug (Applicable Fees)


Registration, Labeler code Request & US Agent service $ 649 / Year
Drug Listing $ 399 / Drug
Label Review $ 649 / Drug
US FDA Drug Facility Registration & Payment Wizard
Drug Listing Form

 

 

Food (Applicable Fees)


FDA Registration and US Agent for Foreign food facility $ 349 / Year
FDA Registration for US food facility $ 149 / Facility
Food Canning Establishment Registration Assistance $ 649 / Establishment
Label Review $ 649 / Product
US FDA Food Facility Registration & Payment Wizard
Prior Notice Form

 

 


Medical Devices (Applicable Fees)


FDA Registration and U.S. Agent service $ 449 /Year
Device Listing $ 50 / Device
Label Review $ 649 / Device
FDA 510(K) Submission Click Here
US FDA Medical Facility Registration & Payment Wizard

 

 


Blood (Applicable Fees)


Establishment Registration + US Agent service $ 449 / Establishment
Product Listing $ 50 / Product
Label Review $ 649 / Device

 

 

Payments

All payments to be made to I 3 Consulting as per the details mentioned in invoice.

 

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