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FDA Registration & FDA Certificate





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 complete FDA Registration biannual. This process is known as FDA Establishment Registration or FDA Facility 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's experts provide to clients US FDA consultants service for 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's US FDA consultants services.

Lowest FEE CHALANGE !!!

Contact us for QUICK action





 

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


Cosmetics


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

 

Drugs (Human and Animals)


  • Register Drug Facility / Establishment with US FDA
  • Request NDC Labeler Code for the Establishment
  • Assistance in assigning labeler code
  • Drug Listing with US FDA
  • SPL File preparation
  • US Agent service
  • FDA Registration Renewal and Blanket Submission

 

Food (Human and Animals)


  • Registration of Food and Dieatary Suppliement Facilities
  • LACF Registration (Acidified & Low-Acid Canned Food)
  • Dietary supplement facilities
  • Assistance with Food Label Review and Guidance
  • Food Contact Substances (FSC) Guidance, Approval and Certification
  • 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 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 for US food facility $ 349 / Facility
FCS Guidance and Compliance Certificate $ 3000
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)


US 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.

 


Contact Us for FDA Registration, Certification & Approval


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