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US FDA Registration in India

US FDA Registration is mandated by the united states food and drug administration department. I3CGlobal and its affiliated offices in Australia, Germany, India, Malaysia, South Korea, Thailand, USA, UK, and Vietnam provide US FDA registration services from their respective locations. We have assisted over 4000 clients in registering their establishments  in the United States since 2000, and we are glad to state that all of our customers have been success in registering without any difficulties. Our success percentage is one hundred percent.

EXPERT ADVICE

Expert US FDA advice and guidance are necessary for foreign manufacturers and exporters to ensure the smooth release of goods from US port of entry

ECONOMY PRICING

All FDA Regulatory services are priced in advance. During the agreement term, there was no further charge for minor corrections and revisions.

FAST PROCESSING
We have set timetables for all FDA services, and we diligently stick to them for our consumers. 
We understand our clients’ requirements!

US FDA Registration

(for Manufactures, Private label Distributors, Re-packers, Exporters & Initial Importers)

US FDA Registration is mandated by the united states food and drug administration department, responsible for monitoring and protecting public health from inferior quality consumer products such as drugs, medical devices, food, and cosmetics.

 

Appointing us as FDA Agent can avoid conflicts when you work with multiple distributors, Importers, and agents. We assure permanent FDA compliance with regulations over the period, no matter your relationship with distributors and importers in the USA.

 

Every company that makes a product for sale in the USA is required by law to register with the FDA. This assures that all items sold in the United States meet a set of quality criteria. Registration benefits both consumers and companies. Those register with the FDA are eligible for a variety of marketting advantages that might help them boost their overall business and exports to USA as well as other countries.

US FDA Registration Process

(Drugs, Food & Dietary Supplements, Medical Devices, Cosmetics)

All facilities involved in the processing of food, drugs, medical devices, and cosmetics for sale in USA, must complete the FDA registration & approval. The requirements are from the U.S. Food and Drug Administration. Failure to register will prevent entering the US market. All foreign facilities must name a US Agent when registering the facilities. The FDA Registration Process may feel intimidating, so we’re here to help you know exactly what you need to do to make the process go smoothly.

US FDA Registration in India and other International destinations

(We’ve helped 100+ companies to get FDA Certificate, and we want to help yours too!)

Every year, hundreds of businesses in the United States are required to register their goods with the Food and Drug Administration. It’s a massive endeavour, and it’s frequently a cause of uncertainty and irritation for enterprises seeking to break into a highly regulated field.

 

I3CGLOBAL works with the FDA from our offices in Australia, Germany, India, Malaysia, South Korea, Thailand, the United States, the United Kingdom, and Vietnam to assist you speed the process of having your facilities registered. You can relax knowing that your firm is in compliance with all applicable legislation and that you’re receiving the same high-quality service that you’d expect from a company based in your own country.

 

I3CGLOBAL is your one-stop shop for registering your facility and listing goods in the United States, with over twenty-two years of expertise in US FDA Registration. We’ll assist you in navigating the FDA’s complicated regulatory standards to ensure that your products are given a fair shake. We’re dedicated to providing you with exceptional customer service, and we have the reviews to prove it.

Industries We Serve

We serve the below industries and related products from manufactures and brand owners 

Attention – Manufacturers, Exporters, Distributors & Importers of food items for sale in USA.

 

The following type of products only can be registered.

 

  1. Human & Animal food for consumption
  2. Food Supplements or Nutraceuticals
  3. Food Ingredients
  4. Acidified & Canned foods
  5. Organic Certified Food products

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Voluntary Cosmetic Registration Program (VCRP)

 

  1. Registration for Cosmetics can be processed only if the cosmetics are already available in the USA.
  2. FDA Registration is Voluntary. The regulation is called Voluntary Cosmetic Registration Program. VCRP can be applied by the manufacturer of the cosmetic product and the brand owner.

The following type of establishments must complete FDA Registration and list the drugs

 

  1. Over-the-counter Drug manufacturers and exporters.
  2. ANDA/NDA approved drug product manufacturers.
  3. Active Pharmaceutical ingredient (API) manufacturers and exporters.
  4. Medicated cosmetics manufacturers and exporters.
  5. Analytical Test facilities.
  6. Biologicals.

 

Drug Establishment Regisatrtion Fee

 

We help manufacturers planning to export Over-the-counter (OTC) drugs. These products are generally safe and classified under ‘Generally Recognized as Safe and Effective (GRASE). No additional requirements are other than Establishment Registration, NDC, and Listing. DUNS Number is mandatory to proceed with FDA Drug Establishment Registration.

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US FDA Registration for Medical Device(s) can be initiated for:

 

  1. Direct FDA Registration is permitted only for 510(k) exempted devices.
  2. 510(k) non-exempted devices can be registered only after FDA 510(k)

 

Medical Device Name, Device FDA Code, FDA regulation Number, Class of the device, Intended use, the propitiatory name are required for completing the registration process.

Frequently Asked Questions

How to get FDA certificate?

The Food and Drug Administration (FDA) is the government agency in charge of regulating food, drugs, and medical devices. The agency was created to ensure products are safe for public consumption.

 

Before bringing a drug to market, manufacturers must conduct lab, animal, and human clinical testing and submit their data to FDA. After reviewing a manufacturer’s data, FDA may decide that the product is safe for public use. If FDA deems it necessary, they will require further tests before approving the product.

 

If you’re looking to bring a new drug to market or sell a medical device that hasn’t been approved by FDA, reach out to us! We have years of experience getting FDA approval for products.

Benefits of FDA Registration?

Consumer confidence: When your customers see that you’re registered with the FDA, they will trust you more because they know you’re committed to producing safe and high-quality products.

 

Better brand image: When you’re registered with the FDA, it gives your business an air of legitimacy and increases your visibility as a trustworthy business. Your customers will know you adhere to high standards and will trust you more as a result.

 

Product safety: The FDA has strict policies in place to ensure product safety throughout every stage of production. This helps protect consumers from unsafe products entering into markets where

 

When your customers see that you’re registered with the FDA, they will trust you more because they know you’re committed to producing high-quality and safe products.

What is the FDA Registration number?

FDA Registration number provided by FDA soon after the confirmation of registration. This is applicable to Food, drugs, cosmetics, and medical devices.

What is the difference between FDA and FDA Registered?

FDA approves only prescription drugs, research formulas, critical medical devices only. There is no FDA approved drug database for the public.

How do you find if a product is FDA Approved?

FDA approves only prescription drugs, research formulas, critical medical devices only. There is no FDA approved drug database for the public.

How much is FDA approval?

The cost and timeline for FDA approval depend on the product and nature of the product.

Does Tea need FDA approval?

Tea falls under the food category. No approval required. Register the facility and comply with labeling requirements and start marketing in America.

How do I verify FDA certification?

FDA will not issue FDA certificate.

How do I find my FDA number?

FDA number and registration details can be verified

  • Medical Device:
  • Drug Establishments:
  • Drug Labels:

How long FDA approval takes?

FDA approval depends on the product and nature of the product and its intended use.

Does my product need FDA approval?

If the medical device falls under high risk, 510k approval is required or any generic /prescription drugs need approval or certain food /pharma color additives to need approval.

How to verify my facility needs FDA approval or FDA registration?

In case of Medical Devices based on the classification and device FDA code or in the case of Drugs if not covered in monograph you can understand prior approval is required or not!