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US -FDA registration fees 32,000/- for Food Facility Registration

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US -FDA registration fees 32,000/- for Food Facility Registration

Kosher Certification India is providing the US FDA agent and registration Service for, Indian Asian client

Especia FDA Compliance is a USA based regulatory affairs consulting firm established in 2015. It has its word wide reach with offices in London, India, and Israel. Being a reputed regulatory firm allowing the quality product to reach the market is our motto and assisting our partners with best-in-class services is our commitment.

The safety of consumers around the world is vital for us, and our expert team of safety consultants ensures that by providing quality resources and solutions to each of our clients. Our FDA agents pay special attention to each company and provide them with all the necessary information and solutions to get FDA certification Fee 32,000/-. We don't compromise with our client's confidentiality and the quality of the service we provide, as both of them are our top priority.

US FDA registration is mandatory for companies that manufacture or commercialize food products, drugs and API, and medicinal devices in the USA. FDA approval Fee 32,000/is required to place their product on the market. The FDA certificate Fee 32,000/consists of a registration number that allows you to establish your genuine identity as a supplier to the USA.

As per the U.S. Food and Drug Administration (FDA) who are liable to register with the FDA?

  • Companies that are involved in manufacturing, processing, or packaging of food, beverage, or dietary supplements that are sold or exported to the US are liable for FDA registration.
  • FDA approval is mandatory for Manufacturers or distributors of medicinal devices who want to sell or export their products in the US.
  • Registration is not mandatory for Cosmetic establishments that are manufacturers, packers, or distributors of cosmetics. They can register their cosmetic establishment under FDA and take part in the Voluntary cosmetic registration program (VCRP).

Perks of our US FDA Agent Services

  • Well reputed and established regulatory firm with years of experience.
  • We provide the lowest FDA registration fees Fee 32,000/
  • Transparent service with no hidden charges.
  • Our US FDA agent service comes with food facility registration and medical device registration and listing with no additional cost.
  • Our services are under one roof, which makes it convenient for our clients.
  • Client confidentiality is our top priority

What we provide under our services

Especia FDA compliance provides FDA registration and FDA certification for three main industries.

Food Industry

Establishments that manufacture, process, pack, or hold food, beverage and dietary supplements for consumption in the United States must register under FDA according to United States Food and Drug Administration FDA. Our company provides FDA food facility registration and US FDA registration renewal guideline and consultancy.

Medical devices Industry

US Food and Drug Administration has strict guidelines for manufacturers and distributors of medical devices. Especia FDA provides expert FDA consulting for medical device registration and listing. Our company helps our client to register their devices at the lowest fees possible with the annual renewal of existing device listing information.

Cosmetic industry

Our company provides the best FDA cosmetic registration and expert US FDA agent service at an affordable cost. We monitor and fulfil the unique needs of our cosmetic establishments involved in the manufacturing or packaging of cosmetic products for commercial use. It is very easy to get Cosmetic Product Ingredient Statements (CPIS) certificates with us.

 

FOOD

About US FDA Food Facility Registration

Facilities that handle manufacturing, marketing, processing, and holding or storage of food materials, beverages, and dietary supplements in the US must take FDA registration Under United States Food and Drug Administration FDA. For countries that are outside of the USA, want to take FDA registration in the US must assign an FDA agent. The U.S FDA agent will become the bridge between the FDA and the foreign company and provide the primary point of contact.

Why should you hire a US FDA Agent?

Food and Drug Administration and their rules and regulations are a very sensitive matter of interest, and FDA approval is a very time-sensitive matter. Assigning a US FDA agent who understands all the rules and regulations of the Food and Drug Administration make the registration process quite easy. An expert agent will speak with the FDA on behalf of a foreign company and give advice on FDA guidelines that must be followed. On addition, they will be aware you about the rules and regulation of the FDA and prevent a possible mistake that can cause rejection from the US FDA.

Especia FDA Compliance provides expert agents that will help foreign countries to get FDA food and facility registration and enter in US market, all at the lowest price. We also renew the registration for establishments that already FDA registered.

What is the process of FDA Food Facility registration?

  • Company information (facility name, full address, phone number, and other vital information) and product information should be proper.
  • Reach out to our website and appoint a US FDA agent.
  • Fill the FDA food and facility registration form and submit it (online/ offline both methods available).
  • After verifying all the information, the US FDA will issue an 11-digit FDA number.
  • Especia Compliance will issue the FDA certificate.

 

What is the FDA Registration certificate?

The FDA registration certificate is the proof for your establishments FDA approval and US custom, importers, and distributors will use the certificate to give you clearance for doing business in US territory. After the successful FDA registration, the US Food and Drug Administration will issue an 11-digit registration number unique to your company. However, the US FDA does not issue any certificate; a third party farm does it. Especia Compliance will guide you through the registration process and provide you with an FDA certificate which will assist you in the customs clearance process.

Why should we fill shipment prior notice with FDA?

Before the arrival of the shipment of food, the US FDA requires a prior notice about the food shipment. The notice includes all information about the product, its quantity, what type of packaging is used, details about the company/ facility, and a sample of the food product. US FDA examines and verifies all the conditions and after successful verification issue a confirmation number. The confirmation number is given to the US customs broker to release the shipment. International transit firms and shipment companies handle the process of prior notice.

 

MEDICAL DEVICE

About Medical Device FDA registration

US FDA has regulations and guidelines for Companies that are involved in medical device business such as; Manufacturing, developing or assembling, packing, labelling, import or export should be registered under the FDA. The FDA registered device establishments are requiring to maintain a product or medical device list, which includes every detail about individual devices. This FDA device list should be provided to the US Food and Drug Administration before the commercial distribution in the US market. For foreign companies, assigning a US FDA agent is a must. Companies outside the US are required to hire an FDA agent for the initial point of contact for the US FDA and prevent any discrepancy in the process. The FDA device establishment registration annual fees for 2021 is 5,546 USD.

An FDA agent is very important for companies that are doing business in the US from a foreign country as the agent will become a bridge between the US FDA and the foreign company and reduce the chance of any miscommunication, time delay, or violation of rules and regulations. As time is everything in business, we recommend hearing an expert agent for your establishment.

Our company provides not only medical device establishment registration under Food and Drug Administration but also provides medical device listing service to foreign companies. Our expert team is available 24x7 for your help and provide experienced FDA agents for Non-US companies. Especia Compliances provides all of this under one roof at affordable pricing.

What is the process of FDA medical device establishment registration?

  • Company information (facility name, full address, phone number, and other vital information) and product information should be proper.
  • Reach out to our website and appoint a US FDA agent.
  • Fill the FDA medical device establishment registration form and submit it (online/ offline both methods available).
  • After verifying all the information, the US FDA will issue an 11-digit FDA number.
  • Especia Compliance will issue the FDA certificate.

What is the FDA medical device establishment registration certificate?

After verification of all the provided information, the US FDA completes the registration and the concerning medical device company will be provided with a registration number. The registration number unique to your company, but the US FDA does not issue any certificate; a third party farm does it. The FDA registration certificate is the proof for your establishments FDA approval and US custom, importers, and distributers will use the certificate to give you clearance for doing business in US territory. Especia Compliance will guide you through the registration process and provide you with an FDA certificate which will assist you in the customs clearance process.

COSMETIC

About Cosmetic FDA registration

Registration is not mandatory for Cosmetic establishments that are manufacturers, packers, or distributors of cosmetics. They can register their cosmetic establishment under FDA and take part in the Voluntary cosmetic registration program (VCRP), which is a post-market reporting system. However, FDA registration is mandatory for cosmetic colour additives. Still, cosmetic companies should follow all FDA guidelines and use only those ingredients to manufacture their product, that is safe for consumers with proper labelling.

Especia FDA compliance guides cosmetic establishments through the FDA cosmetic manufacturing establishment registration process. Our company provides expert FDA agents to help Non-US cosmetic manufacturers of packers to do their business properly by following all the US FDA rules and regulations. An FDA agent bridges the gap between the foreign company and US FDA for smooth and easy operation. We also provide an FDA listing service for individual cosmetic products in a cosmetic establishment, also known as Cosmetic Product Ingredient Statements (CPIS).

The use of FDA registration certificate

The FDA registration certificate is the proof for your establishments FDA approval and US custom, importers, distributers will use the certificate to give you clearance for doing business in US territory. After the successful FDA registration, the US Food and Drug Administration will issue an 11-digit registration number unique to your company. However, the US FDA does not issue any certificate; it is done by a third party farm. Especia Compliance will guide you through the registration process and provide you with an FDA certificate which will assist you in the customs clearance process.