FDA Listing Inc.

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FDA LISTING INC: EXPERIENCED ADVISORS FOR FULL-SERVICE FDA REGISTRATION & COMPLIANCE

+1 212 444 8202

FDA Listing

+1 212 444 8202

FDA Listing

U.S. FDA Registration

& Labeling Compliance Assistance

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    FDA Listing

    U.S. FDA Registration

    & Labeling Compliance Assistance

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    FDA Listing Inc

    Building Trust, Ensuring Compliance.

    FDA Listing Inc., founded in 2018 in New York, provides FDA registration and listing, labeling compliance, U.S. agent services, and FDA detention assistance to the food, cosmetics, drugs, and medical device industries.

    We bring years of experience serving global clients, combining technical competence, customer orientation, and reliability in regulatory compliance. Our commitment is to keep your confidential information safe and fulfill FDA requirements to maintain a bulletproof compliance plan, allowing you to confidently focus on your core business operations.

    FDA Listing Inc. is a New York Corporation founded in 2018 that provides FDA registration and listing, labeling compliance, U.S. agent services, and assistance with FDA detention to the food and supplements, cosmetics, pharmaceuticals, and medical device industries.

    We bring years of experience serving global clients, combining technical competence, customer orientation, and reliability in regulatory compliance. Our commitment is to keep your confidential information safe and fulfill FDA requirements to maintain a bulletproof compliance plan, allowing you to confidently focus on your core business operations.

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    Navigating FDA registration can be complex. Our specialized team is here to simplify the process for you. Whether you’re looking to bring a new product to the U.S. market, renew your existing registrations, or ensure compliance with evolving FDA standards, we’re here to help.

    Why Working with Us?

    Our team has deep expertise in understanding your industry’s unique needs and challenges in FDA regulatory compliance. We ensure that your food and supplement products meet all FDA requirements, from registration to labeling. We handle every process step, from document preparation to submission, and follow up with FDA officials when needed.

    Discover Services
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    Food & Supplements

    Navigating FDA registration can be complex. Our specialized team is here to simplify the process for you. Whether you’re looking to bring a new product to the U.S. market, renew your existing registrations, or ensure compliance with evolving FDA standards, we’re here to help.

    Why Working with Us?

    Our team has deep expertise in understanding your industry’s unique needs and challenges in FDA regulatory compliance. We ensure that your food and supplement products meet all FDA requirements, from registration to labeling. We handle every process step, from document preparation to submission, and follow up with FDA officials when needed.

    Discover Services
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    Client reviews stars

    Client Reviews

    Client Star

    Kim Oon

    We are a company in Malaysia. We export skincare products. A company approached us but with a price that is sky high and they made is sounded like the process is very complex. Thank you to Mr Mohsen for the professional service rendered. will introduce FDA Listing Inc to our government export org for sure. Fantastic Job !

    Client Star

    Gamariel

    I needed immediately assistance and I had to find a way to register with the FDA. When my company reached out to FDA Listings Inc, Mr. Monsen was ready to ease everything for us. He was very polite, professional. I definitely recommend FDA Listings Inc to anyone who’s conducting business in food, drugs, medical devices, and cosmetic. 

    Client Star

    Ascentech Solution

    We are LED Lights and Medical devices manufacturer and we wanted to register our company with the FDA. FDA listing Inc is our US agent and best service provider, In the whole process we stuck at various points but Mason helps us every time. He helped us without caring the timings difference between India and US. We had a wonderful experience with him.

    Client Star

    Pierluigi Folcarelli

    For the company I work for, export to the US has always been of critical importance. When I started dealing with FDA-related issues, I sought help online, and I discovered FDA Listing Inc. Worth of mention was Mr. Mason, who assisted and taught me a lot about FDA. I would therefore strongly advise anyone in need for help with FDA, to contact them.

    Client Star

    Malka Livingston

    Our US company, for MedShield Products, is so grateful to FDA Listing Inc for all their help with our sanitizer OTC listing. They are extremely professional with super speed responses to all our questions. They made the process simple and the personnel is so pleasant to work with. We had the pleasure of working with Mohsan, and he is amazing!

    Client Star

    Kim Oon

    We are a company in Malaysia. We export skincare products. A company approached us but with a price that is sky high and they made is sounded like the process is very complex. Thank you to Mr Mohsen for the professional service rendered. will introduce FDA Listing Inc to our government export org for sure. Fantastic Job !

    Client Star

    Gamariel

    I needed immediately assistance and I had to find a way to register with the FDA. When my company reached out to FDA Listings Inc, Mr. Monsen was ready to ease everything for us. He was very polite, professional. I definitely recommend FDA Listings Inc to anyone who’s conducting business in food, drugs, medical devices, and cosmetic. 

    Client Star

    Ascentech Solution

    We are LED Lights and Medical devices manufacturer and we wanted to register our company with the FDA. FDA listing Inc is our US agent and best service provider, In the whole process we stuck at various points but Mason helps us every time. He helped us without caring the timings difference between India and US. We had a wonderful experience with him.

    Client Star

    Pierluigi Folcarelli

    For the company I work for, export to the US has always been of critical importance. When I started dealing with FDA-related issues, I sought help online, and I discovered FDA Listing Inc. Worth of mention was Mr. Mason, who assisted and taught me a lot about FDA. I would therefore strongly advise anyone in need for help with FDA, to contact them.

    Client Star

    Kim Oon

    We are a company in Malaysia. We export skincare products. A company approached us but with a price that is sky high and they made is sounded like the process is very complex. Thank you to Mr Mohsen for the professional service rendered. will introduce FDA Listing Inc to our government export org for sure. Fantastic Job !

    Client Star

    Gamariel

    I needed immediately assistance and I had to find a way to register with the FDA. When my company reached out to FDA Listings Inc, Mr. Monsen was ready to ease everything for us. He was very polite, professional. I definitely recommend FDA Listings Inc to anyone who’s conducting business in food, drugs, medical devices, and cosmetic. 

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    Blog Posts
    Understanding the FDA’s Drug Amount Reporting Requirements
    Understanding the FDA’s Drug Amount Reporting Requirements The U.S. FDA has released updated guidance on reporting the amount of listed drugs and biological products under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This requirement, introduced under the CARES Act, aims to enhance the FDA’s ability to assess, prevent, and mitigate potential drug shortages by improving...
    Modernization of Cosmetics Regulation Act-MoCRA
    Modernization of Cosmetics Regulation Act-MoCRA FDA Modernization of Cosmetics Regulation Act of 2022 – MoCRA The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) has finally been signed into law by the U.S. Food and Drug Administration (FDA). This legislation will bring much-needed regulatory oversight to the cosmetic industry, ensuring the safety and well-being of consumers. Companies...
    FDA Homeopathic Registration: What You Need to Know
    FDA Homeopathic Registration: What You Need to Know What is a Homeopathic Drug? Homeopathy is an alternative medicine that has experienced a significant surge in popularity in recent years. This has contributed to the growth of the US homeopathic market, which is estimated to be a $3 billion industry. Homeopathic products are typically derived from various natural sources, including plants, minerals,...
    How to obtain NDC number?
    How to obtain NDC number? What is NDC number? The National Drug Code (NDC) is a unique, 10-digit identification number assigned to every drug product in the U.S. market, whether over-the-counter (OTC) or prescription. The NDC serves several vital purposes, including its primary use in medical billing and insurance claims processing. It is also an essential piece of documentation for proving a drug’s...
    Medical Devices; Who Must Register List and Pay the Fee
    Medical Devices; Who Must Register List and Pay the Fee Establishments that are involved in the production and distribution of medical devices intended for commercial distribution in the U.S., including those that are imported for export only, are required to register annually with the FDA. Most establishments that are required to register are also required to list the devices and the activities performed...
    FDA Requirements for Hand Sanitizers and Other Antiseptic OTC Drugs
    FDA Requirements for Hand Sanitizers and Other Antiseptic OTC Drugs Hand Sanitizers and most form of antiseptic/antibacterial products are considered over-the-counter (OTC) drugs by the FDA. In order to introduce an OTC drug to the U.S. market, the manufacturers  must fulfill certain FDA requirements that are summarized below. OTC Drug Manufacturers: Follow the relevant OTC monograph published by the...
    Understanding the FDA’s Drug Amount Reporting Requirements
    Understanding the FDA’s Drug Amount Reporting Requirements The U.S. FDA has released updated guidance on reporting the amount of listed drugs and biological products under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This requirement, introduced under the CARES Act, aims to enhance the FDA’s ability to assess, prevent, and mitigate potential drug shortages by improving...
    Modernization of Cosmetics Regulation Act-MoCRA
    Modernization of Cosmetics Regulation Act-MoCRA FDA Modernization of Cosmetics Regulation Act of 2022 – MoCRA The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) has finally been signed into law by the U.S. Food and Drug Administration (FDA). This legislation will bring much-needed regulatory oversight to the cosmetic industry, ensuring the safety and well-being of consumers. Companies...
    FDA Homeopathic Registration: What You Need to Know
    FDA Homeopathic Registration: What You Need to Know What is a Homeopathic Drug? Homeopathy is an alternative medicine that has experienced a significant surge in popularity in recent years. This has contributed to the growth of the US homeopathic market, which is estimated to be a $3 billion industry. Homeopathic products are typically derived from various natural sources, including plants, minerals,...
    How to obtain NDC number?
    How to obtain NDC number? What is NDC number? The National Drug Code (NDC) is a unique, 10-digit identification number assigned to every drug product in the U.S. market, whether over-the-counter (OTC) or prescription. The NDC serves several vital purposes, including its primary use in medical billing and insurance claims processing. It is also an essential piece of documentation for proving a drug’s...
    Medical Devices; Who Must Register List and Pay the Fee
    Medical Devices; Who Must Register List and Pay the Fee Establishments that are involved in the production and distribution of medical devices intended for commercial distribution in the U.S., including those that are imported for export only, are required to register annually with the FDA. Most establishments that are required to register are also required to list the devices and the activities performed...
    FDA Requirements for Hand Sanitizers and Other Antiseptic OTC Drugs
    FDA Requirements for Hand Sanitizers and Other Antiseptic OTC Drugs Hand Sanitizers and most form of antiseptic/antibacterial products are considered over-the-counter (OTC) drugs by the FDA. In order to introduce an OTC drug to the U.S. market, the manufacturers  must fulfill certain FDA requirements that are summarized below. OTC Drug Manufacturers: Follow the relevant OTC monograph published by the...

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