FDA LISTING INC: EXPERIENCED ADVISORS FOR FULL-SERVICE FDA REGISTRATION & COMPLIANCE
+1 212 444 8202
U.S. FDA Registration
& Labeling Compliance Assistance
FDA Listing Inc
Building Trust, Ensuring Compliance.
FDA Listing Inc. is a New York Corporation founded in 2018 that 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 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.
Drugs
Navigating FDA registration can be challenging. Our dedicated team is here to make it seamless for you. Whether you’re introducing a new product to the U.S. market, renewing existing registrations, or maintaining compliance with FDA standards, we’re ready to assist every step of the way.
Why Choose Us?
With extensive expertise in FDA regulatory compliance, we understand the drug industry’s unique requirements and challenges. Our team ensures your products meet all FDA standards, from establishment registration, drug listings, and Drug Master File submissions to labeling compliance. We manage every aspect of the process, including document preparation, submission, and ongoing communication with FDA officials as needed.
Drugs
Navigating FDA registration can be challenging. Our dedicated team is here to make it seamless for you. Whether you’re introducing a new product to the U.S. market, renewing existing registrations, or maintaining compliance with FDA standards, we’re ready to assist every step of the way.
Why Choose Us?
With extensive expertise in FDA regulatory compliance, we understand the drug industry’s unique requirements and challenges. Our team ensures your products meet all FDA standards, from establishment registration, drug listings, and Drug Master File submissions to labeling compliance. We manage every aspect of the process, including document preparation, submission, and ongoing communication with FDA officials as needed.
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 !
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.
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.
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.
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!
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 !
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.
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.
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.
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 !
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.
FDA Requirements for Hand Sanitizers and Other
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. The registration and listing process can take 6-8 workdays depending on how quickly you can provide the FDA-required information. Note, FDA may not need to conduct ...
Modernization of Cosmetics Regulation Act-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 will now be held accountable for providing the safety and effectiveness of cosmetic products as positive changes toward consumer safety ...
How to Renew FDA Registration?
FDA registration renewal process primarily depends on the type of products that are being marketed in the US. Here we try to break down the FDA renewal steps and fees based on the registration type. In the article below, we cover the FDA renewal steps for food, medical device, drugs and cosmetics. All food facility registrations must be renewed every ‘even year’ between October 1st, and December 31st. Regardless of when a food facility ...
National Drug Code or NDC is a 10-digit identification number assigned to each drug product in the US market (either OTC or prescription). The NDC number is primarily used for medical billing and insurance purposes, it also can be presented a proof of proper FDA drug listing. The first 5 digits of NDC code, known as labeler code, will be assigned by the FDA to the brand owner, packer and/or the manufacturer of the drug. The second 5 digits will be generated by labeler company ...
FDA Requirements for Hand Sanitizers and Other
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 ...
Modernization of Cosmetics Regulation Act-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 ...