FDA LISTING INC: EXPERIENCED ADVISORS FOR FULL-SERVICE FDA REGISTRATION & COMPLIANCE
+1 212 444 8202
U.S. FDA Registration
& Labeling Compliance Assistance
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.
OTC Drug Establishment
Registration & Drug Listing
Over-the-counter (OTC) drugs are products considered safe and effective by the FDA, yet can be purchased without a prescription.
OTC Drug
Labeling Requirements
All drugs sold in the U.S., regardless of where they are manufactured, must comply with the labeling requirements set by the FDA (FD&C Act).
FDA NDC
Labeler Code
The United States Drug Listing Act of 1972 requires registered drug establishments to provide the FDA with a current list of all drugs manufactured.
FDA Drug
Master File (DMF)
A Drug Master File (DMF) is a secure submission to the FDA that contains confidential and detailed information about facilities, processes.
FDA Registration
Certificate & US Agent
Companies registered with the FDA often seek a certificate to use as proof of registration when dealing with trade or industry partners.
FDA Import Alert
& Detention Assistance
FDA Import Alerts protect US consumers from products produced at facilities with a known history of violations. After identifying a violation.
OTC Drug Establishment
Registration & Drug Listing
Over-the-counter (OTC) drugs are products considered safe and effective by the FDA, yet can be purchased without a prescription.
OTC Drug Labeling
Requirements
All drugs sold in the U.S., regardless of where they are manufactured, must comply with the labeling requirements set by the FDA (FD&C Act).
FDA NDC
Labeler Code
The United States Drug Listing Act of 1972 requires registered drug establishments to provide the FDA with a current list of all drugs manufactured.
FDA Drug
Master File (DMF)
A Drug Master File (DMF) is a secure submission to the FDA that contains confidential and detailed information about facilities, processes.
FDA Registration
Certificate & US Agent
Companies registered with the FDA often seek a certificate to use as proof of registration when dealing with trade or industry partners.
FDA Import Alert
& Detention Assistance
FDA Import Alerts protect US consumers from products produced at facilities with a known history of violations. After identifying a violation.
Frequently Asked Questions (FAQ)
OTC (over-the-counter) drug manufacturers must register their facilities and list their drug products with the FDA.
Facilities that manufacture, repack, relabel, or distribute OTC drugs for the U.S. market must register.
Facilities must register before manufacturing or distributing products and update their registration annually.
You must provide facility details, contact information, and a list of all manufactured drug products.
OTC labels must include drug facts, active ingredients, uses, warnings, directions, and storage information.
Frequently Asked Questions (FAQ)
OTC (over-the-counter) drug manufacturers must register their facilities and list their drug products with the FDA.
Facilities that manufacture, repack, relabel, or distribute OTC drugs for the U.S. market must register.
Facilities must register before manufacturing or distributing products and update their registration annually.
You must provide facility details, contact information, and a list of all manufactured drug products.
OTC labels must include drug facts, active ingredients, uses, warnings, directions, and storage information.