Regulatory Compliance Solutions for Homeopathic Products in the USA & NDC Labeler Codes

We provide complete Regulatory Compliance Solutions for Homeopathic Drug registration in the USA and sustain a compliant, competitive, and lucrative position. We assist startups and SMEs in FDA NDC Labeler Code Request Registration, US Drug Listing (DRLS), Label Compliance, Drug Facility Registration, and Renewal. Get the information and guidance to meet all regulatory compliance and obtain NDC Labeler Code from the FDA.

What Is a NDC Labeler Code?

Drugs are recognized and reported using a unique, three-segment number assigned by FDA. This three-segment number is called the National Drug Code (NDC labeler code) and serves as the FDA’s identifier for drugs. The NDC labeler code also helps consumers and compliance enforcement experts to identify medicines.

Further, NDC labeler codes identify the pharmaceutical firm, repackager, or distributor as well as Drug – Sunscreen with the active ingredient and the package type and size. Any product that has been classified as a drug and is marketed without a DIN Number does not cater to the FDA and is considered to have risks for patients.

Here from Some of Our Amazing Clients

Proven Expertise. Companies that have put their faith in us to help them become regulatory compliant.

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NHP Database
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Edward Ro Amazing Grass

“We’ve worked with Andrew and the QSS team for 5 years and they’ve always been very knowledgeable and professional. They’re a tremendous partner to have when dealing with Health Canada compliance regulations and will always work with you to come up with the best solutions.”

Michael MT Consulting

I have been working with Andrew and his team at QSS for a couple of years now. I have clients from many different parts of the world and each situation requires expertise and focus, which I’m getting from QSS. I highly recommend Andrew and QSS to any perspective client who wants to “get it right” regarding Canadian and cross border compliance.

Don Gauvreau Pharma Freak

I've used QSS services for many years now and they always deliver a very professional service. Everyone on the team is great to work with and the always come up with great solutions for your needs at a great price!

    Importance of Drug Regulatory Compliance in USA

    No drug products in USA can be sold without meeting Homeopathic Compliance Solutions. Drugs without an NDC Labeler Code mean the FDA has not reviewed them for safety and effectiveness.

    Drug Listing Act in the USA

    According to this Act, every registered Drug Establishment must provide the FDA with a list of drugs they currently manufacture, propagate, prepare, or process for commercial sale or distribution.

    NDC Directory

    The FDA publishes the listed NDC Labeler Code numbers in the NDC Directory, which has information on active and certified finished. FDA updates this directory daily.

    Homeopathic Drugs Compliance Solutions in USA

    Quick assistance at the right time to meet homeopathic drug regulations in USA. Our range of homeopathic drugs resolutions in USA include:

    NDC Registration

    Get help from former FDA officials to prepare and submit a request in SPL (Structured Product Labeling) for NDC Labeler Code registration.

    US Drug Listing (DRLS)

    Our solutions for US Drug Listing, registering your drugs and submitting required listing information for homeopathic medicines.

    US Drug Label Compliance

    We help clients adhere to US Drug Label Compliance for homeopathic medicines by making them aware of any labelling compliance changes.

    Drug Facility Registration and Renewal

    Proper assistance from us to manage your application process for establishment registration SPL, followed by submitting an application to the FDA.

    US Agent Service

    Quality Smart Solutions can work as your US Agent and respond to FDA questions, concerning your homeopathic products.

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