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US Compliance Solutions for Homeopathic Medicines

We provide complete regulatory compliance solutions for homeopathic medicines in the USA. 

We assist startups and existing companies with FDA NDC Labeler Code Requests, US Drug Listing (DRLS), Label Compliance, Drug Facility Registration and Annual Registration Renewal. Get the information and guidance you need to meet all regulatory requirements and obtain NDC labeler codes for your drug products.

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What is an NDC Labeler Code?

Drugs are recognized and reported using a unique, three-segment number assigned by the 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 sold in the USA.

Further, NDC labeler codes identify the pharmaceutical firm, repackager, or distributor as well as the type of drug product with the active ingredient and the package type and size. Any product that has been classified as a drug and is marketed without an NDC does not cater to the FDA’s requirements and is considered to pose a risk to consumers/patients.

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Proven Expertise. Companies that have put their faith in us to help them comply with the regulations.

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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 the USA

No drug products, including homeopathic medicines, in the USA can be sold without meeting the applicable drug product regulations. 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 drug products. The FDA updates this directory daily.

Homeopathic Drug Compliance Solutions for the USA

We provide quick assistance at the right time to help you meet homeopathic drug regulations in the USA. Our range of homeopathic drug compliance solutions for the USA includes:  We help clients adhere to US Drug Label Regulations for homeopathic medicines by making them aware of any labelling requirements and changes. We provide assistance with managing your establishment registrations, followed by submitting an application to the FDA.

NDC Registration

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

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US Drug Listing (DRLS)

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

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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.

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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.

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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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Quality Smart Solutions is a global consulting firm, engaged in providing strategic support for products including NHPs, pharmaceuticals, and medical devices, in areas such as Regulatory Support, Site Licensing, Clinical Development and more.

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