Compliance Solutions for Homeopathic Sector in Canada and USA

We assist startups and SMEs with compliance solutions in HM-DIN Registration in Canada and Homeopathic Drug registration in USA, thereby empowering them to sustain a compliant, competitive, and lucrative position. 

What Is ‘HM-DIN’ and ‘NDC?’

HM-DIN – Homeopathic medicines are licensed as DIN-HM in Canada. DIN (Drug Identification Number) is a number issued by Health Canada to a drug product to be sold in Canada. The number identifies all drug products sold in dosage and is located on the label of prescription drug products that have been evaluated and authorized for sale in Canada. Having this number is mandatory to sell your homeopathic medicines.

NDC – NDC (National Drug Code) is a unique three-segment number assigned by FDA. It serves as a universal product identifier for drugs and helps consumers and compliance/enforcement professionals to identify product medicine.  The number also identifies the pharmaceutical firm/repackager, or distributor/, the Drug – Sunscreen with the active ingredient and the package type and size.

fda labeler code

More than 6000 Licenses Successfully Delivered

Proven Expertise. Companies who have Trusted Us to Become Regulatory Compliant with Health Canada

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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!

Why the Need for Drug Regulatory Compliance in Canada and USA?

No drug products in Canada or USA are permitted to be sold without meeting Homeopathic Compliance Solutions. In case, a product that is classified as a drug under the Food and Drugs Act and is marketed without a DIN  does not comply with the Health Canada regulations. Similarly, in USA, drugs without NDC are thought to have significant risks to patients, because they have not been reviewed by the FDA for effectiveness, safety and quality. Having HM-DIN in Canada and NDC in USA let patients know that the drugs have been manufactured in a way that guarantees the quality of the product or whether their label is complete and accurate.

fda ndc labeler code request
Drug Listing Act in USA

This Act requires registered drug establishments to provide FDA with a current list of all drugs manufactured, propagated, prepared, compounded, or processed by it for commercial sale or distribution.

Drug Identification

Drug products in USA are identified and reported using the National Drug Code.

Homeopathic Medicines Criteria

In Canada, the Medicinal ingredient must be found in the homeopathic monograph and one of the homeopathic pharmacopeia such as the Homeopathic Pharmacopeia of HPUS, European Pharmacopeia (Ph. Eur) among others.

Canadian labelling laws

Homeopathic medicine labels must be bilingual i.e. both in English and in French because these languages are considered official in Canada.

Homeopathic Drugs Compliance Solutions in Canada

Our Canadian homeopathic compliance experts provide turnkey solutions to meet regulatory compliance.

HM-DIN Registration

We'll help you in licensing for non-specific health claim based HM-DINs class 1 NHP process and licensing for specific health claims class 3 NHP licensing process and documentation for submission.

HM-DIN Package Compliance and French Translation

Worried about HM-DIN Package Compliance and French Translation? Our experts will help you meet packaging compliance by making homeopathic medicine labels bilingual (English and French) and meeting Canadian labelling laws.

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 full-services to register NDC Labeler Code. Our experts will help you prepare and submit a request in SPL (Structured Product Labeling) for NDC registration.

US Drug Listing (DRLS)

We’ll help you in US Drug Listing and registering your drugs and submitting required listing information for all homeopathic medicines.

US Drug Label Compliance

Leverage our expertise to meet US Drug Label Compliance for homeopathic medicines and be aware of changes to labelling compliance.

Drug Facility Registration and Renewal

We will help you in the application process for establishment registration SPL and submitting to the FDA through ESG gateway.

US Agent Service

Get in touch with us as we will work as your US Agent and respond to FDA questions. We will also help you during meetings with FDA officials.

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