OTC Drug Compliance Solutions in Canada and USA

Get complete OTC Drug Compliance Solutions, such as DIN registration (Canada), PLL Compliance, NDC Registration (USA), Drug Label Compliance, Drug Facility Registration and Renewal, and more. 

Over-The-Counter (OTC) Drugs in Canada and USA

Drug categories include over-the-counter (OTC), Prescription drugs, Radiopharmaceuticals, Biologics, and Gene Therapies. OTC Drugs, which is also called non-prescription drugs, are health products that are sold in the Canadian and USA market and can be bought without a medical prescription.  These drugs are safe and effective for use. 

Health Canada regulates OTC drugs to ensure they are safe to use and reduce health risks to Canadians. In USA, FDA conducts a regulatory review of OTC drugs based on active pharmaceutical ingredients and labeling not by assessing individual drug formulations. There are almost 300,000 OTC drug products in the US market.

Here from Some of Our Amazing Clients

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

Shams W.Pawel 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.

Donal Gauvreau Sapro

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 OTC Drug Compliance Solutions

OTC Drugs to be sold in Canada require a Drug Identification Number (DIN). This number on a product label indicates the drug has met all requirements for quality, safety, and effectiveness. Canadian firms that are engaged in manufacturing, packaging, labeling, and importing non-prescription drugs must be licensed for these activities. Similarly, any company intending to produce OTCs in USA is required to ensure that their product meets the standards for safety and efficacy. They should ensure whether they are compliant with GMPs and meet the labeling requirements as set out in 21 CFR part 201.66. The process of meeting the requirements of Health Canada and FDA can be complex in many cases.  Let Quality Smart Solutions help you prepare your OTC application accurately and efficiently.

drug identification din number
Monograph Categories

There are several monograph categories for OTC Drugs in Canada, such as Labeling Standard, TPD Category IV, and NSAIDs. Meeting their requirements is difficult.

Regulatory Pathways

To market OTC drugs in USA, you need to go through two Regulatory Pathways, OTC Drug Monograph Application Process and the OTC New Drug Application (NDA) process.

Good Manufacturing Practices

Any firm (domestic or foreign) manufacturing, distributing, or importing OTD drugs require to show evidence that they are following GMP.

Establishment License

To manufacture, sell, or import non-prescription drugs, businesses must obtain an establishment license.

Product Types we have Licenced

Only applies to NHP, medical devices, dietary supplements, vet health product

Sports Nutrition
Hand Sanitizers
Multi Vitamins
Super Green Health Products
Energy Boost Products

Turnkey Solutions for OTC Drug Compliance in Canada

Our Canadian OTC Regulatory Experts are backed with extensive knowledge and years of experience. We offer OTC compliance consulting services for all types of companies to lessen regulatory risk and assure a speedy way for the launch of your OTC drug. 

Drug Identification Number (DIN) Registration

With more than a decade of experience, we will help you by reviewing complete drug application requirements and preparing your application to apply for and receive a Direct Identification Number from Health Canada.

Health Canada Pre-Submission Meeting

Former Health Canada officers will guide you on how to submit a meeting request, prepare for discussion as well as attend meetings with you to offer support with Health Canada officials.

Plain Language Labelling Compliance & French Translation

Worried about Plain Language Labeling (PLL) compliance and French Translation? Don't worry. We ensure your drug application will meet language requirements and contain the PLL format label when submitted.

Establishment License (EL) Registration

Wondering how to get an Establishment License? Avail from us complete support to register your facility for an Establishment License along with annexing foreign sites to Canadian import license holders.

OTC Drug Compliance Solutions in USA

At Quality Smart Solutions, we have the capability to offer assistance in all phases of the drug facility registration, drug development cycle, such as business planning, product development, meeting USA drug label compliance, and more.

National Drug Code Labeler Code (NDC) Registration

We offer complete solutions to obtain NCD Labeler Code, such as preparing and submitting a request in SPL (Structured Product Labeling) format via FDA's Electronic Submission Gateway or ESG.

US Drug Listing (DRLS)

Our OTC Drugs specialists in USA will assist you in registering your OTC drugs and submitting required listing information for all drugs in commercial sales and distribution before the deadline.

US Drug Label Compliance

We provide proper help with guaranteed service which includes pre-approval label reviews or label development. We'll guide you on changes to labeling to ensure compliance with US Drug Label requirements

Drug Facility Registration and Renewal

We will prepare application for establishment registration SPL on behalf of your company and submit to the FDA through ESG gateway. We will also help in the renewal process of your facility.

US Agent Service

We are certified as US Agent for non-US companies. We can respond to every question from FDA, help you during meetings with FDA officials, receive all important documents, and provide the same to you.

Featured Insights


US Establishment Registration Renewals

It’s that time of year again! Any domestic and foreign establishments registered with US FDA must renew their registration annually between October 1st and December

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