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.
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.
Proven Expertise. Companies who have Trusted Us to Become Regulatory Compliant with Health Canada
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.
There are several monograph categories for OTC Drugs in Canada, such as Labeling Standard, TPD Category IV, and NSAIDs. Meeting their requirements is difficult.
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.
Any firm (domestic or foreign) manufacturing, distributing, or importing OTD drugs require to show evidence that they are following GMP.
To manufacture, sell, or import non-prescription drugs, businesses must obtain an establishment license.
Only applies to NHP, medical devices, dietary supplements, vet health product
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.
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.
FDA PreCheck program aims to boost U.S. drug manufacturing. Learn how it could impact domestic pharmaceutical facilities and compliance steps.
... Read more
FDA food traceability compliance date may be extended. Learn about the August 2025 proposal, updated FAQs, and tools to prepare your business.
... Read more
Learn how to register a private label medical device with Health Canada. Follow this step-by-step guide to ensure regulatory compliance.
... Read more
FDA’s new EDT tool helps screen chemicals in food for toxicity. Learn how it supports safer food and faster evaluations.
... Read morePlease complete the form below. We will respond to you soon.
