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.
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.
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.
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.
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.
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.
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.
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.
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
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.
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.
Health Canada is asking for your input on new draft guidance for co-packaged drug products. Participate now to help shape future compliance expectations.
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The FDA plans to extend the Food Traceability Rule compliance date by 30 months. Find out how this impacts your compliance strategy.
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