FDA 510(k) Pre-Submission: Steps for Medical Device Approval
Are you trying to make sense of the FDA’s 510(k) pre-submission process? You’re not alone. Many companies, especially those new to the regulatory landscape, find
... Read moreBecome compliant with food and beverage regulations in Canada and USA with expert assistance from Quality Smart Solutions. We help you with training, product classification, auditing, and safety & quality measures.
The food and beverage industry contains online sale of packages and fresh foods (not baby food), delicacies, and beverages. It includes sale of vegetables, fruit, snacks, pasta, refrigerated products, soft drinks, frozen food, alcoholic drinks, etc. Online shops, large supermarkets, and warehouse stores are the most significant channel for the online sale of food and beverage.
Food & Beverage is the second largest industry in Canada when it comes to production value. It is more than 16% of total manufacturing sales, contributing 2% of the national GDP. In USA, the food and beverage industry has been projected to reach US$18,702m in 2020.
Proven Expertise. Companies who have Trusted Us to Become Regulatory Compliant with Health Canada
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.
Health Canada monitors non-health and safety regulations related to food packaging, labelling, and advertising in Canada. FDA in USA regulates all foods and food ingredients for sale except poultry, meat, and certain processed egg products. Failure to meet agencies’ regulatory compliance will lead to heavy penalties. Your products may be banned from sale in the traditional or online market. To ensure that your products comply with Health Canada and FDA’s regulations, you must develop foods with enhanced nutritional value, nutrient information in a standardized format, and meet label compliance. Some regulatory requirements are specific to certain food products, such as seafood, low-acid canned food, or juice whereas other requirements apply to all food businesses.
Food Directorate division supervised by Health Canada is accountable for the safety and nutritional information for conventional and supplemented foods.
Providing nutritional information such as calories, serving size, percent daily value (% DV) of foods, and including the listing of 13 nutrients is mandatory.
FDA asks food manufacturers, packers, processors, distributors for certain records to identify all food products handled by them are safe and healthy for use.
Registering with FDA is mandatory even before beginning any activities if you manufacture, pack, process or stock food for human or animal consumption in USA.
Leverage our expertise in Food and Beverage Compliance in Canada and take your food from your company to consumers. Our range of compliance solutions include auditing, training, product classification, ingredient assessment, and more.
Having reviewed labels for various foods like cereals, canned goods, beverages, meats, dry products, etc., we prepare nutrient profiles based on the Nutrition Facts Table to qualify nutrient claims.
We calculate nutrients and create a print-ready, bilingual nutrition facts table as per the compendium of Nutrition Facts table and the new Nutrition Facts table format that will be required by 2021.
Don't worry if your products do not meet the Canadian Food and Drug Regulations (FDR). We will help you acquire temporary market authorization (TMA) License and allow marketing of your food.
Want help in preparing Novel Food Additive Application for your new food ingredient, right? Don’t worry. We’ll help you prepare the novel food additive application and submit to the concerned authority.
Do you have your SFCR License? If not, get quick help from us to apply for Safe Food For Canadians Regulations (SFCR) License if you manufacture, import, export, and trade food products.
Wondering if a HACCP or PCP program is right for you? We create a list of tasks before setting up a HACCP plan for your food-related business to prevent problems and plan a way to assure food safety.
Obtain a License under the new Safe Food for Canadians Regulations with our help and grow your business of manufacturing, processing, preserving, packaging, labelling, importing or exporting foods.
Our range of food and beverage compliance solutions in USA empowers you to implement safety and quality measures and meet labeling compliance. Below are our services related to the Food and Beverage Industry in USA.
We guarantee your labels comply with new FDA food regulations by preparing a print-ready and future-proof Nutrition Facts Panel and designing print-ready full-compliant artfile (logo, brand images).
Our experts will help you create Nutrition Facts Panel either by using raw material certificates of analysis and ingredient information or utilizing your raw, unrounded, per 100 grams Nutritionals.
If you deal with manufacturing, processing, packaging, or holding foods, we will assist you in registering your food facility with FDA or renew your current registration to avoid any late fee.
We review your food ingredients and check whether GRAS is possible, then prepare a well-organized, detailed GRAS dossier, submit it to FDA to ensure your ingredient qualifies for sale in USA.
Avail assistance from our FDA compliance professionals in preparing a self-affirmed GRAS dossier and ensure your ingredient adheres to the safety qualifications for sale in USA.
Are you trying to make sense of the FDA’s 510(k) pre-submission process? You’re not alone. Many companies, especially those new to the regulatory landscape, find
... Read moreAre you ready to introduce your infant formula to the Canadian market? Health Canada’s stringent regulations ensure the safety, quality, and nutritional adequacy of all
... Read moreHealth Canada Opens 75-Day Consultation on Batch 4b – Share Your Input The Natural and Non-Prescription Health Products Directorate (NNHPD) invites industry stakeholders to provide
... Read moreIntroduction Preparing for an FDA audit can be challenging, especially for dietary supplement manufacturers who must meet stringent Good Manufacturing Practices (GMP) requirements. The FDA
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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.