MoCRA GMP Delayed Until October 2025: What You Need to Know
Learn about the FDA’s delay of MoCRA GMP to October 2025 and discover how cosmetic companies can prepare for compliance with MoCRA regulations.
... Read moreLeverage our expertise in food regulations, food Label compliance, nutrition facts panel creation, self-affirmed GRAS, and stay compliant with the applicable food regulations in the USA. We can be your trusted regulatory compliance partner and can help you with product classification, ingredient assessment, auditing, and safety & quality measures.
We offer services related to the Food and Beverage Industry in the USA.
We help you prepare a format that is ready to print as well as create a future-proof Nutrition Facts Panel and design print-ready full-compliant artfile ( brand images and logo).
Get assistance to register your food facility with the FDA or review your current registration and avoid any late fee. Helpful for those who manufacture, process or pack foods.
We act as your liaison between FDA and your facility related to inspection or product issues. The US Agent is a US citizen with the qualifications and experience dealing with FDA matters.
As your FSVP import agent we review your manufacturer's food safety plan, conduct a hazard analysis and have a FSVP plan managed by a former FDA inspector.
Let us review your food ingredients and check whether GRAS is possible followed by preparing a detailed GRAS dossier and submitting it to FDA to ascertain your ingredient qualifies for sale in USA.
Our FDA compliance professionals assist you in preparing a self-affirmed GRAS dossier and making sure your ingredients efficiently meet the safety qualifications for sale in USA.
Different from a standard food facility registration, we register your site where low-acid canned foods (LACF) and acidified foos (AF) are manufactured.
A former FDA inspector will check review your operations and documentation to ensure your food safety plan aligns with FDA's requirements as per FSMA.
We develop a food safety plan following the 7 principles of a HACCP plan or a preventive control plan so you are prepared for an audit or GFSI certification.
Proven Expertise. Companies that have put their trust in us to become FDA-compliant.
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.
The US FDA monitors foods and food ingredients for sale except for meat, poultry, and a few processed egg products. The regulatory agency imposes hefty penalties on businesses that fail to comply with the regulations. The FDA may also issue a stop sale or ban the sale of your product if any non-compliance is identified.
Every food manufacturer, packer, processor, distributor needs to submit certain records to the FDA to ensure all food products are safe and healthy for use.
Make foods with proper nutritional value. Give nutrient information in a standardized format followed by meeting label compliance.
There are specific regulatory requirements in place for food products, such as low-acid canned food, seafood, juice.
Registering with the FDA is mandatory in the USA even if you have not started manufacturing, packing, processing or stocking food for human or animal consumption.
The FDA monitors foods and food ingredients for sale and will impose penalties on any business that can’t comply with regulatory compliance. This can include banning your product from sale in stores and online if there are non-compliances. These regulations require that anyone in the food and beverage industry submit records to the FDA to make sure their products are safe & healthy for use, make foods with nutritional value displayed to meet label compliance and comply with facility registration. There are also specific requirements in place for different food products like low-acid canned food, juice, and seafood. These FDA regulations and guidelines are constantly changing and the paperwork can be quite complex, If you’d like us to help you, we’d be happy to.
There are no FDA fees for a food facility but foreign facilities will need to have an approved US FDA Agent in order to be compliant.
According to the Nutrition Labelling and Education Act of 1990, almost all foods require 5 basic level requirements: quantity of content, nutritional information, ingredients, manufacturer or distributor, and product name.
The food & beverage compliance solutions for the USA we offer consists of:
Learn about the FDA’s delay of MoCRA GMP to October 2025 and discover how cosmetic companies can prepare for compliance with MoCRA regulations.
... Read moreUnderstanding the FDA classification system for medical devices is key to getting your product to market safely and efficiently. Knowing how the FDA medical devices
... Read moreUnderstand the key differences between a VHP Canadian representative and a VHP Importer of Record to ensure regulatory compliance.
... Read moreLearn how to sell your NHP on Amazon Canada with this complete guide. From regulations to marketing, get expert tips to maximize sales.
... Read morePlease complete the form below. We will respond to you soon.
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.