Stay compliant with FDA drug establishment and listing renewal requirements before December 31, 2025. Learn key steps and how to file correctly.
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Learn how to get GRAS status for an enzyme and meet FDA safety requirements through proper evaluation, expert review, and documentation.
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FDA confirms NMN is lawful in dietary supplements after industry pressure. Learn what this means for your business and compliance strategy.
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Learn how to prepare Instructions for Use for FDA submission for medical devices. Stay compliant with FDA requirements and international standards.
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FDA proposes ending the self-affirmed GRAS pathway. Learn what this means for your business and how to stay compliant.
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Learn what GMP training is, why it matters, and who needs it. Explore GMP fundamentals and compliance requirements for Health Canada and FDA.
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Learn how a new bill may eliminate self-affirmed GRAS and what it means for food ingredient compliance. Stay ahead with expert support.
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Learn how the SAFE Sunscreen Standards Act could impact sunscreen compliance and FDA approvals.
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The FDA Food labeling compliance program has just been updated to help food manufacturers and importers meet U.S. labeling requirements more effectively. On June 20, 2025, the U.S. Food and Drug Administration (FDA) announced a revised Compliance Program Manual (CPM) for general food labeling.
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When preparing to launch a medical device in the U.S., one of the first and most important decisions
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Learn how to meet FDA’s new dietary ingredient notification requirements for dietary supplements with new educational tools.
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Compare pet supplements vs veterinary health products to stay compliant in the U.S. and Canada. Know the rules and get expert help to launch successfully.
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FDA’s FY 2025 OMUFA fees are due June 22 for OTC drug manufacturers and contract facilities. Learn what this means and how to stay compliant.
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Understand the GRAS process for human food vs. animal feed and how to stay compliant with FDA regulations.
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Learn the key differences between traditional cosmetics and cosmeceuticals to ensure regulatory compliance in Canada and the U.S.
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Learn what to do if you’re struggling with the GRAS compliance process. Follow these tips to avoid delays and meet FDA standards.
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FDA approves three food colors from natural sources, offering safer alternatives to petroleum-based dyes. Learn how this impacts your food products.
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FDA expands unannounced inspections for foreign sites. Learn what this means and how to stay compliant.
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The FDA has extended the comment period for the front-of-package labeling rule. Learn how this affects your business and how to submit feedback.
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Understand how to stay compliant with FDA and Health Canada rules for eczema products. Learn how to properly classify and register your product.
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Learn the key differences between FDA and Health Canada cosmetic compliance to meet regulatory requirements and avoid costly setbacks.
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FDA ESG NextGen is now officially live. If your company needs to submit regulatory documents to the FDA, you’ll now use this updated system instead of the retired WebTrader platform.
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Understand food and supplement labeling differences between Canada and the US to stay compliant and avoid costly delays.
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Avoid FDA medical device submission errors and improve your approval chances with these expert tips.
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Learn why some FDA Food Contact Notifications are no longer effective and how to ensure compliance with updated regulations.
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Attention all yogurt makers, big and small! The U.S. Food and Drug Administration (FDA) has finalized changes to the standard
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Learn the key differences between GRAS Notice and Self-Affirmed GRAS to ensure FDA compliance and food safety. Find the best approach for your product.
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Introduction In the world of medical devices, ensuring patient safety and efficacy is paramount. The 510(k) submission process is a
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As a business owner operating in dietary supplements and health products, you are undoubtedly aware of the ever-evolving regulatory
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https://youtu.be/MlufAYFqQ1s In dietary supplements, navigating the intricate regulatory landscape is a challenging yet indispensable aspect of launching your product. Submitting
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Learn how to legally sell dietary supplements in the U.S. by following FDA regulations, labeling requirements, and ingredient safety standards. Stay compliant and grow your business.
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Quality Smart Solutions offers the best FDA Facility Renewal & Registration services in North America for Medical Devices, Food, and
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Food manufacturers everywhere are willing to jump through hurdles to receive their GRAS Notifications and access to the generally recognized
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Are you ready to break new ground in healthcare and drug testing? Opening a drug testing facility can be challenging
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Are you a medical professional or someone involved in the healthcare industry? If so, you’ve likely come across the
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In today’s global economy, businesses increasingly use international trade to source materials and sell products. However, the complex regulations
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As a researcher, you know that the success of your study depends on many factors, from the quality of your
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Introduction to Cosmetic Regulations by the FDA: Are you a cosmetics brand looking to navigate the complex world of FDA
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When thinking about NDI Classification have you ever heard about the New Dietary Ingredient Notification in Ingredient Compliance? In today’s
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This article will delve deeper into structure-function claims, exploring their effectiveness, impact on consumer behavior, and leverage.
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In a world where the pharmaceutical industry is constantly evolving and new drugs are being introduced to the market every
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Introduction: Welcome to the ultimate guide to conducting a successful clinical trial, where we will delve into the best practices
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The safety evaluation of direct food additives and color additives used in food will be evaluated in this blog post
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In today’s competitive marketplace, selling products on Amazon has become a lucrative opportunity for many entrepreneurs and businesses. However, navigating
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Are you a company in the healthcare or pharmaceutical industry looking to bring a new product to market? If so,
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Proper documentation is essential in any business operation and is particularly crucial when it comes to PMA submissions. Preparing and
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The U.S. Food and Drug Administration (FDA) published two final guidelines on March 24, 2023, to help manufacturers of medical devices transition
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Introduction: When it comes to the pharmaceutical industry, there is no room for error. The production of pharmaceuticals requires strict
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As more and more people become health-conscious, the demand for supplements has skyrocketed. One of the most popular supplements on
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Are you running a business that deals with food, drugs, medical devices, cosmetics, or dietary supplements? If so, you must
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In today’s global food supply chain, ensuring the safety and quality of food products is critical to protecting public health
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Are you considering getting your food safety certification? In today’s highly competitive food industry, ensuring your food products are safe
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As our world becomes increasingly globalized, the importation of food has become a common practice. However, with growing concerns
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Introduction: In the dynamic realm of food innovation, ushering in new ingredients responsibly and securely is of paramount importance. This
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https://youtu.be/yvnTszySkgg If you’re in the medical device manufacturing business, you’re likely familiar with the FDA’s regulations, including FDA Furls. However,
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Introduction: On April 13th, the Federal Trade Commission sent letters to warn hundreds of marketers to refrain from misleading customers with product
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https://youtu.be/NN8ZLynq6kE If you work in the food service industry, you may need to obtain food handlers license to ensure that
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https://youtu.be/wOKeuDAEfss Have you ever wondered what it means for a food or ingredient to be ‘Generally Regarded as Safe’ (GRAS)?
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As technology continues to advance, the use of Software as Medical Devices (SaMD) is becoming more prevalent in the
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BRC certification is a globally recognized standard for food safety and quality management. In Canada, it is becoming increasingly important
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https://youtu.be/mWaBQzsa1_M Introduction Importing goods can be a complex process, especially when it comes to navigating customs regulations and compliance requirements.
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Introduction: FDA approvals can be a complex process, but understanding its important steps can give you insight into how drugs
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As a business owner, keeping up with regulatory requirements is a top priority. One such requirement is the FDA’s renewal
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Get the inside regulatory scoop on FDA food facility registration including submitting information, handling food products, and more.
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Introduction to GRAS: Understanding the regulations and safety risks associated with GRAS ingredients can be tricky, but it doesn’t have
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Introduction: A 510(k) clearance is a process by which medical device manufacturers notify the FDA of their intent to market
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We explore the FDA safety guidelines for NAC Supplements including marketing/labeling and utilizing FDA resources for guidance.
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Introduction: The FDA may have turned a blind eye to companies like Bio Steel in the past who’ve been selling
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Learn how to navigate the FDA GRAS database to ensure food ingredients are safe and compliant.
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Introduction: The FDA offers an online dietary supplement labeling guide that provides labeling requirements for supplement manufacturers. The guide covers
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Introduction Prior notice is a requirement for all food manufactured, processed, packed, or held outside the United States that is
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Introduction Food additives are chemicals added to food products to enhance flavor, texture, or color. Fortunately, there is a list
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Learn the key differences between GRAS vs NDI and how to choose the right FDA pathway for your ingredient. Stay compliant with expert insights.
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Introduction On November 21, 2022, the Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition issued warning
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The Medical Device License is a legal document required to manufacture, sell, and distribute medical devices. The Medical Device Licence
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Background on FDA NAC Warning Letters: Navigating the FDA’s NAC system can be overwhelming. Understanding FDA warning letters is key
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The FDA or U.S. Food and Drug Administration recently announced the Fiscal Year Medical Device User Fee (MDUFA) amendments. The
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Say you have a new ingredient and are ready to enter the US food market. To ensure this ingredient is
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Overview Manufacturers of prescription and non-prescription drugs are required to obtain a Drug Identification Number (DIN) before the drug product
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What is a cosmetic? Under Section 2 of the Food and Drugs Act, a cosmetic is defined as “any substance
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In response to the COVID-19 public health emergency, FDA issued a declaration regarding the appropriateness of utilizing emergency use authorizations
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Regulatory agencies across the globe, including the U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines
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The U.S. Food and Drug Administration (FDA) has communicated via Letter of Enforcement Discretion that it will not oppose or
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Introduction: The Consolidated Appropriations Act, recently passed by the US Congress, incorporates revisions to US cosmetics laws. The Modernization of
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On November 24, 2021, The Food and Drug Administration (FDA) sent correspondence to industry requesting information on the past use
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On October 13, 2021, the U.S. Food and Drug Administration (FDA) issued final guidance for the food industry that provides
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It’s that time of year again! Any domestic and foreign establishments registered with US FDA must renew their registration annually
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Sesame will become the 9th major food allergen officially recognized by the United States (FDA) on January 1st, 2023. The
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Learn the key differences between conventional and supplemented foods under Health Canada and FDA rules and how to stay compliant.
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On Monday September 21st, the U.S. Food and Drug Administration (FDA) announced a proposed rule to establish additional traceability record
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This past June 2017 the Food and Drug Administration (FDA) put a hold on the compliance dates for Nutrition Facts
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