Introduction In the world of medical devices, ensuring patient safety and efficacy is paramount. The 510(k) submission process is
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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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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 terms
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In today’s global economy, businesses increasingly use international trade to source materials and sell products. However, the complex regulations and
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As a researcher, you know that the success of your study depends on many factors, from the quality of
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Introduction to Cosmetic Regulations by the FDA: Are you a cosmetics brand looking to navigate the complex world of
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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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In marketing, the power of persuasive structure-function claims cannot be underestimated. Regarding consumer perception and product sales, structure-function claims have
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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: How Quality Smart Solutions can help At Quality Smart Solutions, we have a team of experts who are skilled in
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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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https://youtu.be/iVJlCZmDeWU In today’s highly competitive food industry, ensuring the safety and quality of products is of utmost importance. One key
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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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https://youtu.be/iVJlCZmDeWU Introduction: In the dynamic realm of food innovation, ushering in new ingredients responsibly and securely is of paramount importance.
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If you’re in the medical device manufacturing business, you’re likely familiar with the FDA’s regulations, including FDA Furls. However, understanding
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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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If you work in the food service industry, you may need to obtain food handlers license to ensure that you
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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 healthcare
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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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Quality Smart Solutions offers the best FDA Facility Renewal & Registration services in North America for Medical Devices, Food, and
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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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Introduction: On August 1, 2022, the FDA announced the final guidance on FDA’s policy regarding products labeled as dietary supplements
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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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Introduction Like most food businesses, you probably spend a lot of time thinking about what’s in your food and how
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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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Introduction to GRAS & NDI An ingredient can get into the diet by being a food, food additive, drug, dietary
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The Medical Device License is a legal document required to manufacture, sell, and distribute medical devices. The Medical Device
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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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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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