Good Manufacturing Practices GMP for pharmaceutical companies
Introduction: When it comes to the pharmaceutical industry, there is no room for error. The production of pharmaceuticals requires strict
... Read moreIntroduction: When it comes to the pharmaceutical industry, there is no room for error. The production of pharmaceuticals requires strict
... Read moreAs more and more people become health-conscious, the demand for supplements has skyrocketed. One of the most popular supplements on
... Read moreAre you running a business that deals with food, drugs, medical devices, cosmetics, or dietary supplements? If so, you must
... Read moreIn today’s global food supply chain, ensuring the safety and quality of food products is critical to protecting public
... Read moreAre you considering getting your food safety certification? In today’s highly competitive food industry, ensuring your food products are safe
... Read moreFSVP importers must maintain records of their verification activities, including hazard analysis documentation, supplier evaluations, and verification procedures. These records
... Read morehttps://youtu.be/iVJlCZmDeWU Introduction: If you’re a food manufacturer or producer, you may need to submit a GRAS notification to the FDA
... Read morehttps://youtu.be/yvnTszySkgg If you’re in the medical device manufacturing business, you’re likely familiar with the FDA’s regulations, including FDA Furls.
... Read moreIntroduction: On April 13th, the Federal Trade Commission sent letters to warn hundreds of marketers to refrain from misleading customers with product
... Read moreIf you work in the food service industry, you may need to obtain food handlers license to ensure that you
... Read morehttps://youtu.be/wOKeuDAEfss Have you ever wondered what it means for a food or ingredient to be ‘Generally Regarded as Safe’ (GRAS)?
... Read moreAs technology continues to advance, the use of Software as Medical Devices (SaMD) is becoming more prevalent in the
... Read moreBRC certification is a globally recognized standard for food safety and quality management. In Canada, it is becoming increasingly important
... Read moreIntroduction Importing goods can be a complex process, especially when it comes to navigating customs regulations and compliance requirements. That’s
... Read moreIntroduction: FDA approvals can be a complex process, but understanding its important steps can give you insight into how drugs
... Read moreAs a business owner, keeping up with regulatory requirements is a top priority. One such requirement is the FDA’s renewal
... Read moreQuality Smart Solutions offers the best FDA Facility Renewal & Registration services in North America for Medical Devices, Food, and
... Read moreIntroduction to GRAS: Understanding the regulations and safety risks associated with GRAS ingredients can be tricky, but it doesn’t have
... Read moreIntroduction: A 510(k) clearance is a process by which medical device manufacturers notify the FDA of their intent to
... Read moreIntroduction: On August 1, 2022, the FDA announced the final guidance on FDA’s policy regarding products labeled as dietary supplements
... Read moreIntroduction: The FDA may have turned a blind eye to companies like Bio Steel in the past who’ve been selling
... Read moreIntroduction Like most food businesses, you probably spend a lot of time thinking about what’s in your food and how
... Read moreIntroduction: The FDA offers an online dietary supplement labeling guide that provides labeling requirements for supplement manufacturers. The guide covers
... Read moreIntroduction Prior notice is a requirement for all food manufactured, processed, packed, or held outside the United States that is
... Read moreIntroduction Food additives are chemicals added to food products to enhance flavor, texture, or color. Fortunately, there is a list
... Read moreIntroduction to GRAS & NDI An ingredient can get into the diet by being a food, food additive, drug, dietary
... Read moreThe Medical Device License is a legal document required to manufacture, sell, and distribute medical devices. The Medical Device
... Read moreBackground on FDA NAC Warning Letters: Navigating the FDA’s NAC system can be overwhelming. Understanding FDA warning letters is key
... Read moreThe FDA or U.S. Food and Drug Administration recently announced the Fiscal Year Medical Device User Fee (MDUFA) amendments. The
... Read moreSay you have a new ingredient and are ready to enter the US food market. To ensure this ingredient is
... Read moreQuality Smart Solutions offers the best FDA Facility Renewal & Registration services in North America for Medical Devices, Food, and
... Read moreOverview Manufacturers of prescription and non-prescription drugs are required to obtain a Drug Identification Number (DIN) before the drug product
... Read moreWhat is a cosmetic? Under Section 2 of the Food and Drugs Act, a cosmetic is defined as “any substance
... Read moreIn response to the COVID-19 public health emergency, FDA issued a declaration regarding the appropriateness of utilizing emergency use authorizations
... Read moreRegulatory agencies across the globe, including the U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines
... Read moreThe U.S. Food and Drug Administration (FDA) has communicated via Letter of Enforcement Discretion that it will not oppose or
... Read moreIntroduction: The Consolidated Appropriations Act, recently passed by the US Congress, incorporates revisions to US cosmetics laws. The Modernization of
... Read moreOn November 24, 2021, The Food and Drug Administration (FDA) sent correspondence to industry requesting information on the past use
... Read moreOn October 13, 2021, the U.S. Food and Drug Administration (FDA) issued final guidance for the food industry that provides
... Read moreIt’s that time of year again! Any domestic and foreign establishments registered with US FDA must renew their registration annually
... Read moreSesame will become the 9th major food allergen officially recognized by the United States (FDA) on January 1st, 2023. The
... Read moreOn Monday September 21st, the U.S. Food and Drug Administration (FDA) announced a proposed rule to establish additional traceability record
... Read moreQuality 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.