Are you trying to make sense of the FDA’s 510(k) pre-submission process? You’re not alone. Many companies, especially those new...
Andrew Parshad
November 15, 2024
Are you ready to introduce your infant formula to the Canadian market? Health Canada’s stringent regulations ensure the safety, quality,...
Andrew Parshad
November 5, 2024
Health Canada Opens 75-Day Consultation on Batch 4b – Share Your Input The Natural and Non-Prescription Health Products Directorate (NNHPD)...
Andrew Parshad
November 1, 2024
Introduction Preparing for an FDA audit can be challenging, especially for dietary supplement manufacturers who must meet stringent Good Manufacturing...
Andrew Parshad
November 1, 2024
Navigating Health Canada’s drug submission pathways can be daunting. How do you know which pathway—ANDS, SNDS, or NDS—best suits your...
Andrew Parshad
November 1, 2024
Navigating Canada’s pharmaceutical regulations can be overwhelming for businesses, especially those dealing in food products, ingredients, and additives. Two pivotal...
Andrew Parshad
October 30, 2024
FDA User Fees for Fiscal Year 2025 (FY2025) The FDA’s user fees for FY2025, which runs from October 1, 2024,...
Andrew Parshad
October 29, 2024
Simplified Explanation of Changes to Labeling Rules Starting July 2022, food manufacturers and suppliers have been required to display special...
Andrew Parshad
October 28, 2024
GRAS Experts, a new division aimed at tackling ingredient safety concerns and helping businesses stay ahead of regulatory changes and...
Andrew Parshad
October 25, 2024
The Canadian Food Inspection Agency (CFIA) has launched a 90-day consultation on proposed guidance for labelling plant-based alternatives to egg...
Andrew Parshad
October 25, 2024
The NNHPD Opens Consultation on Batch 4 Through new guidelines, stakeholders are invited to shape the future of homeopathic and...
Andrew Parshad
October 23, 2024
Are your novel food products ready for the new European Food Safety Authority (EFSA) regulations? If you’re planning to enter...
Andrew Parshad
October 17, 2024
Health Canada has just released a draft Good Manufacturing Practices (GMP) guide for natural health products (NHPs), marking a monumental...
Andrew Parshad
October 16, 2024
Natural health products (NHPs) are widely used in Canada, ranging from vitamins, minerals, and herbal remedies to probiotics and homeopathic...
Andrew Parshad
October 6, 2024
Regulatory Considerations when Selling Foods and Beverages in the United States Selling food products in the United States requires...
Andrew Parshad
August 29, 2024
Health Canada 2024 Changes for Nicotine Replacement Therapies (NRT) On August 22, 2024, the Honourable Mark Holland, Minister of Health,...
Andrew Parshad
August 21, 2024
How to Create Health Canada Compliant Food Labels When entering the Canadian market, designing your food labels correctly is not...
Andrew Parshad
August 17, 2024
The FDA has taken a significant step forward in its ongoing sodium reduction initiative by issuing new, voluntary sodium reduction...
Andrew Parshad
August 17, 2024
This fall, Health Canada is anticipating sharing a policy consultation document about health products containing (CBD). This proposal has been...
Andrew Parshad
August 8, 2024
The Modernization of Cosmetics Regulation Act (MoCRA) brings significant changes for everyone in the cosmetics industry, from manufacturers to distributors....
Andrew Parshad
July 6, 2024
Health Canada has unveiled its Forward Regulatory Plan for 2024-2026, outlining significant amendments to the Natural Health Products Regulations and...
Andrew Parshad
July 6, 2024
Health Canada is introducing a new plan to modernize the Drug Establishment Licensing (DEL) framework over the coming years. This...
Andrew Parshad
July 3, 2024
We understand the impact of changing Amazon Canada regulations on your business – and how non-compliance can hurt you. Q:...
Quality Smart Solutions
May 3, 2024
FDA (U.S) has recently revised its regulatory framework for laboratory-developed tests (LDTs). These in vitro diagnostic products (IVDs) are critical...
Quality Smart Solutions
May 3, 2024
Remember the days of gumming patches, sucking lozenges, and hiding bulky vaporizers? Nicotine pouches, those discreet little packets promising rapid...
Andrew Parshad
January 7, 2024
Attention all yogurt makers, big and small! The U.S. Food and Drug Administration (FDA) has finalized changes to the standard...
Andrew Parshad
January 2, 2024
When it comes to introducing new substances into the world of food and dietary supplements, ensuring safety is paramount. The...
Andrew Parshad
November 6, 2023
Introduction The process of bringing a medical device to market in the United States involves stringent regulations imposed by the...
Andrew Parshad
November 2, 2023
https://youtu.be/dVbug89UHBA Introduction In food safety management, Hazard Analysis and Critical Control Points (HACCP) is a systematic approach that ensures the...
Andrew Parshad
November 2, 2023
Navigating the intricate landscape of food and food additive regulation in the United States involves understanding the GRAS concept – “Generally...
Andrew Parshad
October 31, 2023
Are you curious about GRAS substances? Look no further! This comprehensive guide takes you from A to Z, covering everything...
Andrew Parshad
October 26, 2023
Introducing the Supplemented Foods Facts Table (SFFT), your go-to guide for navigating the ever-changing world of supplemented foods. With consumer...
Andrew Parshad
October 25, 2023
https://youtu.be/E0E0dohMpC4 So, you’re a medical device manufacturer eyeing the Canadian market? Great choice! But before you dive in, let’s talk...
Andrew Parshad
October 18, 2023
https://youtu.be/QABD-2XIRz0 Canada is known for its diverse culinary landscape. If you’re considering selling food products in this country, you’re in...
Andrew Parshad
October 12, 2023
Navigating the intricate world of medical devices can be daunting, especially when it comes to ensuring their safety and effectiveness....
Andrew Parshad
October 11, 2023
The pharmaceutical industry ensures public health by developing, manufacturing, and distributing safe and effective medications. For any drug to be...
Andrew Parshad
October 4, 2023
Introduction In the ever-changing world of medical device manufacturing, ensuring your product complies with regulations is akin to navigating stormy...
Andrew Parshad
September 29, 2023
Introduction In the world of medical devices, ensuring patient safety and efficacy is paramount. The 510(k) submission process is a...
Andrew Parshad
September 28, 2023
Introduction: As a food manufacturer in Canada, ensuring that your product labels comply with Health Canada’s regulations is crucial for...
Andrew Parshad
September 27, 2023
As a business owner operating in dietary supplements and health products, you are undoubtedly aware of the ever-evolving regulatory...
Andrew Parshad
September 27, 2023
https://youtu.be/MlufAYFqQ1s In dietary supplements, navigating the intricate regulatory landscape is a challenging yet indispensable aspect of launching your product. Submitting...
Andrew Parshad
September 26, 2023
Health Canada Approves Alpha GPC in Foods On September 20, 2023, Health Canada approved the use of L-alpha-glycerylphosphorylcholine (alpha GPC)...
Andrew Parshad
September 21, 2023
https://youtu.be/uuXA8yHrrZc Introduction: In response to the FDA’s recent draft guidance on the Registration and Listing of Cosmetic Product Facilities and Products,...
Andrew Parshad
September 20, 2023
https://youtu.be/x4c0LEPmJuM If you’re selling food products in the United States, understanding and complying with FDA regulations is non-negotiable. The Food...
Andrew Parshad
September 19, 2023
Introduction: Health Canada’s Natural Products Number (NPN) application process is vital for manufacturers and distributors of natural health products (NHPs)...
Andrew Parshad
September 19, 2023
Introduction: Staying up-to-date with the latest regulations and tools is crucial in medical device submissions. As of June 9, 2023,...
Andrew Parshad
September 15, 2023
https://youtu.be/rxz4HJOd6-M You’re about to step into a regulated industry designed to ensure the safety and quality of products. To successfully...
Andrew Parshad
September 14, 2023
Introduction: For importers in the global food trade, ensuring the safety and compliance of imported products is a top priority....
Andrew Parshad
September 13, 2023
*This summary of Health Canada’s guidance document provides compliance details for manufacturers submitting a new or amended application. Under the...
Andrew Parshad
September 11, 2023
https://youtu.be/T3pLp1dF08Y The Food Safety Modernization Act (FSMA) Made Simple Imagine a world where preventing food-related illnesses is more important than...
Andrew Parshad
September 9, 2023
https://youtu.be/T3pLp1dF08Y Introduction: In the intricate world of global trade, ensuring the safety and compliance of imported and exported food products...
Andrew Parshad
September 7, 2023
From FDA guidelines to global regulatory standards, understanding the nuances of each requirement is essential to ensure a timely...
Andrew Parshad
September 6, 2023
In the realm of food production and processing, safety is paramount. Ensuring our food is free from contaminants and meets...
Andrew Parshad
September 5, 2023
Introduction: So you’ve got a game-changing medical device that could reshape healthcare as we know it. Amazing! But before...
Andrew Parshad
August 30, 2023
https://youtu.be/dVbug89UHBA In today’s fast-paced and diverse industries, pursuing safety and quality isn’t just a goal; it’s a non-negotiable commitment. This...
Andrew Parshad
August 28, 2023
Introduction In a groundbreaking move, the Association of American Feed Control Officials (AAFCO) has given the green light to an extensive overhaul...
Andrew Parshad
August 24, 2023
https://youtu.be/mWaBQzsa1_M Introduction: Navigating international trade regulations and the intricacies of Importer of Record (IOR) compliance and taxes can be complex....
Andrew Parshad
August 24, 2023
Understanding Food Labels: A Simple Guide Food labels are more than just ingredient stickers on packaging; they are a key...
Andrew Parshad
August 23, 2023
Del Health Canada is a crucial regulatory body responsible for ensuring the safety and effectiveness of drugs and medical devices...
Andrew Parshad
August 23, 2023
Health Canada, the Canadian federal health department, oversees the regulation of controlled substances in Canada. Controlled substances are regulated due...
Andrew Parshad
August 22, 2023
The Canadian Food Inspection Agency (CFIA) has regulated food products for many years, with a particular focus on the safety...
Andrew Parshad
August 18, 2023
Quality Management Systems (QMS) are an essential part of the life sciences healthcare industry, and many people need clarification on...
Andrew Parshad
August 18, 2023
Are you ready to take your business to new heights? Look no further. In this comprehensive guide, we will unlock...
Andrew Parshad
August 16, 2023
Health Canada publishes product monographs to describe a product’s health risks, benefits, and performance. Product monographs are for health products...
Andrew Parshad
August 15, 2023
Using a medical device import agent can offer several benefits, especially if you are navigating the complex process of...
Quality Smart Solutions
August 14, 2023
Quality Smart Solutions offers the best FDA Facility Renewal & Registration services in North America for Medical Devices, Food, and...
Quality Smart Solutions
August 13, 2023
Introduction: The European Food Safety Authority (EFSA) provides regulatory guidance and oversees the approval process for novel foods in the...
Quality Smart Solutions
August 11, 2023
Navigating the complex medical device regulatory process can often feel like decoding a cryptic language. Manufacturers grapple with an intricate...
Quality Smart Solutions
August 10, 2023
Food manufacturers everywhere are willing to jump through hurdles to receive their GRAS Notifications and access to the generally recognized...
Quality Smart Solutions
August 9, 2023
https://youtu.be/uuXA8yHrrZc Introduction: Behold the “Modernization of Cosmetic Regulation Act of 2022” that President Biden signed on December 29, 2022. This...
Quality Smart Solutions
August 9, 2023
This guidance provides suggestions and instructions to assist in submitting cosmetic product facility registrations and product listings to the FDA....
Quality Smart Solutions
August 8, 2023
Are you looking to bring your natural health product to market? Navigating the process of obtaining a license can be...
Quality Smart Solutions
August 2, 2023
In today’s rapidly evolving regulatory landscape, businesses face many challenges regarding ensuring compliance and product safety. One crucial aspect often...
Quality Smart Solutions
August 2, 2023
Are you a medical device manufacturer looking to enter the Canadian market? Navigating the regulatory landscape can be overwhelming,...
Quality Smart Solutions
August 1, 2023
Are you a health and wellness entrepreneur looking to bring your products to the Canadian market? Navigating the Health Canada...
Quality Smart Solutions
August 1, 2023
Are you ready to break new ground in healthcare and drug testing? Opening a drug testing facility can be challenging...
Quality Smart Solutions
July 28, 2023
Are you looking to tap into the immense potential of the Canadian market and boost your e-commerce success? Look only...
Quality Smart Solutions
July 28, 2023
In the dynamic and ever-evolving world of pharmaceuticals, ensuring compliance with FDA regulations is paramount. One crucial aspect that must...
Quality Smart Solutions
July 25, 2023
Are you a medical professional or someone involved in the healthcare industry? If so, you’ve likely come across the...
Quality Smart Solutions
July 20, 2023
In a world where culinary boundaries are constantly expanding, the future of food holds endless possibilities. Enter EFSA Novel Foods,...
Quality Smart Solutions
July 19, 2023
In today’s global economy, businesses increasingly use international trade to source materials and sell products. However, the complex regulations...
Quality Smart Solutions
July 18, 2023
Introduction: Quality assurance is an essential part of clinical trials. It involves a set of processes that ensure that the...
Quality Smart Solutions
July 18, 2023
Introduction: Health Canada’s new dietary supplement regulations, which are intended to revamp an already successful system, are unintentionally harming both...
Quality Smart Solutions
July 17, 2023
As a researcher, you know that the success of your study depends on many factors, from the quality of...
Quality Smart Solutions
July 14, 2023
As the saying goes, prevention is always better than a cure. This is particularly true regarding food safety in the...
Quality Smart Solutions
July 13, 2023
As a company developing new products, ensuring they are safe for consumption is essential. One way to achieve this is...
Quality Smart Solutions
July 12, 2023
Food safety is a top priority for Canadians. With so many potential hazards lurking in our food supply, it’s more...
Quality Smart Solutions
July 12, 2023
Consumers are becoming more discerning about their food in today’s increasingly health-conscious society. They want to know that their products...
Quality Smart Solutions
July 11, 2023
https://youtu.be/mWaBQzsa1_M Introduction In the world of international trade, importers of record play a crucial role in ensuring smooth customs clearance...
Quality Smart Solutions
July 11, 2023
https://youtu.be/cct8v4aXvhc In the fast-paced and ever-evolving world of pharmaceuticals, staying ahead of the competition is crucial. And one vital tool...
Quality Smart Solutions
July 8, 2023
https://youtu.be/dVbug89UHBA Welcome to a comprehensive Hazard Analysis and Critical Control Points HACCP process exploration. In today’s world, ensuring the safety...
Quality Smart Solutions
July 7, 2023
Non-Conformance Reports Introduction: In today’s fast-paced and competitive business landscape, identifying and resolving issues is crucial for maintaining the...
Quality Smart Solutions
July 7, 2023
Introduction to Cosmetic Regulations by the FDA: Are you a cosmetics brand looking to navigate the complex world of FDA...
Quality Smart Solutions
July 6, 2023
When thinking about NDI Classification have you ever heard about the New Dietary Ingredient Notification in Ingredient Compliance? In today’s...
Quality Smart Solutions
June 30, 2023
Are you a business owner in the health and wellness industry looking to navigate the complex regulatory landscape in Canada?...
Quality Smart Solutions
June 29, 2023
In marketing, the power of persuasive structure-function claims cannot be underestimated. Regarding consumer perception and product sales, structure-function claims have...
Quality Smart Solutions
June 29, 2023
In a world where the pharmaceutical industry is constantly evolving and new drugs are being introduced to the market every...
Quality Smart Solutions
June 28, 2023
Are you a food, beverage, drug, or cosmetics business owner?If so, you already know how crucial it is to comply...
Quality Smart Solutions
June 26, 2023
Introduction: Welcome to the ultimate guide to conducting a successful clinical trial, where we will delve into the best practices...
Quality Smart Solutions
June 23, 2023
The safety evaluation of direct food additives and color additives used in food will be evaluated in this blog post...
Quality Smart Solutions
June 21, 2023
In today’s competitive marketplace, selling products on Amazon has become a lucrative opportunity for many entrepreneurs and businesses. However, navigating...
Quality Smart Solutions
June 21, 2023
https://youtu.be/iVJlCZmDeWU In today’s highly competitive food industry, ensuring the safety and quality of products is of utmost importance. One key...
Quality Smart Solutions
June 20, 2023
In this blog, we discuss the benefits, challenges, steps, and opportunities a medical device establishment license can offer manufacturers and...
Quality Smart Solutions
June 19, 2023
Are you a company in the healthcare or pharmaceutical industry looking to bring a new product to market? If so,...
Quality Smart Solutions
June 16, 2023
In the ever-evolving healthcare landscape, staying up-to-date with the latest regulations and requirements is crucial for health professionals. And when...
Quality Smart Solutions
June 15, 2023
https://youtu.be/mWaBQzsa1_M Introduction Welcome to a fascinating journey through the world of imported foods in Canada, where flavors from all corners...
Quality Smart Solutions
June 14, 2023
Are you a business owner in the health and wellness industry? If so, you’re likely familiar with Health Canada’s Natural...
Quality Smart Solutions
June 14, 2023
Proper documentation is essential in any business operation and is particularly crucial when it comes to PMA submissions. Preparing and...
Quality Smart Solutions
June 13, 2023
The U.S. Food and Drug Administration (FDA) published two final guidelines on March 24, 2023, to help manufacturers of medical devices transition...
Quality Smart Solutions
June 13, 2023
The healthcare industry is constantly evolving, and with the introduction of new technologies, it is becoming more efficient and effective...
Quality Smart Solutions
June 8, 2023
Consumers rely on Health Canada monographs to ensure the safety and efficacy of their products. But have you ever wondered...
Quality Smart Solutions
June 7, 2023
Introduction: When it comes to the pharmaceutical industry, there is no room for error. The production of pharmaceuticals requires strict...
Quality Smart Solutions
June 6, 2023
https://youtu.be/mWaBQzsa1_M If you’re a business owner looking to expand your reach into the Canadian market, importing products may be a...
Quality Smart Solutions
June 6, 2023
As more and more people become health-conscious, the demand for supplements has skyrocketed. One of the most popular supplements on...
Quality Smart Solutions
June 2, 2023
Medical devices play a crucial role in modern healthcare, providing patients with life-changing treatments and improving the quality of...
Quality Smart Solutions
June 1, 2023
As a business owner in the medical industry, you understand the importance of providing quality products and services to your...
Quality Smart Solutions
May 31, 2023
https://youtu.be/mtmJgcfh9gI If you are planning to, import, distribute, or sell medical devices in Canada or manufacture Class I medical...
Quality Smart Solutions
May 29, 2023
Are you running a business that deals with food, drugs, medical devices, cosmetics, or dietary supplements? If so, you must...
Quality Smart Solutions
May 25, 2023
In today’s global food supply chain, ensuring the safety and quality of food products is critical to protecting public health...
Quality Smart Solutions
May 25, 2023
The healthcare industry is constantly evolving, and one of the most significant advances has been implementing drug identification numbers (DINs)....
Quality Smart Solutions
May 24, 2023
Importing goods from other countries can be a lucrative business and a complex and tedious process. As an importer, you...
Quality Smart Solutions
May 24, 2023
As a medical device manufacturer, getting your product to market can be a complex process with various regulatory requirements to...
Quality Smart Solutions
May 23, 2023
Introduction: By extending the interim policy on the importation and sale of infant formulas, human milk fortifiers, and dietary products...
Quality Smart Solutions
May 18, 2023
https://youtu.be/mWaBQzsa1_M If you’re a business owner looking to expand your reach into the Canadian market, importing products may be a...
Quality Smart Solutions
May 17, 2023
In the pharmaceutical industry, proper drug submission management is crucial to the success of any drug development process. The submission...
Quality Smart Solutions
May 16, 2023
Health Canada has the authority to set and charge health product fees under the Food and Drugs Act (FDA). On...
Quality Smart Solutions
May 16, 2023
https://youtu.be/dVbug89UHBA The food industry has undergone a significant transformation in terms of safety and quality control over the years. From...
Quality Smart Solutions
May 15, 2023
What improvements are being made to support NHP site licensing? Internal template updates support: consistency between reviews-Fall 2023 Increased efficiencies...
Quality Smart Solutions
May 12, 2023
Are you considering getting your food safety certification? In today’s highly competitive food industry, ensuring your food products are safe...
Quality Smart Solutions
May 11, 2023
https://youtu.be/dVbug89UHBA HACCP (Hazard Analysis and Critical Control Points) certification is a food safety management system that helps businesses identify and...
Quality Smart Solutions
May 5, 2023
As our world becomes increasingly globalized, the importation of food has become a common practice. However, with growing concerns...
Quality Smart Solutions
May 3, 2023
https://youtu.be/iVJlCZmDeWU Introduction: In the dynamic realm of food innovation, ushering in new ingredients responsibly and securely is of paramount importance....
Quality Smart Solutions
April 25, 2023
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,...
Quality Smart Solutions
April 25, 2023
Introduction: On April 13th, the Federal Trade Commission sent letters to warn hundreds of marketers to refrain from misleading customers with product...
Quality Smart Solutions
April 21, 2023
https://youtu.be/iVJlCZmDeWU Introduction: If you’re a food manufacturer, you need to understand the generally recognized as safe (GRAS) process. This process...
Quality Smart Solutions
April 18, 2023
https://youtu.be/NN8ZLynq6kE If you work in the food service industry, you may need to obtain food handlers license to ensure that...
Quality Smart Solutions
April 17, 2023
https://youtu.be/wOKeuDAEfss Have you ever wondered what it means for a food or ingredient to be ‘Generally Regarded as Safe’ (GRAS)?...
Quality Smart Solutions
April 13, 2023
https://youtu.be/dVbug89UHBA In the food industry, ensuring the safety of the products you produce is of utmost importance. One key aspect...
Quality Smart Solutions
April 13, 2023
As technology continues to advance, the use of Software as Medical Devices (SaMD) is becoming more prevalent in the...
Quality Smart Solutions
April 13, 2023
BRC certification is a globally recognized standard for food safety and quality management. In Canada, it is becoming increasingly important...
Quality Smart Solutions
April 12, 2023
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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April 11, 2023
https://youtu.be/wOKeuDAEfss Have you ever wondered what goes into the food you eat every day? Various food additives enhance our food’s...
Quality Smart Solutions
April 5, 2023
Introduction: In a recent update released on March 27, 2023, the FDA announced it has stopped accepting and processing VCRP submissions to...
Quality Smart Solutions
April 4, 2023
Navigating the complexities of the regulatory requirements for dietary supplements can be daunting. However, by understanding the framework, you can...
Quality Smart Solutions
April 4, 2023
https://youtu.be/iVJlCZmDeWU GRAS certification is an important step for any manufacturer who wants to market a food or food-related product. By...
Quality Smart Solutions
April 3, 2023
Introduction: FDA approvals can be a complex process, but understanding its important steps can give you insight into how drugs...
Quality Smart Solutions
March 27, 2023
Introduction: Manufacturing and selling medical devices in Canada can be a complex process and requires adherence to Health Canada’s...
Quality Smart Solutions
March 22, 2023
As a business owner, keeping up with regulatory requirements is a top priority. One such requirement is the FDA’s renewal...
Quality Smart Solutions
March 22, 2023
Quality Smart Solutions offers the best FDA Facility Renewal & Registration services in North America for Medical Devices, Food, and...
Quality Smart Solutions
March 21, 2023
The price for an MDEL (Medical Device Establishment Licence) and MDL (Medical Device Licence) in Canada varies according to the...
Quality Smart Solutions
March 20, 2023
The cost to register an FDA Medical Device Establishment is USD $6,493 for 2023. The FDA’s fiscal year 2023...
Quality Smart Solutions
March 16, 2023
Introduction to GRAS: Understanding the regulations and safety risks associated with GRAS ingredients can be tricky, but it doesn’t have...
Quality Smart Solutions
March 16, 2023
https://youtu.be/dVbug89UHBA Introduction: Food safety is an important part of any food business. It’s also a complicated one. There are many...
Quality Smart Solutions
March 15, 2023
The Licensing and Non-paired Health Products Directorate (LNHPD) is a federal government organization that oversees the regulation of natural...
Quality Smart Solutions
March 14, 2023
Looking for a quality import service can be a daunting task, but with the right advice and tips, you can...
Quality Smart Solutions
March 13, 2023
What are Class 1 Medical Devices? Class 1 medical devices are the lowest risk category of medical devices, as...
Quality Smart Solutions
March 8, 2023
PMRA Annual Fees reduced for Reporting and Applications: Health Canada is implementing a new approach beginning April 1, 2023....
Quality Smart Solutions
March 7, 2023
https://youtu.be/dVbug89UHBA The purpose of a Hazard Analysis Critical Control Points (HACCP) plan is to identify and control any hazards that...
Quality Smart Solutions
March 7, 2023
Background: Health Canada issued three interim orders to allow the importation and sale of medical devices used to diagnose,...
Quality Smart Solutions
March 7, 2023
Introduction: The sections relating to the disclosure of fragrance allergens because of the regulations go into effect two years following...
Quality Smart Solutions
March 3, 2023
Introduction: Are you looking to get GMP certification for your business? Getting certified is a process that involves understanding and...
Quality Smart Solutions
March 1, 2023
Introduction: Cosmetic labelling is an essential part of developing and marketing cosmetics. Companies must meet government requirements for labelling,...
Quality Smart Solutions
February 24, 2023
Introduction: The US Food and Drug Administration (FDA) issued draft guidance for comment today to help ensure appropriate labelling of...
Quality Smart Solutions
February 22, 2023
Introduction: Submitting a new drug to Health Canada can be a complex and time-consuming process. This post will provide...
Quality Smart Solutions
February 22, 2023
Introduction: A 510(k) clearance is a process by which medical device manufacturers notify the FDA of their intent to market...
Quality Smart Solutions
February 21, 2023
Introduction: Navigating the intricate web of medical device regulations can be daunting for businesses unfamiliar with the regulatory landscape....
Quality Smart Solutions
February 15, 2023
Introduction: If you are wondering what foods and substances the FDA considers to be Generally Recognized As Safe (GRAS), you have...
Quality Smart Solutions
February 12, 2023
Introduction: On August 1, 2022, the FDA announced the final guidance on FDA’s policy regarding products labeled as dietary supplements...
Quality Smart Solutions
February 8, 2023
Introduction: Class 3 medical devices are subject to the highest level of scrutiny and require special attention when it comes...
Quality Smart Solutions
February 7, 2023
Introduction: FSMA stands for the “Food Safety Modernization Act” which is a set of laws enacted by the US government...
Quality Smart Solutions
February 1, 2023
https://youtu.be/XRZ87ifRki0 Introduction: The Global Food Safety Initiative (GFSI) is an international organization that sets standards for food safety and quality...
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January 31, 2023
Introduction: The FDA may have turned a blind eye to companies like Bio Steel in the past who’ve been selling...
Quality Smart Solutions
January 27, 2023
Introduction: There are many reasons that you might want to get licensed as a food processor or retail operator. You...
Quality Smart Solutions
January 25, 2023
Submitting a 510K Premarket Notification is an essential step in the process of getting medical devices approved by the...
Quality Smart Solutions
January 23, 2023
https://youtu.be/dVbug89UHBA Are you looking to get certified in the Hazard Analysis and Critical Control Points (HACCP) system? The purpose of...
Quality Smart Solutions
January 21, 2023
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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January 18, 2023
Introduction: The FDA offers an online dietary supplement labeling guide that provides labeling requirements for supplement manufacturers. The guide covers...
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January 11, 2023
https://youtu.be/XRZ87ifRki0 The Global Food Safety Initiative: What You Need to Know: The Global Food Safety Initiative (GFSI), founded in 2000,...
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January 4, 2023
Introduction Prior notice is a requirement for all food manufactured, processed, packed, or held outside the United States that is...
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December 28, 2022
Introduction Food additives are chemicals added to food products to enhance flavor, texture, or color. Fortunately, there is a list...
Quality Smart Solutions
December 21, 2022
Introduction: Meeting FSMA compliance requirements is one of the most important things a manufacturer can do to protect their business....
Quality Smart Solutions
December 15, 2022
Introduction Health Canada oversees the importation and sale of Veterinary health products (VHPs) in Canada through the VHP Notification Program....
Quality Smart Solutions
December 14, 2022
Introduction: Medical devices are an important part of healthcare and play a critical role in the treatment of patients....
Quality Smart Solutions
December 8, 2022
Introduction to GRAS & NDI An ingredient can get into the diet by being a food, food additive, drug, dietary...
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December 6, 2022
https://youtu.be/dVbug89UHBA HACCP, which stands for Hazard Analysis and Critical Control Points, is the cornerstone of food safety plans in the...
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November 30, 2022
Introduction On November 21, 2022, the Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition issued warning...
Quality Smart Solutions
November 30, 2022
Food is one of the most important parts of our lives. We eat it to stay alive, and we eat...
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November 23, 2022
Introduction: FDA regulations for Class 1 medical devices can be daunting and confusing to navigate. However, with this easier-to-understand...
Quality Smart Solutions
November 16, 2022
Navigating the medical device regulations set by Health Canada can be a complicated task, but knowing the specific classification...
Quality Smart Solutions
November 16, 2022
The Medical Device License is a legal document required to manufacture, sell, and distribute medical devices. The Medical Device...
Quality Smart Solutions
November 15, 2022
The Canadian Food Inspection Agency (CFIA) protects Canadians’ health and safety by ensuring food that reaches customers is safe, nutritious, and...
Quality Smart Solutions
November 9, 2022
U.S.A RRA FDA Draft Guidance: In a recent U.S. Food and Drug Administration (FDA) draft guidance detailing its implementation...
Quality Smart Solutions
November 7, 2022
Top Canada Cosmetic Regulations Cosmetic Notification Form (CNF) Canada is one of the most popular tourist destinations in the...
Quality Smart Solutions
November 4, 2022
Health Canada Announcement: The Minister of Health has introduced new front-of-package nutrition labeling laws for prepackaged food products, and...
Quality Smart Solutions
November 3, 2022
Background on FDA NAC Warning Letters: Navigating the FDA’s NAC system can be overwhelming. Understanding FDA warning letters is key...
Kalpna Mistry
November 2, 2022
The FDA or U.S. Food and Drug Administration recently announced the Fiscal Year Medical Device User Fee (MDUFA) amendments. The...
Quality Smart Solutions
November 1, 2022
Say you have a new ingredient and are ready to enter the US food market. To ensure this ingredient is...
Quality Smart Solutions
October 28, 2022
The Canadian government has a set of regulations in place for natural health products (NHPs). These regulations help to...
Quality Smart Solutions
October 18, 2022
Foreign Supplier Verification Program (FSVP) Due to the increasingly global nature of today’s industry, an increasing number of businesses...
Quality Smart Solutions
October 11, 2022
The Medical Device License is a legal document that is required for the manufacture, sale, and distribution of medical...
Quality Smart Solutions
October 5, 2022
Many drug industries are working in every country. To sell any OTC drug in Canada is not possible without...
Quality Smart Solutions
September 29, 2022
The FSVP Plan is a requirement for many companies to be FSMA compliant. It is the responsibility of the company...
Quality Smart Solutions
September 22, 2022
Nowadays almost all the facets of healthcare are well-equipped with the modern and latest technology tools, including software systems....
Quality Smart Solutions
September 15, 2022
Industry people and experts considering working with a company not registered with Health Canada should be aware of the regulatory...
Quality Smart Solutions
September 9, 2022
https://youtu.be/XRZ87ifRki0 Since the publishing of the Safe Foods for Canadians Regulations in 2017, there is now a requirement for a...
Quality Smart Solutions
September 1, 2022
https://youtu.be/iojmXU4ZSx4 What is Natural Health Products Ingredients Database (NHPID)? The Natural Health Products Ingredients Database (NHPID) is an electronic tool...
Chanpreet Juneja
August 29, 2022
https://youtu.be/O7GbA-Awo0g 1. What is the NHP Licensing Process/what is needed for it? This process involves the submission of a product...
Quality Smart Solutions
August 25, 2022
In this blog, we’ll focus on answering your questions about the SFCR License and Preventive Control Plans, including why they...
Andrew Lau
August 17, 2022
Overview Manufacturers of prescription and non-prescription drugs are required to obtain a Drug Identification Number (DIN) before the drug product...
Jessica Koves
August 10, 2022
https://youtu.be/veCBMkYUWEU Market Analysis and Overview of CPG Market: Will CBD Products be considered an NHP? The consumer packaged goods (CPG)...
Shahin Khazai
August 5, 2022
Navigating the FDA and NAC regulations can be intimidating, but with the right information and guidance, you’ll be able to...
Kalpna Mistry
August 4, 2022
Have you been anticipating the Food and Drug Regulations (FDR) adding supplemented foods as an official category of food?...
Quality Smart Solutions
July 26, 2022
What are the latest Natural Health Product Amendments (NHPR) Health Canada will be amending the Natural Health Products Regulations (NHPR)...
Quality Smart Solutions
July 11, 2022
Health Canada recently announced that Front-of-package labelling changes for foods are set to come into effect on July 20, 2022,...
Quality Smart Solutions
July 5, 2022
Do you want to learn about the food regulations for food sales in North America? This could include food facility...
Quality Smart Solutions
June 27, 2022
Who needs a Foreign Site Reference Number (FSRN)? For Natural Health Products (NHPs) manufactured, packaged, and/or labeled by sites located...
Chanpreet Juneja
June 16, 2022
As a license holder for Natural Health Products (NHPs), it is your responsibility to be aware of and educated on...
Quality Smart Solutions
June 15, 2022
This blog unpacks the distinctions between NHPs, Health Canada & FDA-approved drugs, and cosmetic product regulations that define these products. ...
Andrew Lau
June 9, 2022
Background On April 22, 2022, Health Canada issued a notice to the industry on the interim implementation of electronic...
Kalpna Mistry
June 8, 2022
Ever wonder why Why Food Labels are Important? Food labels provide important information about the food we eat, such as...
Jessica Koves
June 7, 2022
What is a cosmetic? Under Section 2 of the Food and Drugs Act, a cosmetic is defined as “any substance...
Andrew Lau
May 25, 2022
Introduction: The market for animal and pet products is growing at a rapid pace. With that, there is also a...
Quality Smart Solutions
May 18, 2022
What is HACCP? A common question that comes up in regulated industries, such as food manufacturing and processing, is “What...
Kalpna Mistry
May 12, 2022
COVID had significantly impacted the processing of NHP product license applications with delays in the processing of all classes of...
Chanpreet Juneja
May 10, 2022
In response to the COVID-19 public health emergency, FDA issued a declaration regarding the appropriateness of utilizing emergency use authorizations...
Femi Morakinyo
April 29, 2022
1. What are over-the-counter drug products (OTC drugs)? Non-prescription drugs also called over-the-counter (OTC drugs), are health products that can...
Kalpna Mistry
April 25, 2022
Introduction Dietary supplements in the USA are very similar to natural health products (NHP regulations) in Canada and many products...
Quality Smart Solutions
April 18, 2022
Are you a cosmetics manufacturer or distributor looking to navigate the complex world of regulatory compliance? Look no further...
Andrew Lau
April 11, 2022
On January 19, 2022, Health Canada announced a marketing authorization (MA) to permit manufacturers to voluntarily increase the amount of...
Kalpna Mistry
March 22, 2022
On December 11, 2021, Health Canada issued a notice regarding the annual adjustment of fees for drugs and medical devices...
Jessica Koves
March 11, 2022
Top 5 Tips to Successfully Secure an NPN Number In order to sell a Natural Health Product (NHP) in Canada...
Esther Liu
March 10, 2022
Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (the third interim...
Dhreeti Kapoor
March 8, 2022
What is a cosmetic? Under Section 2 of the Food and Drugs Act, a cosmetic is defined as “any substance...
Andrew Lau
February 24, 2022
Natural Health Products have different characterization, identification, quantification, and purity standards that you should know about to ensure the quality...
Andrew Lau
February 14, 2022
Regulatory agencies across the globe, including the U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines...
Kalpna Mistry
February 9, 2022
Manufacturers and companies exporting medical devices from Canada may be asked by foreign customers or foreign governments to supply certification...
Femi Morakinyo
February 5, 2022
The U.S. Food and Drug Administration (FDA) has communicated via Letter of Enforcement Discretion that it will not oppose or...
Quality Smart Solutions
February 3, 2022
What is a claim? A claim is a representation for sale. It can be presented as “a word, a sentence,...
Andrew Lau
January 24, 2022
In general, all drug products (including over-the-counters and biologics) must be authorized for sale by Health Canada, before they can be...
Femi Morakinyo
January 19, 2022
All Natural Health Products (NHPs) sold in Canada are subject to the Natural Health Products Regulations (NHPR). Natural Health Products...
Esther Liu
January 12, 2022
Introduction: The Consolidated Appropriations Act, recently passed by the US Congress, incorporates revisions to US cosmetics laws. The Modernization of...
Quality Smart Solutions
January 11, 2022
Summary of Health Canada Licensing and Update Reports Product Licensing A combined 1390/5045 (28%) of NHP product license application submissions...
Quality Smart Solutions
January 7, 2022
On November 24, 2021, The Food and Drug Administration (FDA) sent correspondence to industry requesting information on the past use...
Kalpna Mistry
January 4, 2022
Medicinal Mushrooms in powder, capsule or liquid form can be licensed as Natural Health Product (NHP) in Canada. To sell...
Andrew Lau
December 24, 2021
What is a Cosmetic? Cosmetics are a part of just about everyone’s life. Every day, most of us use products...
Kalpna Mistry
December 17, 2021
The classification of Foods and Natural Health Products (NHPs) can be considered difficult, grey, and convoluted. Sometimes even comes down...
Quality Smart Solutions
December 14, 2021
On October 13, 2021, the U.S. Food and Drug Administration (FDA) issued final guidance for the food industry that provides...
Kalpna Mistry
December 4, 2021
In the wake of the COVID-19 pandemic, preventive measures and a healthy lifestyle with an efficient immune system were suggested...
Femi Morakinyo
December 1, 2021
The US Environmental Protection Agency (EPA) is saddled with the responsibility to register pesticides in the US. This process is...
Femi Morakinyo
November 29, 2021
What to Expect After Submitting an NPN Application In order to sell a Natural Health Product (NHP) in Canada, you...
Esther Liu
November 19, 2021
Pet Foods and Human Food Labels are designed to look similar yet distinct. There are some similar label requirements and...
Quality Smart Solutions
November 8, 2021
The advancement of technology is rapidly progressing, and the evolution can be observed all around us. As cutting-edge technology becomes...
Jessica Koves
October 28, 2021
How to Minimize the Risk of Border Detention Shipping Consumer Packaged Goods As an importer of consumer packaged goods, unanticipated...
Benil Sable
October 25, 2021
Inspection of your food facility will help identify and fix any quality or processing deviations found regarding food safety. Review...
Quality Smart Solutions
October 20, 2021
What is Hemp Seed Oil categorized as in Canada? In Canada, Hemp (Canna Sativa) seed oil can be categorized as...
Andrew Lau
October 13, 2021
It’s that time of year again! Any domestic and foreign establishments registered with US FDA must renew their registration annually...
Kalpna Mistry
October 11, 2021
The “Sunshine” vitamin, Vitamin D, Vitamin D3 or Vitamin D2 as it is more commonly known. The term “sunshine” was...
Quality Smart Solutions
October 4, 2021
What is a Cosmetic? Under Section 2 of the Food and Drugs Act, a cosmetic is defined as “any substance...
Andrew Lau
September 27, 2021
Advertising is something almost all people experience and view daily. Yet, it can be challenging to navigate this space as...
Quality Smart Solutions
September 21, 2021
On June 28, 2021, Health Canada opened a public consultation on a Unique Device Identification (UDI) system for medical devices...
Kalpna Mistry
September 14, 2021
Health Canada and the CFIA (Canadian Food Inspection Agency) are teaming up to plan advancements and improvements for the timing...
Quality Smart Solutions
September 8, 2021
In March 2020, Health Canada introduced interim measures to expedite the issuance of site licences for alcohol-based hand sanitizers, to...
Jessica Koves
September 1, 2021
Who Needs an MDSAP Certificate? Anyone looking to manufacture a Class II, III or IV medical device in Canada requires...
Andrew Parshad
August 20, 2021
On June 26, 2021, Health Canada launched a consultation on a proposal to improve natural health product labelling. Health Canada...
Jessica Koves
August 16, 2021
On June 25, 2021, Health Canada published a news release that announced proposed changes to the Natural Health Products Regulations....
Jessica Koves
August 13, 2021
In the world of compliance and quality management, audits are a fact of life. Auditing verifies adherence to standards or...
Benil Sable
August 11, 2021
On June 12, 2021, the Canadian Food Inspection Agency (CFIA) opened a consultation as part of the process to modernize...
Kalpna Mistry
August 6, 2021
Animal Supplements in the USA – What You Need to Know How are animal supplements regulated in the USA? Dietary...
Andrew Lau
August 2, 2021
The product label is something we all look at in our daily lives, but not everyone is well equipped with...
Quality Smart Solutions
July 27, 2021
Health Canada has been working on creating/revising the regulations with regards to Supplemented Foods for some time now. A recent...
Quality Smart Solutions
July 24, 2021
Health Canada has published a consultation paper on proposed changes to the regulation and oversight of clinical trials for drug,...
Andrew Parshad
July 16, 2021
How to Sell Dietary Supplements or NHPs on Amazon or Other Online Platforms in Canada? What is an NHP? In...
Andrew Lau
July 13, 2021
COVID-19 and Hard Surface Disinfectants – What You Need to Know In Canada, chemical products that are used to clean,...
Kalpna Mistry
July 6, 2021
Cancellation of Medical Device Establishment Licence for A Non-compliance With Annual Licence Review Requirements On May 27, 2021 Health Canada...
Andrew Parshad
July 2, 2021
CFIA and Health Canada have been working on new Food Safety guidance documents pertaining to Novel foods focused on plant...
Quality Smart Solutions
June 23, 2021
As of March 1, 2021, Interim Order No. 2 replaces Interim Order No. 1 Respecting the importation and sale of...
Andrew Parshad
June 15, 2021
Sesame will become the 9th major food allergen officially recognized by the United States (FDA) on January 1st, 2023. The...
Quality Smart Solutions
June 9, 2021
Natural Health Products (NHPs) are regulated by Health Canada under the authority of the Food and Drugs Act and the Natural...
Andrew Parshad
June 3, 2021
The coronavirus-19 (COVID-19) pandemic has had a long-lasting effect on many of the processes done in business and everyday life....
Quality Smart Solutions
May 12, 2021
After consultation with stakeholders and based on a noticeable lack of current regulations and need for availability and innovation for...
Quality Smart Solutions
May 7, 2021
Conventional Foods vs. Supplemented Foods The easiest way to know the difference between these categories are that Conventional foods are...
Quality Smart Solutions
April 20, 2021
Health Canada and the Canadian Food Inspection Agency have joined forces to evaluate the incorporation of Veterinary Health Products (VHPs)...
Quality Smart Solutions
March 15, 2021
Introduction: Identifying the correct application type has become increasingly crucial for Natural Health Product (NHP) applications. Incorrect classification can result...
Quality Smart Solutions
March 1, 2021
In order for food that is regulated under the Safe Food for Canadians Regulations, to be imported into Canada, the...
Andrew Parshad
February 15, 2021
Health Canada recently published an additional notice regarding all interim orders relating to COVID-19 and Medical Devices. This notice is...
Kalpna Mistry
December 15, 2020
On October 5, 2020, the Natural and Non-Prescription Health Products Directorate (NNHPD) sent a notice to all Canadian product licence...
Kalpna Mistry
October 9, 2020
On Monday September 21st, the U.S. Food and Drug Administration (FDA) announced a proposed rule to establish additional traceability record...
Quality Smart Solutions
September 25, 2020
Earlier this summer, Health Canada provided a notice to industry on the regulatory considerations for non-medical masks or face coverings,...
Kalpna Mistry
September 13, 2020
On May 23, 2020, the Minister of Health of Canada approved an Interim Order (IO) Respecting Clinical Trials for Medical...
Quality Smart Solutions
June 6, 2020
What is a HACCP Plan? Food safety is always evolving and becoming more complex, as companies require constant updating with...
Quality Smart Solutions
April 26, 2020
Recently in Canada, the Minister of Health has signed an Interim Order to allow expedited access to COVID-19-related medical devices...
Quality Smart Solutions
April 15, 2020
With the need for hand sanitizers significantly increasing for healthcare personnel and individuals during the current COVID-19 pandemic do help...
Andrew Parshad
March 22, 2020
The Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) introduces amendments to the Food and Drugs Act that will improve Health Canada’s ability to...
Quality Smart Solutions
February 3, 2020
All marketed drugs and health products have benefits and risks. All health products are carefully evaluated before they are licensed...
Quality Smart Solutions
January 31, 2020
All drugs subject to the Food and Drug Regulations are required to gain premarket authorization prior to issuance of a...
Quality Smart Solutions
January 29, 2020
When Health Canada authorizes a drug to be marketed in Canada, a Drug Identification Number (DIN) is issued to the...
Quality Smart Solutions
January 27, 2020
The label and package are the first points of interaction between a health product and a consumer. Prior to the...
Quality Smart Solutions
January 24, 2020
In continuation to the last article on Canadian legislations and requirements regarding the marketing of drugs and medical devices, this...
Quality Smart Solutions
January 22, 2020
Health Canada is not only the national regulatory authority for issuing health product marketing authorizations, but it also oversees and...
Quality Smart Solutions
January 20, 2020
Under the Food Safety Modernization Act (FSMA), the United States (U.S.) started graduated enforcement of the Foreign Supplier Verification Program...
Andrew Parshad
October 12, 2018
Natural Health Product Brand Name Guidance Brand names are an important part of your marketing strategy, but as many of...
Andrew Parshad
October 10, 2018
In September Amazon.ca notified every Natural Health Product vendor (whether they had an NPN or not) that, effective in October...
Andrew Parshad
October 7, 2018
The Safe Food for Canadians Act (SFCA) and the Safe Food for Canadians Regulations (SFCR) are set to come into...
Quality Smart Solutions
September 2, 2018
When it comes to topical essential oils, determining the correct regulatory pathway to ensure full compliance typically depends on how...
Quality Smart Solutions
August 28, 2018
The European Food Safety Authority (EFSA) is a world renowned regulator which is known for its high scientific standards when...
Quality Smart Solutions
August 11, 2018
Supplemented foods and natural health products (NHPs) can sometimes pose challenges when trying to determine the correct regulatory pathway to...
Quality Smart Solutions
July 26, 2018
https://youtu.be/BEsWTYXGqAQ Summertime has finally arrived and with it comes hot temperatures and intense ultraviolet rays. Exposure to ultraviolet light is...
Quality Smart Solutions
July 11, 2018
The Safe Food for Canadians Act (SFCA) and the Safe Food for Canadians Regulations (SFCR) are set to come into...
Quality Smart Solutions
July 5, 2018
Health Canada implemented the Plain Language Labelling (PLL) initiative to help make the labels for non-prescription health products easier to...
Quality Smart Solutions
June 2, 2018
In October 2014, the Natural and Non-prescription Health Products released a policy to manage the overall application review process. It...
Quality Smart Solutions
April 30, 2018
Just a little background information first before I talk about the business aspect of capitalizing on your NPN. NPN stands...
Andrew Parshad
February 19, 2018
On November 21, 2017 the Canadian Minister of Health announced the Proposed Approach to the Regulation of Canna. The public...
Andrew Parshad
November 22, 2017
On November 14, 2017 the Natural and Non-prescription Health Products Directorate (NNHPD) announced that there are several updates to the...
Andrew Parshad
November 15, 2017
This past June 2017 the Food and Drug Administration (FDA) put a hold on the compliance dates for Nutrition Facts...
Andrew Parshad
September 29, 2017
As discussed in an earlier post (PLL – Plain Language Labeling: What it means and how it affects you), the...
Andrew Parshad
September 19, 2017
Our sister company, Quality IMPORT Solutions has a new website with all the information you need to make an informed...
Andrew Parshad
August 6, 2017
BACKGROUND Originally implemented in 1920 after the inception of the Federal department of Health in 1919, the Food and Drugs...
Andrew Parshad
August 6, 2017
Some companies make the assumption that selling a dietary supplement product in Canada is no different than selling in the...
Andrew Parshad
February 9, 2015
Health Canada recently announced their initiative to modernize the regulatory framework for health products and foods. This is required due...
Andrew Parshad
March 1, 2014
Significant changes are occurring in the global regulatory landscape as of late, and this is just another example of how...
Andrew Parshad
March 1, 2014
We hope you found it as successful as we did. Feel free to email us at info@qualitysmartsolutions.com or give us...
Andrew Parshad
March 1, 2014
Who needs a Foreign Site Reference Number (FSRN)? For Natural Health Products (NHPs) manufactured, packaged, and/or labeled by sites located
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