Key Strategies to Improve Drug Submission Success
In the pharmaceutical industry, proper drug submission management is crucial to the success of any drug development process. The submission
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May 16, 2023
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[blog_list]
Emergency Alert: NNHPD proposed fees may lead to business closures
Health Canada has the authority to set and charge health product fees under the Food and Drugs Act (FDA). On
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May 16, 2023
From HACCP to CCPs: How Food Safety Standards Have Changed
The food industry has undergone a significant transformation in terms of safety and quality control over the years. From the
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May 15, 2023
The Importance of Food Safety Plans for Food Businesses
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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May 11, 2023
The cost of HACCP Certification: Everything to know about the Investment
https://youtu.be/dVbug89UHBA HACCP (Hazard Analysis and Critical Control Points) certification is a food safety management system that helps businesses identify and
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May 5, 2023
Why an FSVP Importer Is Essential for Food Safety
As our world becomes increasingly globalized, the importation of food has become a common practice. However, with growing concerns
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May 3, 2023
How GRAS Notification Supports FDA Food Ingredient Approval
Introduction: In the dynamic realm of food innovation, ushering in new ingredients responsibly and securely is of paramount importance. This
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April 25, 2023
Understanding FDA Furls and Their Impact on Medical Device Companies
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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April 25, 2023
Navigating the GRAS process: A guide for food manufacturers
https://youtu.be/iVJlCZmDeWU Introduction: If you’re a food manufacturer, you need to understand the generally recognized as safe (GRAS) process. This process
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April 18, 2023
How to get your Food Handlers License: Ultimate 5 step guide
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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April 17, 2023
Everything you should know about FDA GRAS Status in 2023
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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April 13, 2023
The role of Critical Control Points in your HACCP Plan
https://youtu.be/dVbug89UHBA In the food industry, ensuring the safety of the products you produce is of utmost importance. One key aspect
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April 13, 2023
Software as Medical Devices (SaMD) Registration: What You Should Know
As technology continues to advance, the use of Software as Medical Devices (SaMD) is becoming more prevalent in the healthcare
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April 13, 2023
BRC Certification Explained for Canadian Businesses
BRC certification is a globally recognized standard for food safety and quality management. In Canada, it has become increasingly important
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April 12, 2023
Top 5 benefits of hiring an Importer of Record for International Trade
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
GRAS List for Food Additives – Your Step-by-Step Guide to Safety
https://youtu.be/wOKeuDAEfss Have you ever wondered what goes into the food you eat every day? Various food additives enhance our food’s
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April 5, 2023
A Guide to Dietary Supplement Regulations
Navigating the complexities of the regulatory requirements for dietary supplements can be daunting. However, by understanding the framework, you can
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April 4, 2023
How to get GRAS Certified faster in 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
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April 3, 2023
What you should know about FDA Approvals for Drugs & Medical Devices
Introduction: FDA approvals can be a complex process, but understanding its important steps can give you insight into how drugs
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March 27, 2023
How to comply with Health Canada Regulations for Medical Devices?
Introduction: Manufacturing and selling medical devices in Canada can be a complex process and requires adherence to Health Canada’s
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March 22, 2023
FDA Registration Renewals: FDA Increases Facility Enforcement
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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March 22, 2023
What to Ask When Registering a Food Facility With the FDA
Quality Smart Solutions offers the best FDA Facility Renewal & Registration services in North America for Medical Devices, Food, and
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March 21, 2023
Understanding the Costs of MDL and MDEL Approvals
The price for an MDEL (Medical Device Establishment Licence) and MDL (Medical Device Licence) in Canada varies according to the
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March 20, 2023
What Companies Need to Understand About GRAS Ingredients
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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March 16, 2023
The Importance of HACCP Consultants for Food Safety
Introduction: Food safety is an important part of any food business. It’s also a complicated one. There are many regulations
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March 15, 2023
Everything You Should Know About the NHP Database (LNHPD)
If you plan to manufacture, import, or sell a natural health product (NHP) in Canada, you need to understand the
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March 14, 2023
How to Choose the Right Importer: 5 Essential Tips
Looking for a quality import service can be a daunting task, but with the right advice and tips, you can
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March 13, 2023
Understanding Class I Medical Devices Approval With Health Canada
What are Class 1 Medical Devices? Class 1 medical devices are the lowest risk category of medical devices, as they
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March 8, 2023
Understanding HACCP: 7 Principles Every Food Business Should Know
The purpose of a Hazard Analysis Critical Control Points (HACCP) plan is to identify and control any hazards that may
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March 7, 2023
GMP Certification Made Simple: What Companies Should Know
Are you considering obtaining GMP (Good Manufacturing Practice) certification for your business? The GMP certification process is crucial for ensuring
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March 1, 2023
Cosmetic Labelling Rules Every Business Should Understand
Introduction: Cosmetic labelling is an essential part of developing and marketing cosmetics. Companies must meet government requirements for labelling, including
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February 24, 2023
Filing a Medical Device 510(k): Timing and Process Explained
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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February 21, 2023
5 Tips to Find the Best Medical Device Regulatory Consultant
Finding the right medical device regulatory consultant is one of the most important steps to ensure your product meets all
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February 15, 2023
How to Achieve GRAS Status for Your Ingredient
If you want to know how to get your ingredient generally recognized as safe (GRAS) by the FDA, you are
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February 12, 2023
What Businesses Need to Know About FDA NAC Guidelines
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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February 8, 2023
How to Navigate Regulatory Requirements for Class III Medical Devices
Introduction: Class 3 medical devices are subject to the highest level of scrutiny and require special attention when it comes
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February 7, 2023
What Does It Mean to be GFSI Certified in an FSMA Environment?
Introduction: FSMA stands for the “Food Safety Modernization Act” which is a set of laws enacted by the US government
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February 1, 2023
GFSI Certification Requirements: How to get GFSI Certified?
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
10 tips to Prepare for the Safe Food License Application Process
Introduction: There are many reasons that you might want to get licensed as a food processor or retail operator. You
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January 25, 2023
Clearing Regulatory Hurdles with a 510K Premarket Notification
Submitting a 510K Premarket Notification is an essential step in the process of getting medical devices approved by the
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January 23, 2023
Your Complete Guide to Getting HACCP Certification
Most regulations require you to follow HACCP principles rather than hold a formal certificate. HACCP certification demonstrates your commitment to
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January 21, 2023
Making the Most of the FDA GRAS Database for Ingredient Safety
If you’re in the food or ingredient industry, you’ve likely heard about the FDA GRAS database. It’s a vital resource
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January 18, 2023
A Practical Guide to Dietary Supplement Labelling Requirements
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
Steps to Achieve GFSI Certification for Your Business
https://youtu.be/XRZ87ifRki0 Ensuring the safety and quality of your food products is crucial for building trust with your customers and expanding
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January 4, 2023
FDA Prior Notice for Food Importers: Unlocking the FDA Guidelines
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
GRAS, NDI, ODI Food Additives & Generally Recognized as Safe GRAS
Introduction Food additives are chemicals added to food products to enhance flavor, texture, or color. Fortunately, there is a list
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December 21, 2022
FDA Food Safety Requirements FSMA Traceability BRC Standards
Introduction: Meeting FSMA compliance requirements is one of the most important things a manufacturer can do to protect their business.
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December 15, 2022
VHP Consulting 5 things about the VHP Notification Program
Introduction Health Canada oversees the importation and sale of Veterinary health products (VHPs) in Canada through the VHP Notification Program.
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December 14, 2022
Explore Health Canada’s Medical Device Regulations (MDL, MDEL & SaMD)
Introduction: Medical devices are an important part of healthcare and play a critical role in the treatment of patients. Medical
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December 8, 2022
GRAS vs NDI: A Simple Guide to Ingredient Compliance
Understanding the differences between GRAS and NDI is essential for any company developing food ingredients or dietary supplements in the
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December 6, 2022
HACCP Implementation: A Practical Guide for Food Businesses
HACCP, which stands for Hazard Analysis and Critical Control Points, is the cornerstone of food safety plans in the food
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November 30, 2022
Safe Quality Food Certification SQF Food Safety Program
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
FDA UDI Labeling Requirements for FDA Class 1 Medical Device in 2023
Introduction: FDA regulations for Class 1 medical devices can be daunting and confusing to navigate. However, with this easier-to-understand
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November 16, 2022
Understanding MDALL/MDEL & How It Transforms Your Business (MDL, MDALL, MDEL Listing)
Navigating medical device regulations set by Health Canada can be challenging. However, knowing the correct classification of your medical device
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November 16, 2022
Medical Device License (MDL MDEL SaMD) Under the Microscope
The Medical Device License is a legal document required to manufacture, sell, and distribute medical devices. The Medical Device Licence
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November 15, 2022
CFIA Enforcement of Nutrition Facts Table & CFIA Labeling Requirements
The Canadian Food Inspection Agency (CFIA) protects Canadians’ health and safety by ensuring food that reaches customers is safe, nutritious, and
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November 9, 2022
FSVP Compliance: Regulatory Assessment Record Keeping 2023
U.S.A RRA FDA Draft Guidance: In a recent U.S. Food and Drug Administration (FDA) draft guidance detailing its implementation
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November 7, 2022
How the Cosmetic Notification Form Works in Canada
Top Canada Cosmetic Regulations Cosmetic Notification Form (CNF) Canada is one of the most popular tourist destinations in the world,
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November 4, 2022
FDA NAC Warning Letter: Targeting N-Acetyl Cysteine (NAC) Supplements
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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November 2, 2022
GRAS Consultants: NDIN or FDA GRAS Certification?
Say you have a new ingredient and are ready to enter the US food market. To ensure this ingredient is
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October 28, 2022
Key Natural Health Product Regulations Canadian Businesses Should Know
The Canadian government has a set of regulations in place for natural health products (NHPs). These regulations help to ensure
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October 18, 2022
Unlock 7 Steps to Verifying Your FSVP in 2023
Foreign Supplier Verification Program (FSVP) Due to the increasingly global nature of today’s industry, an increasing number of businesses are
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October 11, 2022
Inside Scoop MDL VS MDEL & SAMD: Medical Device License Unlocked
The Medical Device License is a legal document that is required for the manufacture, sale, and distribution of medical
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October 5, 2022
Drug Identification Number (DIN) Unlocked Inside Scoop
Many drug industries are working in every country. To sell any OTC drug in Canada is not possible without
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September 29, 2022
FSVP Plan: Levels of FSMA-FSVP Certification
The FSVP Plan is a requirement for many companies to be FSMA compliant. It is the responsibility of the company
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September 22, 2022
How Does FDA Classify Software As A Medical Device (SaMD)?
Nowadays almost all the facets of healthcare are well-equipped with the modern and latest technology tools, including software systems.
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September 15, 2022
Health Canada’s Regulatory Enrollment Process (REP): Top 4 things to know
Industry people and experts considering working with a company not registered with Health Canada should be aware of the regulatory
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September 9, 2022
What are (HACCP & PCP) Requirements for GFSI Certification?
https://youtu.be/XRZ87ifRki0 Since the publishing of the Safe Foods for Canadians Regulations in 2017, there is now a requirement for a
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September 1, 2022
NHPID and NPN: 6 Key Things Businesses Should Know
If you’re selling natural health products in Canada, understanding NHPID and NPN is essential. These tools from Health Canada determine
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August 29, 2022
Natural Health Products (NHP/NPN) Panel Top 19 Questions Answered
1. What is the NHP Licensing Process/what is needed for it? This process involves the submission of a product license
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August 25, 2022
SFCR License and Preventive Control Plans (PCP) Explained
In this blog, we’ll focus on answering your questions about the SFCR License and Preventive Control Plans, including why they
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August 17, 2022
5 Key Reasons Why Drug Identification Numbers Matter
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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August 10, 2022
Regulatory & Market Landscapes of CBD as a NHP
https://youtu.be/veCBMkYUWEU Market Analysis and Overview of CPG Market: Will CBD Products be considered an NHP? The consumer packaged goods (CPG)
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August 5, 2022
Unlock Food Regulations for Food Sales Health Canada & FDA
Do you want to learn about the food regulations for food sales in North America? This could include food facility
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June 27, 2022
Foreign Site Reference Number | FSRN Fruitful Interim Measures
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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June 16, 2022
5 Common Pitfalls When Importing Natural Health Products
As a license holder for Natural Health Products (NHPs), it is your responsibility to be aware of and educated on
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June 15, 2022
Classifying Your Product: Drug, NHP, or Cosmetic?
Learning how to classify your product correctly is one of the most important first steps when entering the Canadian market.
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June 9, 2022
5 Reasons Why Food Labelling Is Important for Your Business
Have you ever looked at a food label and wondered why all that information is there? Labels do more than
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June 7, 2022
Are Toxic Substances Hiding in Your Cosmetics?
What is a cosmetic? Under Section 2 of the Food and Drugs Act, a cosmetic is defined as “any substance
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May 25, 2022
Insider scoop on Selling, Importing & Registering your VHPs in Canada
Introduction: The market for animal and pet products is growing at a rapid pace. With that, there is also a
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May 18, 2022
7 Principles of HACCP: Everything you need to know before building a HACCP plan
What is HACCP? A common question that comes up in regulated industries, such as food manufacturing and processing, is “What
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May 12, 2022
Top 6 Questions to ask about OTC Drugs
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
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April 25, 2022
Learn how to differentiate Dietary Supplement vs NHP Labeling
Introduction Dietary supplements in the USA are very similar to natural health products (NHP regulations) in Canada and many products
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April 18, 2022
Cosmetic Notification Form: A Step-by-Step Guide to Stay Compliant in Canada
Filling out a Cosmetic Notification Form is a required step before selling any cosmetic product in Canada. Health Canada uses
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April 11, 2022
Practical Tips for Getting an NPN Number in Canada
Top 5 Tips to Successfully Secure an NPN Number In order to sell a Natural Health Product (NHP) in Canada
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March 10, 2022
Natural Health Products Quality Characterization Guide for 2022
Natural Health Products have different characterization, identification, quantification, and purity standards that you should know about to ensure the quality
... Read more
February 14, 2022
Top 10 Fruitful Medical Device Development Principles
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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February 9, 2022
Therapeutic vs. Non-Therapeutic Claims Classification Guide
What is a claim? A claim is a representation for sale. It can be presented as “a word, a sentence,
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January 24, 2022
How Your NHP & Drug Products are Reviewed in Canada CTA v.s NDS
In general, all drug products (including over-the-counters and biologics) must be authorized for sale by Health Canada, before they can be
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January 19, 2022
Top Components of your Class III NHP PLA
All Natural Health Products (NHPs) sold in Canada are subject to the Natural Health Products Regulations (NHPR). Natural Health Products
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January 12, 2022
11 Ways MoCRA will enhance FDA Cosmetics Regulations in 2023
Introduction: The Consolidated Appropriations Act, recently passed by the US Congress, incorporates revisions to US cosmetics laws. The Modernization of
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January 11, 2022
How to Legally Sell Medicinal Mushrooms in Canada?
Medicinal Mushrooms in powder, capsule or liquid form can be licensed as Natural Health Product (NHP) in Canada. To sell
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December 24, 2021
Top 9 Cosmetic Compliance Label Components | Health Canada Cosmetics Regulations
What is a Cosmetic? Cosmetics are a part of just about everyone’s life. Every day, most of us use products
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December 17, 2021
Greens and Proteins – Food or NHP?
The classification of Foods and Natural Health Products (NHPs) can be considered difficult, grey, and convoluted. Sometimes even comes down
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December 14, 2021
Registering Products with the EPA – What You Need to Know
The US Environmental Protection Agency (EPA) is saddled with the responsibility to register pesticides in the US. This process is
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November 29, 2021
What to Expect After Submitting Your NPN Application
What to Expect After Submitting an NPN Application In order to sell a Natural Health Product (NHP) in Canada, you
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November 19, 2021
How Pet Food VHP Labels Differ from Human Food Labels in 2022
Pet Foods and Human Food Labels are designed to look similar yet distinct. There are some similar label requirements and
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November 8, 2021
What You Need to Know – Software as a Medical Device (SaMD)
The advancement of technology is rapidly progressing, and the evolution can be observed all around us. As cutting-edge technology becomes
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October 28, 2021
How to Risk Detention of CPG at the border
How to Minimize the Risk of Border Detention Shipping Consumer Packaged Goods As an importer of consumer packaged goods, unanticipated
... Read more
October 25, 2021
Benefits of Routine Inspection of your Licensed Food Facility
Inspection of your food facility will help identify and fix any quality or processing deviations found regarding food safety. Review
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October 20, 2021