Blog
What Are Health Canada’s Rules for Probiotic Health Claims?
Learn Health Canada’s rules for probiotic health claims to ensure compliance and build trust.
... Read more Quality Smart Solutions January 13, 2025
[blog_list]
Blog
MoCRA GMP Delayed Until October 2025: What You Need to Know
Learn about the FDA’s delay of MoCRA GMP to October 2025 and discover how cosmetic companies can prepare for compliance with MoCRA regulations.
... Read more Quality Smart Solutions December 18, 2024
Blog
What Are FDA Medical Device Classes?
Understanding the FDA classification system for medical devices is key to getting your product to market safely and efficiently. Knowing
... Read more Quality Smart Solutions December 17, 2024
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FDA Updates Guidance on Genome-Edited Foods
Discover the FDA’s latest update on voluntary premarket engagement for genome-edited foods and its implications for developers.
... Read more Quality Smart Solutions December 16, 2024
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VHP Representative vs. Importer of Record: Key Differences
Understand the key differences between a VHP Canadian representative and a VHP Importer of Record to ensure regulatory compliance.
... Read more Quality Smart Solutions December 16, 2024
Blog
Health Canada Infant Formula Policy Transition
Learn about Health Canada’s transition strategy for infant formula regulations and ensure compliance before the December 31, 2024, deadline.
... Read more Quality Smart Solutions December 12, 2024
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How to Sell NHPs on Amazon Canada: A Complete Guide
Learn how to sell your NHP on Amazon Canada with this complete guide. From regulations to marketing, get expert tips to maximize sales.
... Read more Quality Smart Solutions December 10, 2024
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Health Canada Fees 2025 Guide
Understand Health Canada’s 2025 fees for NHPs, drugs, medical devices, and cannabis. Stay compliant with Quality Smart Solutions.
... Read more Andrew Parshad December 5, 2024
Blog
Health Canada’s New Nicotine Rules: What’s Changing in 2024
If you’re in the business of nicotine replacement therapies, major regulatory changes are now in place.
... Read more Andrew Parshad November 22, 2024
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FDA 510(k) Pre-Submission: Steps for Medical Device Approval
Are you trying to make sense of the FDA’s 510(k) pre-submission process? You’re not alone. Many companies, especially those new
... Read more Andrew Parshad November 15, 2024
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Canada’s Strict Infant Formula Registration: How Quality Smart Solutions Ensures Compliance and Success
Are you ready to introduce your infant formula to the Canadian market? Health Canada’s stringent regulations ensure the safety, quality,
... Read more Andrew Parshad November 5, 2024
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How to Master FDA Audits for Your Dietary Supplement Facility: A Complete Preparation Guide
Introduction Preparing for an FDA audit can be challenging, especially for dietary supplement manufacturers who must meet stringent Good Manufacturing
... Read more Andrew Parshad November 1, 2024
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Unlocking Health Canada’s ANDS, SNDS, and NDS Pathways: Which is Right for Your Product?
Navigating Health Canada’s drug submission pathways can be daunting. How do you know which pathway—ANDS, SNDS, or NDS—best suits your
... Read more Andrew Parshad November 1, 2024
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Understanding the Differences Between a Health Canada Drug Monograph and Product Monograph – A Must-Know Guide
Navigating Canada’s pharmaceutical regulations can be overwhelming for businesses, especially those dealing in food products, ingredients, and additives. Two pivotal
... Read more Andrew Parshad October 30, 2024
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New Modification to Buffer Zone Affects Food Manufacturers and Suppliers
Simplified Explanation of Changes to Labeling Rules Starting July 2022, food manufacturers and suppliers have been required to display special
... Read more Andrew Parshad October 28, 2024
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Government of Canada Launches Consultation on Plant-Based Egg Alternative Labelling: What Businesses Need to Know
The Canadian Food Inspection Agency (CFIA) has launched a 90-day consultation on proposed guidance for labelling plant-based alternatives to egg
... Read more Andrew Parshad October 25, 2024
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7 Must-Know EFSA Novel Food Regulation Changes for 2025: You Need To Be Ready
Are your novel food products ready for the new European Food Safety Authority (EFSA) regulations? If you’re planning to enter
... Read more Andrew Parshad October 17, 2024
Blog
Breaking News: Health Canada’s New GMP Guide for Natural Health Products – Are You Ready?
Health Canada has just released a draft Good Manufacturing Practices (GMP) guide for natural health products (NHPs), marking a monumental
... Read more Andrew Parshad October 16, 2024
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Understanding the Key Changes to Natural Health Product (NHP) Labeling in Canada
Natural health products (NHPs) are widely used in Canada, ranging from vitamins, minerals, and herbal remedies to probiotics and homeopathic
... Read more Andrew Parshad October 6, 2024
Blog
FDA Considerations Selling Foods in USA
Regulatory Considerations when Selling Foods and Beverages in the United States Selling food products in the United States requires
... Read more Andrew Parshad August 29, 2024
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Health Canada 2024 Changes for Nicotine Replacement Therapies (NRT)
Health Canada 2024 Changes for Nicotine Replacement Therapies (NRT) On August 22, 2024, the Honourable Mark Holland, Minister of Health,
... Read more Andrew Parshad August 21, 2024
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How to Create Health Canada Compliant Food Labels
How to Create Health Canada Compliant Food Labels When entering the Canadian market, designing your food labels correctly is not
... Read more Andrew Parshad August 17, 2024
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Health Canada plans to share document about health products containing CBD this fall
This fall, Health Canada is anticipating sharing a policy consultation document about health products containing (CBD). This proposal has been
... Read more Andrew Parshad August 8, 2024
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Understanding MoCRA and Safety Substantiation Requirements for Cosmetics
The Modernization of Cosmetics Regulation Act (MoCRA) brings significant changes for everyone in the cosmetics industry, from manufacturers to distributors.
... Read more Andrew Parshad July 6, 2024
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Health Canada’s Regulatory Plan 2024-26: Proposed Amendments to NHP and Non-Prescription Drugs
Health Canada has unveiled its Forward Regulatory Plan for 2024-2026, outlining significant amendments to the Natural Health Products Regulations and
... Read more Andrew Parshad July 6, 2024
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Health Canada 2024 Drug Establishment Licensing (DEL) Update
Health Canada is introducing a new plan to modernize the Drug Establishment Licensing (DEL) framework over the coming years. This
... Read more Andrew Parshad July 3, 2024
Blog
Launch Your Foods, Cosmetics, NHPs, & Pet Products on Amazon Canada: Compliance FAQs
We understand the impact of changing Amazon Canada regulations on your business – and how non-compliance can hurt you. Q:
... Read more Quality Smart Solutions May 3, 2024
Blog
FDA Regulates Lab-Developed Tests for Safety
FDA (U.S) has recently revised its regulatory framework for laboratory-developed tests (LDTs). These in vitro diagnostic products (IVDs) are critical
... Read more Quality Smart Solutions May 3, 2024
Blog
How to get an NHP Licence for Nicotine Pouches in Canada?
Remember the days of gumming patches, sucking lozenges, and hiding bulky vaporizers? Nicotine pouches, those discreet little packets promising rapid
... Read more Andrew Parshad January 7, 2024
Blog
FDA Updates Yogurt Standard: Key Changes for Manufacturers
Attention all yogurt makers, big and small! The U.S. Food and Drug Administration (FDA) has finalized changes to the standard
... Read more Andrew Parshad January 2, 2024
Blog
Navigating GRAS Panels: A Guide to Best Practices
When it comes to introducing new substances into the world of food and dietary supplements, ensuring safety is paramount. The
... Read more Andrew Parshad November 6, 2023
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Navigating the Regulatory Landscape: Understanding FDA FURLS, FDA Approved, and FDA Registered Medical Devices
Introduction The process of bringing a medical device to market in the United States involves stringent regulations imposed by the
... Read more Andrew Parshad November 2, 2023
Blog
What is a CCP in HACCP? Understanding Critical Control Points and Regulatory Compliance
https://youtu.be/dVbug89UHBA Introduction In food safety management, Hazard Analysis and Critical Control Points (HACCP) is a systematic approach that ensures the
... Read more Andrew Parshad November 2, 2023
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Expert guide to GRAS Pathways: GRAS Notice vs. Self-Affirmed
Navigating the intricate landscape of food and food additive regulation in the United States involves understanding the GRAS concept – “Generally
... Read more Andrew Parshad October 31, 2023
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From A to Z: Everything You Need to Understand About GRAS Substances
Are you curious about GRAS substances? Look no further! This comprehensive guide takes you from A to Z, covering everything
... Read more Andrew Parshad October 26, 2023
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Everything businesses should know about the Supplemented Foods Facts Table (SFFT)
Introducing the Supplemented Foods Facts Table (SFFT), your go-to guide for navigating the ever-changing world of supplemented foods. With consumer
... Read more Andrew Parshad October 25, 2023
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Medical Device Compliance in Canada: A Guide for Manufacturers
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
... Read more Andrew Parshad October 18, 2023
Blog
Selling Food in Canada: Navigating the Requirements for Conventional and Supplemented Products
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
... Read more Andrew Parshad October 12, 2023
Blog
FDA 510(k) Clearance: Unveiling the Medical Device Regulations.
Navigating the intricate world of medical devices can be daunting, especially when it comes to ensuring their safety and effectiveness.
... Read more Andrew Parshad October 11, 2023
Blog
Everything to know about Drug Registration & NDC drug number
The pharmaceutical industry ensures public health by developing, manufacturing, and distributing safe and effective medications. For any drug to be
... Read more Andrew Parshad October 4, 2023
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Navigating the Regulatory Seas: How Experts Ensure Your Medical Devices Set Sail Smoothly
Introduction In the ever-changing world of medical device manufacturing, ensuring your product complies with regulations is akin to navigating stormy
... Read more Andrew Parshad September 29, 2023
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510k Submission Guidance: Unpacking the 510k Requirements
Introduction In the world of medical devices, ensuring patient safety and efficacy is paramount. The 510(k) submission process is a
... Read more Andrew Parshad September 28, 2023
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Navigating French Language Labeling Requirements in Canada: A Guide for Food Manufacturers
Introduction: As a food manufacturer in Canada, ensuring that your product labels comply with Health Canada’s regulations is crucial for
... Read more Andrew Parshad September 27, 2023
Blog
Why is it crucial to avoid FDA Warning Letters for dietary supplements and health products?
As a business owner operating in dietary supplements and health products, you are undoubtedly aware of the ever-evolving regulatory
... Read more Andrew Parshad September 27, 2023
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Everything businesses should know about submitting a 30-Day Pre-Market Notification and Structure-Function Claims
https://youtu.be/MlufAYFqQ1s In dietary supplements, navigating the intricate regulatory landscape is a challenging yet indispensable aspect of launching your product. Submitting
... Read more Andrew Parshad September 26, 2023
Blog
Selling Your Food Products in the USA: A Guide for Food Business Owners
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
... Read more Andrew Parshad September 19, 2023
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Navigating Health Canada’s NPN Application Process: A Comprehensive Guide
Introduction: Health Canada’s Natural Products Number (NPN) application process is vital for manufacturers and distributors of natural health products (NHPs)
... Read more Andrew Parshad September 19, 2023
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How to prepare and submit an eStar 510k Submission as of October 1st
Introduction: Staying up-to-date with the latest regulations and tools is crucial in medical device submissions. As of June 9, 2023,
... Read more Andrew Parshad September 15, 2023
Blog
Requirements to sell Dietary Supplements in the United States
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
... Read more Andrew Parshad September 14, 2023
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A Comprehensive Guide to FSVP Rules and Records for Importers
For importers in the global food trade, ensuring the safety and compliance of imported products is a top priority. The
... Read more Andrew Parshad September 13, 2023
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Inside Scoop: Draft Guidance for MLMD Application Submissions
*This summary of Health Canada’s guidance document provides compliance details for manufacturers submitting a new or amended application. Under the
... Read more Andrew Parshad September 11, 2023
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FSMA Assurance: Safeguarding Food Safety at Every Step
https://youtu.be/T3pLp1dF08Y The Food Safety Modernization Act (FSMA) Made Simple Imagine a world where preventing food-related illnesses is more important than
... Read more Andrew Parshad September 9, 2023
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FSVP Planning: Everything you should know before choosing an FSVP Agent for Import/Export
https://youtu.be/T3pLp1dF08Y Introduction: In the intricate world of global trade, ensuring the safety and compliance of imported and exported food products
... Read more Andrew Parshad September 7, 2023
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Staying Ahead of the Game: Key Insights on the Latest Requirements for New Drug Submissions
From FDA guidelines to global regulatory standards, understanding the nuances of each requirement is essential to ensure a timely
... Read more Andrew Parshad September 6, 2023
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Demystifying GHP and GMP Regulatory Food Safety Audits: Why They Matter
In the realm of food production and processing, safety is paramount. Ensuring our food is free from contaminants and meets
... Read more Andrew Parshad September 5, 2023