FDA 510(k) pre-submissions vs PMA: Whatâs the difference?
When preparing to launch a medical device in the U.S., one of the first and most important decisions
... Read more June 23, 2025
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[blog_list]
How to Strengthen Operations with GMP Training
If you work in the life sciences industry, you’ve likely heard of GMP, Good Manufacturing Practice. It’s a fundamental part of producing safe, effective, and high-quality products.
... Read more June 20, 2025
How Audits Help You Stay Compliant with Health Canada
When it comes to audits related to Health Canada requirements, staying compliant is about more than checking off a list.
... Read more June 19, 2025
Pet Supplements or Veterinary Health Products? USA vs Canada
Compare pet supplements vs veterinary health products to stay compliant in the U.S. and Canada. Know the rules and get expert help to launch successfully.
... Read more June 11, 2025
How to get an NPN for hydration products in Canada
Learn how to get an NPN for hydration products in Canada and ensure full Health Canada compliance.
... Read more June 5, 2025
FY 2025 OMUFA Fees Due June 2: What You Need to Know
FDAâs FY 2025 OMUFA fees are due June 22 for OTC drug manufacturers and contract facilities. Learn what this means and how to stay compliant.
... Read more June 1, 2025
How the GRAS Process Differs for Human Food and Animal Feed
Understand the GRAS process for human food vs. animal feed and how to stay compliant with FDA regulations.
... Read more May 31, 2025
Traditional Cosmetics vs. Cosmeceuticals: Whatâs the Difference?
Learn the key differences between traditional cosmetics and cosmeceuticals to ensure regulatory compliance in Canada and the U.S.
... Read more May 28, 2025
What Is an SFCR Importer of Record?
Learn what an SFCR importer of record is and how CARM changes affect food importers in Canada. Stay compliant with expert support.
... Read more May 24, 2025
How to Navigate MDL and MDEL Licensing in Canada
Learn what MDL and MDEL mean, how they differ, and how to stay compliant with Health Canada regulations.
... Read more May 21, 2025
Struggling With GRAS Compliance? Here’s What to Do
Learn what to do if you’re struggling with the GRAS compliance process. Follow these tips to avoid delays and meet FDA standards.
... Read more May 15, 2025
Navigating FDA and Health Canada Rules for Eczema Products
Understand how to stay compliant with FDA and Health Canada rules for eczema products. Learn how to properly classify and register your product.
... Read more May 6, 2025
FDA vs Health Canada Cosmetic Compliance
Learn the key differences between FDA and Health Canada cosmetic compliance to meet regulatory requirements and avoid costly setbacks.
... Read more May 1, 2025
How to Prepare a Food Additive Submission for Health Canada
Learn how to prepare a food additive submission for Health Canada to ensure compliance and avoid costly delays.
... Read more April 25, 2025
How to Avoid Amazon Canada Cosmetic Delisting
Learn how to avoid Amazon Canada cosmetic delisting by meeting Health Canada requirements and maintaining compliance.
... Read more April 22, 2025
What’s the Difference Between Functional Foods and NHPs?
Learn the difference between functional foods and Natural Health Products in Canada, and how to classify your product correctly.
... Read more April 8, 2025
What Is an NPN and Why It Matters in Canada?
What is NPN? Learn how to get approval for your natural health product and stay compliant with Canadian regulations.
... Read more April 6, 2025
What Is MDSAP and Why Does It Matter?
Learn how MDSAP helps meet Health Canada requirements and streamline audits for medical device compliance.
... Read more April 3, 2025
Food and Supplement Labeling: Canada vs US Requirements
Understand food and supplement labeling differences between Canada and the US to stay compliant and avoid costly delays.
... Read more March 31, 2025
Avoid FDA Medical Device Submission Errors With These Tips
Avoid FDA medical device submission errors and improve your approval chances with these expert tips.
... Read more March 18, 2025
Health Canada Announces Amendments to Cannabis Regulations
Health Canada updated cannabis regulations on March 12, 2025. Learn about compliance, cost-saving benefits, and industry impact.
... Read more March 16, 2025
Self-Affirmed GRAS May End – What It Means for You
The FDA may eliminate self-affirmed GRAS. Learn how this change could affect food ingredient approvals and what steps you should take now.
... Read more March 12, 2025
Health Canada Reviews CBD as an NHP in New Consultation
Health Canada is conducting a public consultation on CBD regulations for NHPs, exploring a pathway to allow non-prescription CBD products under the NHPR. This consultation opened on March 7, 2025, and will close on June 5, 2025.
... Read more March 7, 2025
GRAS in Pet Food: A Guide to Ingredient Compliance
Understanding GRAS in pet food is crucial for compliance. This guide explains what GRAS is, how it works, and why it matters for your business.
... Read more February 5, 2025
How to Get TGA Approval for New Substances in Listed Medicines
Discover the key steps to obtaining TGA approval for new substances in listed medicines. Ensure compliance and streamline your application.
... Read more January 30, 2025
How Bill 96 Impacts Bilingual Labelling in Canada
Learn how Bill 96 changes bilingual labelling requirements in Quebec and impacts businesses nationwide.
... Read more January 29, 2025
5 Steps to Navigate FDA Compliance for Shilajit
Learn how to navigate the FDA approval process for shilajit in 5 simple steps. Follow our expert guide for a smoother regulatory journey.
... Read more January 24, 2025
What Are Health Canadaâs Rules for Probiotic Health Claims?
Learn Health Canadaâs rules for probiotic health claims to ensure compliance and build trust.
... Read more January 13, 2025
FDA Sets 2028 Compliance Date for Food Labels
The U.S. Food and Drug Administration (FDA) recently announced a uniform compliance date for food labeling regulations. This update establishes
... Read more January 10, 2025
MoCRA GMP Delayed Until October 2025: What You Need to Know
Learn about the FDAâs delay of MoCRA GMP to October 2025 and discover how cosmetic companies can prepare for compliance with MoCRA regulations.
... Read more December 18, 2024
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 December 17, 2024
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 December 16, 2024
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 December 12, 2024
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 December 10, 2024
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 December 5, 2024
Health Canadaâs New Nicotine Rules: Whatâs Changing in 2024
If youâre in the business of nicotine replacement therapies, major regulatory changes are now in place.
... Read more November 22, 2024
FDA 510(k) Pre-Submission: Steps for Medical Device Approval
Are you trying to make sense of the FDAâs 510(k) pre-submission process? You’re not alone. Many companies, especially those new
... Read more November 15, 2024
How to Ensure Compliance with Canadaâs Infant Formula Registration
Learn how to navigate Canadaâs strict infant formula registration process and ensure full compliance with Health Canadaâs regulations.
... Read more November 5, 2024
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 November 1, 2024
Health Canadaâs NDS, SNDS, and ANDS Pathways: Which One Is Right for You?
This article breaks down the 3 main pathways for drug submission in Canada: NDS, SNDS & ANDS. Choose the right one for faster market & lower cost.
... Read more November 1, 2024
Health Canada’s Drug vs Product Monograph: Key Differences
Two pivotal documents in this regulatory landscape, the Health Canada Drug Monograph and Product Monograph, hold distinct roles and purposes. Keep reading to learn more.
... Read more October 30, 2024
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 October 28, 2024
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 October 25, 2024
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 October 17, 2024
Breaking News: Health Canadaâs 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 October 16, 2024
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 October 6, 2024
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 August 29, 2024
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 August 21, 2024
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 August 17, 2024
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 August 8, 2024
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 July 6, 2024
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 July 6, 2024
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 July 3, 2024
Launch Your Foods, Cosmetics, NHPs, & Pet Products on Amazon Canada: Compliance FAQs
We understand the impact of changing Amazon Canada regulations on your business â and how non-compliance can hurt you. Q:
... Read more May 3, 2024
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 May 3, 2024
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 January 7, 2024
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 January 2, 2024
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 November 6, 2023
Understanding FDA FURLS, FDA Approved, and FDA Registered Medical Devices
This article explores the differences between these designations and provides insights into how to obtain the necessary licenses for medical devices.
... Read more November 2, 2023
What Are Critical Control Points (CCPs) in HACCP?
Learn about Critical Control Points (CCPs) in HACCP, their role in food safety, and how to stay compliant with global regulations.
... Read more November 2, 2023
GRAS Notice vs. Self-Affirmed GRAS: Which Is Best?
Learn the key differences between GRAS Notice and Self-Affirmed GRAS to ensure FDA compliance and food safety. Find the best approach for your product.
... Read more October 31, 2023
What Are GRAS Substances? A Complete Guide
Learn what GRAS substances are, how theyâre used, and how to stay compliant. Read this guide to understand food, drug, and cosmetic regulations.
... Read more October 26, 2023
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 October 25, 2023
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 October 18, 2023
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 October 12, 2023
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 October 11, 2023
Drug Registration and NDC Number in the U.S.: A Complete Guide
Learn how drug registration works in the U.S. and why the National Drug Code (NDC) number matters for compliance, billing, and patient safety.
... Read more October 4, 2023
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 September 29, 2023
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 September 28, 2023
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 September 27, 2023
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 September 27, 2023
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 September 26, 2023
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 September 19, 2023
How to Obtain an NPN License for Your Natural Health Product in Canada
Learn how to obtain an NPN license for your natural health product in Canada with these simple steps. Stay compliant with Health Canada regulations.
... Read more September 19, 2023
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 September 15, 2023
10 Steps to Sell Dietary Supplements in the U.S.
Learn how to legally sell dietary supplements in the U.S. by following FDA regulations, labeling requirements, and ingredient safety standards. Stay compliant and grow your business.
... Read more September 14, 2023
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 September 13, 2023
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 September 11, 2023
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 September 9, 2023
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 September 7, 2023
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 September 6, 2023
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 September 5, 2023
Navigating the FDA Registration 510K Process: Your guide to getting your Medical Device to market
Introduction: So you’ve got a game-changing medical device that could reshape healthcare as we know it. Amazing! But before
... Read more August 30, 2023
Navigating HACCP Regulations: A Comprehensive Guide for Industry Compliance
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
... Read more August 28, 2023
IOR Compliance USA: Navigating Regulations and Tax Responsibilities
https://youtu.be/mWaBQzsa1_M Introduction: Navigating international trade regulations and the intricacies of Importer of Record (IOR) compliance and taxes can be complex.
... Read more August 24, 2023
Decoding Food Labeling Regulations: Unveiling Requirements on Food Labels
Understanding Food Labels: A Simple Guide Food labels are more than just ingredient stickers on packaging; they are a key
... Read more August 23, 2023
Del Health Canada: Roles & responsibilities in protecting Canadians
Del Health Canada is a crucial regulatory body responsible for ensuring the safety and effectiveness of drugs and medical devices
... Read more August 23, 2023
Everything you should know about Health Canada Controlled Substances
Health Canada, the Canadian federal health department, oversees the regulation of controlled substances in Canada. Controlled substances are regulated due
... Read more August 22, 2023
Quality Management Systems (QMS): Impact of Quality Assurance & Quality Control
Quality Management Systems (QMS) are an essential part of the life sciences healthcare industry, and many people need clarification on
... Read more August 18, 2023
Your comprehensive guide to GRAS Applications for peak efficiency and success
Are you ready to take your business to new heights? Look no further. In this comprehensive guide, we will unlock
... Read more August 16, 2023
Everything you should i know about Health Canada product monographs
Health Canada publishes product monographs to describe a product’s health risks, benefits, and performance. Product monographs are for health products
... Read more August 15, 2023
Benefits & requirements of using a medical device MDEL Import Agent
Using a medical device import agent can offer several benefits, especially if you are navigating the complex process of
... Read more August 14, 2023
FDA Facility Registration & Renewals (FDA Medical Device, Food & Drugs)
Quality Smart Solutions offers the best FDA Facility Renewal & Registration services in North America for Medical Devices, Food, and
... Read more August 13, 2023
EFSA novel food submission, procedures & food panel guidance
Introduction: The European Food Safety Authority (EFSA) provides regulatory guidance and oversees the approval process for novel foods in the
... Read more August 11, 2023
Demystifying the Medical Device Regulatory Process: A guide for manufacturers
Navigating the complex medical device regulatory process can often feel like decoding a cryptic language. Manufacturers grapple with an intricate
... Read more August 10, 2023
Everything to know about the GRAS Generally Recognized as Safe Database
Food manufacturers everywhere are willing to jump through hurdles to receive their GRAS Notifications and access to the generally recognized
... Read more August 9, 2023
US Cosmetic Regulatory Requirements for Manufacturers (MoCRA Regulations)
https://youtu.be/uuXA8yHrrZc Introduction: Behold the âModernization of Cosmetic Regulation Act of 2022â that President Biden signed on December 29, 2022. This
... Read more August 9, 2023
Navigating the process: your guide to obtaining a Natural Health Product License
Are you looking to bring your natural health product to market? Navigating the process of obtaining a license can be
... Read more August 2, 2023
Navigating the regulatory landscape: Understanding the Importance of a Generally Recognized as Safe Database
In todayâs rapidly evolving regulatory landscape, businesses face many challenges regarding ensuring compliance and product safety. One crucial aspect often
... Read more August 2, 2023
Demystifying Health Canada’s MDALL: Everything you should know about MDALL registration for medical devices
Are you a medical device manufacturer looking to enter the Canadian market? Navigating the regulatory landscape can be overwhelming,
... Read more August 1, 2023
