Learn how to get an NPN for sports supplements in Canada and ensure full compliance with Health Canada’s Natural Health Products Regulations.
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Stay compliant with FDA drug establishment and listing renewal requirements before December 31, 2025. Learn key steps and how to file correctly.
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Learn how CETA allows EU exporters to sell food supplements in Canada tariff free and what regulatory steps are required for compliance.
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Learn the key differences between importing human food and animal food into Canada, including CFIA and Health Canada requirements.
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Learn how an expert panel supports GRAS determinations by ensuring scientific credibility, safety, and FDA alignment.
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Learn how to get GRAS status for an enzyme and meet FDA safety requirements through proper evaluation, expert review, and documentation.
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Learn how to prepare and submit an EFSA novel food application and gain market access in the EU.
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Learn how clinical studies support EFSA novel food applications, ensuring your product’s safety, efficacy, and market approval.
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FDA confirms NMN is lawful in dietary supplements after industry pressure. Learn what this means for your business and compliance strategy.
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Learn how to prepare Instructions for Use for FDA submission for medical devices. Stay compliant with FDA requirements and international standards.
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Discover the truth about SR&ED eligibility myths and learn what actually qualifies for credits and refunds under Canada’s SR&ED program.
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What is SR&ED and how does it work in Canada? Learn about eligibility, benefits, and how to maximize your SR&ED tax credit with expert guidance.
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Discover 10 best practices to achieve GRAS status while staying FDA compliant. Follow expert tips for smooth ingredient compliance.
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Explore the 7 sections of a GRAS dossier and learn how they ensure ingredient compliance, safety, and FDA acceptance.
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Learn what GMP training is, why it matters, and who needs it. Explore GMP fundamentals and compliance requirements for Health Canada and FDA.
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Learn how to register a private label medical device with Health Canada. Follow this step-by-step guide to ensure regulatory compliance.
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Learn how to avoid site license renewal refusals or suspensions and meet Health Canada compliance expectations.
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Learn how CFIA’s feed regulatory modernization impacts your compliance. Stay ahead with key changes and expert guidance.
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When preparing to launch a medical device in the U.S., one of the first and most important decisions
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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.
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Learn how professional audits support Health Canada compliance, minimize risks, and keep your business inspection-ready.
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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.
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Learn how to get an NPN for hydration products in Canada and ensure full Health Canada compliance.
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FDA’s FY 2025 OMUFA fees are due June 22 for OTC drug manufacturers and contract facilities. Learn what this means and how to stay compliant.
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Understand the GRAS process for human food vs. animal feed and how to stay compliant with FDA regulations.
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Learn the key differences between traditional cosmetics and cosmeceuticals to ensure regulatory compliance in Canada and the U.S.
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Learn what an SFCR importer of record is and how CARM changes affect food importers in Canada. Stay compliant with expert support.
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Learn what MDL and MDEL mean, how they differ, and how to stay compliant with Health Canada regulations.
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Learn what to do if you’re struggling with the GRAS compliance process. Follow these tips to avoid delays and meet FDA standards.
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Understand how to stay compliant with FDA and Health Canada rules for eczema products. Learn how to properly classify and register your product.
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Learn the key differences between FDA and Health Canada cosmetic compliance to meet regulatory requirements and avoid costly setbacks.
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Learn how to prepare a food additive submission for Health Canada to ensure compliance and avoid costly delays.
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Learn how to avoid Amazon Canada cosmetic delisting by meeting Health Canada requirements and maintaining compliance.
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Learn the difference between functional foods and Natural Health Products in Canada, and how to classify your product correctly.
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What is NPN? Learn how to get approval for your natural health product and stay compliant with Canadian regulations.
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Learn how MDSAP helps meet Health Canada requirements and streamline audits for medical device compliance.
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Understand food and supplement labeling differences between Canada and the US to stay compliant and avoid costly delays.
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Avoid FDA medical device submission errors and improve your approval chances with these expert tips.
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Health Canada updated cannabis regulations on March 12, 2025. Learn about compliance, cost-saving benefits, and industry impact.
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The FDA may eliminate self-affirmed GRAS. Learn how this change could affect food ingredient approvals and what steps you should take now.
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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.
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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.
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Discover the key steps to obtaining TGA approval for new substances in listed medicines. Ensure compliance and streamline your application.
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Learn how Bill 96 changes bilingual labelling requirements in Quebec and impacts businesses nationwide.
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Learn how to navigate the FDA approval process for shilajit in 5 simple steps. Follow our expert guide for a smoother regulatory journey.
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Learn Health Canada’s rules for probiotic health claims to ensure compliance and build trust.
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The U.S. Food and Drug Administration (FDA) recently announced a uniform compliance date for food labeling regulations. This update establishes
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Learn about the FDA’s delay of MoCRA GMP to October 2025 and discover how cosmetic companies can prepare for compliance with MoCRA regulations.
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Understanding the FDA classification system for medical devices is key to getting your product to market safely and efficiently. Knowing
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Understand the key differences between a VHP Canadian representative and a VHP Importer of Record to ensure regulatory compliance.
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Learn about Health Canada’s transition strategy for infant formula regulations and ensure compliance before the December 31, 2024, deadline.
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Learn how to sell your NHP on Amazon Canada with this complete guide. From regulations to marketing, get expert tips to maximize sales.
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Understand Health Canada’s 2025 fees for NHPs, drugs, medical devices, and cannabis. Stay compliant with Quality Smart Solutions.
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If you’re in the business of nicotine replacement therapies, major regulatory changes are now in place.
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Are you trying to make sense of the FDA’s 510(k) pre-submission process? You’re not alone. Many companies, especially those new
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Learn how to navigate Canada’s strict infant formula registration process and ensure full compliance with Health Canada’s regulations.
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Introduction Preparing for an FDA audit can be challenging, especially for dietary supplement manufacturers who must meet stringent Good Manufacturing
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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.
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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.
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Simplified Explanation of Changes to Labeling Rules Starting July 2022, food manufacturers and suppliers have been required to display special
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The Canadian Food Inspection Agency (CFIA) has launched a 90-day consultation on proposed guidance for labelling plant-based alternatives to egg
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If you’re planning to enter the European market in 2025, significant updates to the EFSA novel food regulatory framework are on the horizon, effective from February 1, 2025.
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Health Canada has just released a draft Good Manufacturing Practices (GMP) guide for natural health products (NHPs), marking a monumental
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Natural health products (NHPs) are widely used in Canada, ranging from vitamins, minerals, and herbal remedies to probiotics and homeopathic
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Regulatory Considerations when Selling Foods and Beverages in the United States Selling food products in the United States requires
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Health Canada 2024 Changes for Nicotine Replacement Therapies (NRT) On August 22, 2024, the Honourable Mark Holland, Minister of Health,
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Learn how to meet Health Canada’s food labeling requirements in Canada, from bilingual rules to front-of-pack nutrition symbols.
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This fall, Health Canada is anticipating sharing a policy consultation document about health products containing (CBD). This proposal has been
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Learn FDA MoCRA requirements for cosmetics, including registration, labeling, GMP, and safety substantiation. Stay compliant and protect your brand.
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Health Canada has unveiled its Forward Regulatory Plan for 2024-2026, outlining significant amendments to the Natural Health Products Regulations and
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Health Canada is introducing a new plan to modernize the Drug Establishment Licensing (DEL) framework over the coming years. This
... Read moreWe understand the impact of changing Amazon Canada regulations on your business – and how non-compliance can hurt you. Q:
... Read moreFDA (U.S) has recently revised its regulatory framework for laboratory-developed tests (LDTs). These in vitro diagnostic products (IVDs) are critical
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Remember the days of gumming patches, sucking lozenges, and hiding bulky vaporizers? Nicotine pouches, those discreet little packets promising rapid
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Attention all yogurt makers, big and small! The U.S. Food and Drug Administration (FDA) has finalized changes to the standard
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When it comes to introducing new substances into the world of food and dietary supplements, ensuring safety is paramount. The
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This article explores the differences between these designations and provides insights into how to obtain the necessary licenses for medical devices.
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Learn about Critical Control Points (CCPs) in HACCP, their role in food safety, and how to stay compliant with global regulations.
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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.
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Learn what GRAS substances are, how they’re used, and how to stay compliant. Read this guide to understand food, drug, and cosmetic regulations.
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Introducing the Supplemented Foods Facts Table (SFFT), your go-to guide for navigating the ever-changing world of supplemented foods. With consumer
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Discover how regulatory consultants help medical device manufacturers thrive in Canada’s complex compliance landscape: real-life insights.
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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
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Navigating the intricate world of medical devices can be daunting, especially when it comes to ensuring their safety and effectiveness.
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Learn how drug registration works in the U.S. and why the National Drug Code (NDC) number matters for compliance, billing, and patient safety.
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Introduction In the ever-changing world of medical device manufacturing, ensuring your product complies with regulations is akin to navigating stormy
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Introduction In the world of medical devices, ensuring patient safety and efficacy is paramount. The 510(k) submission process is a
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Introduction: As a food manufacturer in Canada, ensuring that your product labels comply with Health Canada’s regulations is crucial for
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As a business owner operating in dietary supplements and health products, you are undoubtedly aware of the ever-evolving regulatory
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https://youtu.be/MlufAYFqQ1s In dietary supplements, navigating the intricate regulatory landscape is a challenging yet indispensable aspect of launching your product. Submitting
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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 moreLearn how to obtain an NPN license for your natural health product in Canada with these simple steps. Stay compliant with Health Canada regulations.
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Introduction: Staying up-to-date with the latest regulations and tools is crucial in medical device submissions. As of June 9, 2023,
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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.
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For importers in the global food trade, ensuring the safety and compliance of imported products is a top priority. The
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Discover the secrets behind successful Machine Learning-Enabled Medical Device (MLMD) development, risk management, and more.
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The Food Safety Modernization Act (FSMA) Made Simple Imagine a world where preventing food-related illnesses is more important than dealing
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https://youtu.be/T3pLp1dF08Y Introduction: In the intricate world of global trade, ensuring the safety and compliance of imported and exported food products
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From FDA guidelines to global regulatory standards, understanding the nuances of each requirement is essential to ensure a timely
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In the realm of food production and processing, safety is paramount. Ensuring our food is free from contaminants and meets
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