Regulatory Insights Blog
Stay informed on FDA and Health Canada regulatory updates, compliance tips, and industry best practices.
FDA Certificate to Foreign Government (CFG): How It Opens Doors to Global Markets
Everything exporters need to know about FDA's Certificate to Foreign Government program — what it is, which certificate types exist, how to apply, and how CFGs help U.S. companies sell FDA-regulated products worldwide.
FDA Initial Importer Requirements: What Every Importer of FDA-Regulated Products Must Know
A complete guide to FDA Initial Importer obligations for medical devices, drugs, and food products — covering registration, labeling, recordkeeping, adverse event reporting, and import entry procedures.
How to Get a Health Canada Natural Health Product (NHP) Licence
A step-by-step guide to obtaining a Natural Product Number (NPN) from Health Canada — covering product licence applications, site licences, evidence requirements, and labeling standards.
MoCRA Facility Registration & Product Listing: 2025 Compliance Guide
The Modernization of Cosmetics Regulation Act introduced the most significant cosmetics reform in decades. Here's what your business must do to stay compliant in 2025.
FSMA Preventive Controls: A Compliance Guide for Food and Supplement Manufacturers
Everything food and dietary supplement manufacturers need to know about FDA's FSMA Preventive Controls for Human Food rule — food safety plans, hazard analysis, and FDA facility registration.
UDI Compliance: A Complete Guide for Medical Device Manufacturers
Everything you need to know about FDA's Unique Device Identification system — labeling requirements, GUDID submission, and compliance deadlines by device class.
Cosmetic Labeling Requirements: FDA vs. Health Canada Side-by-Side
A practical comparison of U.S. and Canadian cosmetic labeling rules — required elements, ingredient declaration formats, bilingual obligations, and label review tips.
DSHEA Compliance 101: What Dietary Supplement Companies Must Know
A practical guide to FDA's Dietary Supplement Health and Education Act — covering facility registration, cGMP requirements, labeling rules, NDI notifications, and structure/function claims.
FDA Inspections vs. MDSAP: Key Differences Every Device Maker Must Know
A practical comparison of traditional FDA facility inspections and the Medical Device Single Audit Program — and how MDSAP participation can reduce your regulatory burden.
Building a Safety Substantiation File for Your Cosmetic Product
MoCRA requires cosmetic products to be safe and have adequate substantiation of safety. Here's what your safety file must contain and how to build one that satisfies FDA.
Health Canada Cosmetic Hotlist: What Every Brand Needs to Know
Health Canada's Cosmetic Ingredient Hotlist prohibits or restricts hundreds of substances in cosmetics. Here's how to screen your formulas and avoid costly reformulations.
Medical Device Labeling Under 21 CFR Part 801: What Must Be on Your Label
A practical breakdown of FDA's mandatory labeling requirements for medical devices — including required elements, format rules, and common deficiencies that trigger 483 observations.
MoCRA Adverse Event Reporting for Cosmetics: What Companies Must Do
MoCRA introduced mandatory adverse event reporting for cosmetics sold in the U.S. Here's what qualifies as a serious adverse event, the reporting timeline, and how to set up your system.
ISO 13485 vs. FDA QMSR: What Changes Under the New Quality System Rule
FDA's Quality Management System Regulation (QMSR) aligns 21 CFR Part 820 with ISO 13485:2016. Here's what manufacturers need to know about the transition and key differences.
How to Respond to FDA Form 483 Observations Effectively
A step-by-step guide to crafting a strong FDA Form 483 response — timelines, structure, CAPA requirements, and common mistakes that escalate observations into warning letters.
510(k) vs. De Novo vs. PMA: Choosing the Right FDA Premarket Pathway
A comprehensive comparison of FDA's three premarket submission pathways for medical devices — with decision criteria and timeline expectations.
Health Canada Medical Device Licence (MDL): A Step-by-Step Guide
How to obtain a Medical Device Licence for Class II, III, and IV devices in Canada — application requirements, technical documentation, and common pitfalls to avoid.
MoCRA 2024 Compliance Checklist: What Every Cosmetics Company Must Do Now
A step-by-step guide to meeting FDA's MoCRA requirements — facility registration, product listing, labeling, safety substantiation, and adverse event reporting.
OTC Monograph Reform Under the CARES Act: What Manufacturers Need to Know
How the CARES Act changed OTC drug regulation from a rulemaking process to an administrative order system — and what it means for manufacturers.
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