How to Determine the Right Regulatory Pathway for a New Product in the US and Canada
This guide outlines how product classification, intended use, and risk determine FDA and Health Canada regulatory pathways. It emphasizes accurate…
7 Assumptions That Create Compliance Risk in Regulated Product Launches (and How to Fix Them)
Product launches risk delays or rejection by assuming compliance is a last-minute checklist. Avoid this by understanding regulations, planning realistic…
From Submission to Surveillance: How Quality Systems Drive Regulatory Success
A robust QMS ensures regulatory submission success and ongoing compliance by aligning with GMP, ISO 13485, risk management, data integrity,…
How to Align Labeling, Claims, and Evidence for Regulated Product Compliance in the US and Canada
Align labeling, claims, and evidence per FDA and Health Canada rules to avoid delays and enforcement. Use substantiation matrices, clinical…
Pre-Market Regulatory Gap Analysis: What to Cover Before US and Canadian Market Entry
Conduct a thorough regulatory gap analysis addressing US FDA and Health Canada requirements, labeling, claims substantiation, risk management (ISO 14971),…
How to Get an NPN in Canada: A Step-by-Step Guide to Natural Health Product Licensing
This guide details the complex Canadian NPN licensing process, covering product classification, evidence requirements, timelines, GMP compliance, and labeling. Arora…
Choosing the Right Regulatory Pathway in the US and Canada: A Practical Guide for Pharma, Medical Devices, NHPs, and Cosmetics
This guide clarifies US FDA and Health Canada regulatory pathways for pharma, devices, NHPs, and cosmetics to ensure correct classification,…
Health Canada Natural Health Products: A Practical Guide to NPN Licensing, Site Compliance, and Labeling
This guide details Health Canada's Natural Health Product regulations, covering NPN licensing, site compliance, and labeling. Arora 297 Consultancy offers…
Post-Approval Compliance Essentials for North American Market Access (US FDA + Health Canada)
Post-approval compliance in the US and Canada requires robust pharmacovigilance, quality management, regulatory lifecycle oversight, and adherence to FDA and…
