Dell Tech is a Canadian regulatory affairs consulting firm that helps businesses launch and maintain compliant products in Canada’s highly regulated market. We have supported clients across a range of industries for more than four decades, providing guidance in product classification, formula review, labeling, registration, licensing, and submission strategy.
We support Canadian regulatory submissions and compliance for a broad range of product categories, including:
From classification and formula assessment to labeling review and Health Canada submission, we work with manufacturers, importers, distributors, and private label companies to ensure their products are approved and compliant.
Our team has spent over 40 years helping businesses meet Canadian regulatory requirements across pharmaceuticals, personal care products, food, and chemicals.
We bring together regulatory consultants, chemists, and industry specialists to deliver tailored guidance based on your product and business model.
From early-stage product classification and formula review to licensing, submission, and labeling compliance, we manage the full regulatory process for you.
Dell Tech serves clients around the world, helping international companies gain access to the Canadian market with clarity and confidence.
Cosmetics do not require pre-market approval in Canada, but you must file a Cosmetic Notification Form with Health Canada within 10 days of first sale. Your label, claims, and ingredients must still meet all safety and marketing regulations.
Natural Health Products include vitamins, minerals, and plant-based remedies, while OTC drugs include pharmaceuticals with active ingredients. The regulatory pathways differ in terms of licensing, testing, and compliance requirements.
A Drug Identification Number is required for therapeutic drugs, including disinfectants and OTC medications. It is issued by Health Canada once the product’s safety, efficacy, and quality have been reviewed and approved.
We evaluate your product’s chemical composition, determine the CEPA status of all the ingredients in your formulation (DSL, NDSL, New, Schedule 1, sNAC etc) and if notification is required, and prepare the full CEPA New Substance Notification submission package. We help avoid delays and ensure proper reporting.
PMRA approval involves data evaluation, e-indexed submission preparation, and ongoing communication with regulators. Dell Tech supports the full pesticide registration cycle, including product classification and portal navigation.
Importing veterinary drugs or health products requires classification under VDD, notification or registration, and compliant labeling. Dell Tech guides clients through every regulatory step required for Canadian distribution.
Receive updates on Health Canada requirements, ingredient disclosure expectations, regulatory reform, and emerging compliance trends.
