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GUIDING YOU THROUGH GLOBAL REGULATIONS

Navigate compliance with clarity and confidence.

Regulatory compliance doesn’t need to slow you down. We walk you through exactly what’s needed to get approved and stay compliant in Canada, the U.S., and beyond.

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Helping businesses meet global compliance, one step at a time.

With thousands of submissions behind us, we know what regulators look for. We use that experience to guide you through the process with clarity and confidence.
3,500+
clients
4.8/5
customer rating
74
countries
18+
years in compliance

Solutions for every industry

We give your business the knowledge and support to choose the right path, prepare strong submissions, and meet global standards.

Food and Beverage
In Canada, we support front-of-package labelling, Nutrition Facts Table creation, French translation, supplemented and novel food submissions, and SFCR licensing. For U.S. compliance, we help with facility registration, food label reviews, and FCE registration.
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Ingredients
We help you meet regulatory requirements for ingredients in Canada, the U.S., Europe, Australia, and other global markets. Our support includes GRAS self-affirmation, GRAS notifications, novel food applications, safety assessments, and ingredient classification.
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Cosmetics
In Canada, we help with cosmetic notifications, label compliance, French translation, and Canadian Cosmetic Agent services. In the U.S., we support MoCRA product listing, facility registration, manufacturer inspections, and safety substantiation.
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OTC Drugs
Our team supports Canadian drug compliance through DIN registration, NDS and ANDS submissions, and DEL applications. For U.S. compliance, we help with Drug Establishment Registration and Renewal, Drug Listing (DRLS), and National Drug Code (NDC) registration.
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Medical Devices
We support Canadian requirements including MDL, MDEL, and SaMD registration. For U.S. compliance, we guide you through 510(k) submissions, facility registration, FURLS listing, IVD and SaMD registration, and PMA pathways.
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Dietary Supplements & NHPs
We help with NHP licensing, site licences, and homeopathic submissions in Canada, along with dietary supplement compliance in the U.S., including facility registration, NDINs, label reviews, and Supplement Facts Panels.
Veterinary Health Products
We help you register VHPs with Health Canada, meet label and packaging requirements in both English and French, and act as your Canadian representative for regulatory purposes.
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Other Products
We support cannabis licences, homeopathic medicines, and facility audit readiness, helping you prepare the right documentation and meet evolving compliance requirements.

Compliance across regions

We help businesses navigate regulatory systems in Canada, the U.S., and other key global markets.

Canada

Licensing and compliance for NHPs, foods, cosmetics, OTC drugs, ingredients, medical devices, and VHPs

United States

Support for dietary supplements, food, cosmetics, OTC drugs, ingredients, and medical device registration

European Union (EFSA)

Novel food, food additive, and traditional food applications for EU market entry

Australia (TGA & FSANZ)

Regulatory support for new substances and product submissions

United Kingdom (MHRA & FSA)

Novel food submissions and product compliance for the UK

New Zealand (FSANZ)

Guidance for FSANZ novel food applications and compliance requirements

China (CFDA)

Entry support and regulatory guidance for CFDA-compliant products

Mexico

Support for labelling and regulatory pathways for products sold in Mexico

Trusted by leading companies

What our clients say

We help businesses navigate regulatory systems in Canada, the U.S., and other key global markets.

“I have been working with Quality Smart Solutions since starting my brand and I am extremely impressed with their attention to detail, knowledge, and fast turnaround time. I look forward to working with them for many years to come.”

Aeryon Wellness

“Their team was professional, knowledgeable, and efficient, making the process smooth and stress-free. Highly recommend their services!”

Real House Team

“If you need an amazing, reliable agency, you need to deal with them. Great consultants and amazing customer service.”

Michael Zakini
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How we help you succeed

Proven expertise

Our team includes toxicologists, scientists, and former regulatory agency experts who understand the process inside and out.

Guidance from start to finish

We help you make informed decisions at every stage, from assessment to submission.

Efficient, reliable support

We take a practical, hands-on approach to help you stay organized, avoid delays, and meet your deadlines with confidence.

Latest news & events

We work closely with businesses of all sizes to guide them through complex regulatory processes. Here’s what some of them have shared.
Cargo shipments facing new compliance requirements after the end of the de minimis rule

De Minimis Rule Ending: What Businesses Must Know

The de minimis rule is ending in the U.S. Learn what this means for compliance, shipping costs, and your regulatory strategy.
GMP training session with professionals reviewing compliance requirements

What You Need to Know About GMP Training

Learn what GMP training is, why it matters, and who needs it. Explore GMP fundamentals and compliance requirements for Health Canada and
FDA PreCheck program to strengthen U.S. drug manufacturing supply chain

What the New FDA PreCheck Program Means for Drug Manufacturers

FDA PreCheck program aims to boost U.S. drug manufacturing. Learn how it could impact domestic pharmaceutical facilities and compliance steps.

Need help navigating compliance? Let’s connect.

We’ll guide you through the process, explain what’s required, and help you move forward with confidence.
Schedule a call
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