Quality Smart Solutions Inc.

Quality Smart Solutions Inc. Regulatory compliance and advisory for health and consumer product companies.

Navigating Health Canada, FDA, and global markets since 2007. 3,500+ companies. 74 countries. 60,000+ projects. Quality Smart Solutions is a diversified global consulting firm assisting clients worldwide primarily in the areas of regulatory compliance, quality assurance research and development, project management and business process improvement. Quality Smart Solutions has helped a diverse port

folio of clients, from start-up companies to billion dollar corporations reach their goals and help build their product portfolio. Vision:

To be a global leading advisor to consumer health product companies and be a symbol of excellence in regulatory compliance solutions. What differentiates us from the competition:

Fast turnaround time for submissions (in less than a month to submit if all conditions met), exceptional customer service and competitively priced. Our service and personal touch approach have brought about many happy clients who have had no hesitation to referred to other organizations. Services:

CANADA SOLUTIONS:
Product License Application (NPN) for Natural Health Products (NHP)
Veterinary Health Product Registration (NN)
Cosmetic Label compliance and notification submission
Food label compliance and French translation
Temporary Market Authorization Licence (TMAL) for supplemented foods
OTC Drug registration and label compliance (DIN)
Medical Device Registration (MDL) for class 2,3,4
Site License Application
Site License Renewal
Drug Establishment Licence (DEL)
Medical Device licence (MDEL)
Standard Operating Procedure writing
HACCP or P*P Food Safety Plan implementation
Importer of Record (Quality IMPORT Solutions) for NHPs
Food Importer into Canada (SFCR licensed food importer)
On-Site or remote audit
Complaint handling management
Adverse Event Reaction handling
International Regulatory Assistance (Mexico, Europe, UK, Australia)
Clinical Research support
Translation services
Artwork Design conversion solution

USA SERVICES:
Dietary Supplement Label compliance
Dietary Supplement facility registration
Food label compliance
Food facility registration
Cosmetic Label compliance
OTC Drug registration (NDC)
OTC Drug Facility Registration
510(k) medical device licence registration
Medical Device Facility registration
US Agent services
HACCP and P*P food safety plan setup
FSVP Agent service
Generally Regarded as Safe (GRAS) self attestation or FDA notice

GRAS notification or food additive petition, which pathway fits your ingredient? 🧪Swipe through for a quick breakdown of...
08/27/2026

GRAS notification or food additive petition, which pathway fits your ingredient? 🧪

Swipe through for a quick breakdown of timeline, cost, and flexibility for each. 👉

Thinking about selling cosmetics in Canada and the U.S.? 🧴 The rules aren't the same on both sides of the border.Join Ka...
08/26/2026

Thinking about selling cosmetics in Canada and the U.S.? 🧴 The rules aren't the same on both sides of the border.

Join Kati Scocchia, Senior Regulatory Specialist, for a webinar breaking down what you need to know to stay compliant in both markets.

📅 Sep 15, 2026 at 10:00 AM PT / 1:00 PM ET

👉 Save your spot: https://na3.hubs.ly/y0zZVL0

The U.S. federal government has submitted a proposed definition of "ultra-processed foods" for final review, the first t...
08/25/2026

The U.S. federal government has submitted a proposed definition of "ultra-processed foods" for final review, the first time a standardized federal UPF definition has existed in U.S. regulatory history. 🧪

No specific criteria have been disclosed and no compliance deadline has been set, but the move signals that the UPF conversation is no longer just an academic one. It is now formally entering the federal policy process.

For food manufacturers and ingredient suppliers, now is the time to begin reviewing formulations and labelling exposure rather than waiting for the final standard to land.

Our latest article covers what the announcement confirms, what it does not, and what companies should be doing in the meantime.

👉 Link in the comments.

08/25/2026

There are two pathways to establishing GRAS status for a food ingredient, FDA notification and self-affirmed GRAS, and they carry different documentation requirements.

Andrew Parshad walks through both, along with what a proper safety assessment involves. 🎥

Watch here 👇

Health Canada has updated the List of Permitted Supplemental Ingredients to allow up to 30% juice content in caffeinated...
08/22/2026

Health Canada has updated the List of Permitted Supplemental Ingredients to allow up to 30% juice content in caffeinated supplemented food beverages, up from the previous 25% threshold. 🧪

The change took effect August 13, 2026, and is permissive. Manufacturers are not required to reformulate, but those that do need to update their Supplemented Food Facts table to reflect any changes in nutrient composition. The prohibition on juice-related terms in the common name of the product remains unchanged.

Our latest article covers what changed, what stayed the same, and what manufacturers should review before considering a reformulation.

👉 Link in the comments.

The FDA has published its medical device user fee rates for fiscal year 2027, covering October 1, 2026 through September...
08/21/2026

The FDA has published its medical device user fee rates for fiscal year 2027, covering October 1, 2026 through September 30, 2027. 🩺

From premarket applications to annual establishment registration, these fees apply to any company with active or planned device programs in the U.S. market. Small businesses may qualify for significant reductions, but the application window is strict: at least 60 days before your submission is received.

Our latest article breaks down the full fee schedule and what companies should be accounting for before October 1.

👉 Link in the comments.

Thinking about selling cosmetics in Canada and the U.S.? 🧴 The rules aren't the same on both sides of the border.Join Ka...
08/20/2026

Thinking about selling cosmetics in Canada and the U.S.? 🧴 The rules aren't the same on both sides of the border.

Join Kati Scocchia, Senior Regulatory Specialist, for a webinar breaking down what you need to know to stay compliant in both markets.

📅 Sep 15, 2026 at 1:00 PM ET

👉 Save your spot: https://na3.hubs.ly/y0zZYm0

An MDEL cancellation halts your ability to import or distribute devices in Canada. 🚫Swipe through for the 5 most common ...
08/19/2026

An MDEL cancellation halts your ability to import or distribute devices in Canada. 🚫

Swipe through for the 5 most common reasons Health Canada cancels a licence and what keeps yours in good standing. 👉

08/17/2026

Sports electrolyte products in Canada are moving from the NHP framework to the food regulatory framework, and the details matter. 🎙️

In our latest webinar, QSS's Regulatory Solutions Specialist Nickan Sadghian walked through the classification shift, including the ORS exception for dehydration products and the December 31, 2027 target date for existing NPN holders to transition.

The bottom line: electrolyte content alone doesn't decide classification. Category, formula and conditions all play a role. 💡

Watch the full webinar here 👉 https://na3.hubs.ly/y0zKbx0

Health Canada is consulting on proposed changes to the List of Recognized Standards for medical devices, and feedback is...
08/15/2026

Health Canada is consulting on proposed changes to the List of Recognized Standards for medical devices, and feedback is open until September 25, 2026. 🩺

If your regulatory team has active device licence applications or technical files that reference standards on this list, now is the time to review the draft and flag anything relevant before the consultation closes.

Health Canada is also introducing a continuous year-round feedback process going forward, so this type of input will no longer be limited to periodic consultation windows.

👉 Read the full article: https://na3.hubs.ly/y0zJw-0

Address

4145 North Service Road Suite 200
Burlington, ON
L7L6A3

Telephone

+18003965144

Website

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