Quality Smart Solutions Inc.

Name: Quality Smart Solutions Inc.
Address: 4145 North Service Road Suite 200, Burlington, ON, L7L6A3, CA
Telephone: +18003965144

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Burlington, ON
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

06/04/2026

One week until our GRAS vs NDI webinar. 📅

If you haven't registered yet, now's the time. On June 9 at 1:00 PM ET, QSS Senior Regulatory Specialist Bryana Hallam walks through both U.S. ingredient pathways, what they require, how they compare, and how to choose the right one for your product. 🔬

Reserve your spot before June 9: https://na3.hubs.ly/y0sjYt0 🎯

06/02/2026

Wondering what's actually happening with Self-Affirmed GRAS? Andrew Parshad, CEO of Quality Smart Solutions, recorded this from Barcelona after a week of conversations at Vitafoods. 🧪

The short version: a final enforcement date could be as far out as 2030 or 2031, but the GRAS notification backlog is already growing. Companies that wait risk not having their submissions reviewed in time, or missing an enforcement deadline before their dossier is even filed.

Andrew's advice: start your GRAS dossier now, and build a strategy that accounts for the timeline ahead.

05/31/2026

The FDA finalized its food chemical safety assessment program on May 12, 2026, marking a significant shift in how the agency oversees chemicals already in the U.S. food supply. 🧪

BHT (butylated hydroxytoluene) and ADA (azodicarbonamide) are the first two substances formally under review. Both Requests for Information are open until July 13, 2026, and the FDA is actively encouraging food manufacturers and researchers to submit relevant data before the deadline.

What food and ingredient companies should know:

- The framework covers food additives, colour additives, GRAS substances, food contact substances, and contaminants. No category is automatically exempt.
- The FDA will use a Prioritization Tool to determine which chemicals enter the review pipeline next, based on toxicity, exposure changes, and new scientific information.
- Companies should ensure their ingredient safety substantiation is current and documented across their full portfolio, not only for ingredients currently flagged. 📋

👉 Read the full article: https://na3.hubs.ly/y0v1q60

05/30/2026

The FDA published updated OMUFA arrears and paid facilities lists on May 11, 2026, and the FY 2026 fee deadline is June 1, 2026. 💊

OMUFA (Over-the-Counter Monograph Drug User Fee Program) applies to facilities that manufacture or process finished dosage forms of OTC monograph drugs. If your facility hasn't paid its annual fee, here's what you need to know:

- FY 2026 rates: $19,188 for Monograph Drug Facilities and $12,792 for CMOs.
- Non-payment within 20 days of the deadline triggers a public arrears listing and misbranding of all affected OTC products.
- Brand owners using contract manufacturers should also confirm their CMO's status — a non-compliant CMO can affect your products even if your own fees are current. 📋

Foreign facilities are subject to the same requirements as domestic manufacturers.

👉 Read the full article: https://na3.hubs.ly/y0v1mS0

05/29/2026

The FDA has announced its intent to exempt certain Class II clinical toxicology test system devices from 510(k) premarket notification requirements. 🩺

Published in the Federal Register on May 1, 2026, the notice opens a 60-day public comment period closing June 30, 2026. If finalized, affected device types would no longer require a 510(k) submission before market, though quality system requirements and special controls would still apply.

Worth noting:

- Prior exemption orders have included limitations based on intended use, meaning not all products within a device category are automatically covered.
- The FDA must issue a final order within 120 days of the notice. 📋

👉 Read the full article: https://na3.hubs.ly/y0v0YS0

05/28/2026

The GRAS vs NDI decision isn't just a regulatory formality. Choosing the wrong pathway can mean FDA action, legal exposure, or going back to square one. 📋

Getting it right from the start protects your product, your timeline, and your U.S. market entry strategy. 🎯

On June 9 at 1:00 PM ET, QSS Senior Regulatory Specialist Bryana Hallam breaks down both pathways and how to determine the right fit for your ingredient before you commit. 🔬

Reserve your spot: https://na3.hubs.ly/y0sk030 🌎

05/27/2026

Our team was in Ottawa this week for the CHFA Ottawa Regulatory Forum, and the conversations were worth the trip. 🍁

From red tape reduction to NHP labelling, cost recovery, and regulatory modernization, a lot is shifting right now. Hearing directly from NNHPD and Health Canada on where things are headed makes a real difference in how we guide our clients.

The NHP landscape doesn't sit still, and neither do we. 🌿

05/26/2026

We're live at the CHFA Regulatory Forum in Ottawa. 🌿

QSS is walking the floor at The Westin Ottawa today and tomorrow, connecting with industry leaders, Health Canada executives, and policymakers driving the future of Natural, Organic, and Wellness in Canada. 📋 If you're here, let's find time to talk. 🤝

👉 Book a meeting: https://na3.hubs.ly/y0rRrb0

05/25/2026

Did you know the FDA doesn't approve your supplement label before it goes to market? That's on you as the brand owner, and the rules are more detailed than most companies expect. 📋

In this video, Andrew Parshad of Quality Smart Solutions walks through what a compliant U.S. dietary supplement label actually requires, including the Supplement Facts panel, ingredient and allergen declarations, structure-function claims, and the steps brands most commonly miss.

Watch the full video here: https://na3.hubs.ly/y0tJSv0

Have questions about your label? Reach out to our team at https://na3.hubs.ly/y0tJRC0 💬

05/21/2026

GRAS or NDI? Here's the short version. 🔬

GRAS applies when an ingredient's safety is backed by scientific consensus or a long history of use. NDI notification is required for dietary ingredients that weren't marketed in the U.S. before October 15, 1994.

Choosing the right pathway comes down to your ingredient, its history, and its intended use in your product. 🎯

We're breaking it all down on June 9 at 1:00 PM ET. Join us. 🌎

Reserve your spot: https://na3.hubs.ly/y0sjYl0 📋

Address

4145 North Service Road Suite 200
Burlington, ON
L7L6A3

Telephone

+18003965144

Website

http://www.qualitysmartsolutions.com/

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