What Quality Smart Solutions does

Quality Smart Solutions is a Burlington, Ontario-based regulatory compliance consulting firm founded in 2007 that guides health-product, food, cosmetics, medical-device, OTC-drug, veterinary, and cannabis companies through Canadian, U.S., and international regulatory pathways. Its core offering is professional advisory services rather than a software platform, delivered by a team that includes toxicologists, scientists, and former regulatory agency officials, with specialized bilingual French-translation capability for Canadian labeling. Service lines span NPN applications, NHP labeling and master files, Food Compliance (FOP labeling, NFT creation, SFCR licensing, novel food notifications), medical device registration (MDL/MDEL/SaMD), cosmetic notifications, OTC drug DIN/NDS submissions, cannabis licensing, USA FDA compliance (510(k), MoCRA, NDIN, FSVP), and international filings across the EU, UK, Australia/NZ, China, and Mexico. The firm is also a registered third-party International Trade Certificate issuer and an Amazon Service Provider Network partner for Amazon Canada marketplace compliance.

The business operates on a project-based and engagement-based professional services model with custom quote-based pricing; the company does not publish pricing or disclose revenue. Customer reach includes 3,500+ clients, 60,000+ completed projects, and 9,000+ NPNs approved across 74 global markets since inception, with notable enterprise accounts including Unilever, Nestlé, Bausch, Jamieson, Biosteel, BANG Energy, Vital Proteins, Optimum Nutrition, and Hydralyte. Distribution is direct consultative sales, supported by content marketing (blog, webinars, YouTube, LinkedIn, newsletter, client testimonials). The firm is privately held and bootstrapped, with no disclosed equity funding, parent company, subsidiaries, or acquisition activity, and operates with 11-50 employees from its Burlington headquarters.

Name

Quality Smart Solutions

Legal name

Quality Smart Solutions

Website

https://qualitysmartsolutions.com

Company type

Private

Founded year

2007

Operating status

Operating

Headcount range

11–50 employees

Short description

Quality Smart Solutions is a Burlington, Ontario regulatory compliance consulting firm founded in 2007 that guides health-product, food, cosmetic, medical-device, and cannabis companies through Canadian, U.S., and international regulatory pathways via project-based advisory services.

Ownership category

akta.pro rank

Product category

Regulatory Compliance Consulting

NAICS

Testing Laboratories and Services (541380)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Regulatory Affairs, Labeling & Advertising/Promotion Compliance (HLAJADAI)

akta.pro secondary industries

Regulatory Consulting & Compliance Program Management (FDA/USDA/EFSA) (AFALADAC), Third-Party/Outsourced Quality & Responsible Person Services (EU QP/RP, US Agent) (HLAGAKAO)

Keywords

• Regulatory compliance consulting
• Natural health product licensing
• FDA dietary supplement compliance
• Food safety audits
• Bilingual label translation

Headquarters

HQ city

Burlington

HQ country

Canada

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Technology or R&D

Revenue model

1. Regulatory Consulting Services: Professional consulting services for regulatory compliance including NPN applications, site licensing, label reviews, food safety audits, and compliance assessments across Health Canada, FDA, and international markets. Services are typically project-based or engagement-based.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels6 records

Core offering

Quality Smart Solutions is a regulatory compliance consulting firm that advises manufacturers and brands on navigating Health Canada, FDA, and international regulatory frameworks for natural health products, foods, cosmetics, medical devices, OTC drugs, veterinary health products, and cannabis. The firm provides end-to-end services spanning product classification, application preparation and submission (NPN, DIN, MDL, MDEL, SFCR), bilingual English/French label review and translation, audit preparation, and post-licensing support. It also operates as a registered third-party International Trade Certificate issuer for NHPs and GMP compliance, and serves as an Amazon Service Provider Network partner for marketplace compliance.

Product overview

Quality Smart Solutions is a regulatory compliance consulting firm that offers a comprehensive suite of advisory services rather than a software product platform. The company's offerings center on regulatory guidance across multiple jurisdictions (Canada, USA, and international markets) for industries including Natural Health Products, foods, cosmetics, medical devices, OTC drugs, veterinary products, and cannabis. Key service modules include NHP Licensing Services (covering NPN applications, label compliance, French translation, homeopathic DINs, master files, site licensing, and formula development), Food Compliance Services (including FOP labeling, nutrition facts tables, supplemented foods, novel food submissions, SFCR licensing, and food safety audits), Medical Device Compliance, Cosmetic Compliance, OTC Drug & Controlled Substances services, VHP Licensing, Cannabis Compliance, USA FDA Compliance Services, Global Regulatory Solutions (EU, UK, Australia, China, Mexico), Import Solutions, Food Safety & Quality Assurance, Clinical Trials & Research, and Amazon Seller Compliance support. The company operates as an Amazon SPN partner and registered third-party International Trade Certificate issuer. With over 19 years of experience since 2007, they have guided 3,500+ clients and completed 60,000+ projects across 74 global markets.

Differentiator

Problem solved

Functional benefit

Products and services

• NHP Licensing Services Natural Health Product licensing services for manufacturers and brands of vitamins, minerals, probiotics, supplements, and traditional medicine products seeking to enter or expand in the Canadian market through Health Canada regulatory pathways.
• Food Compliance Services Food regulatory compliance services for food manufacturers, importers, and exporters requiring Canadian and U.S. food safety compliance, including labeling, nutrition, and SFCR licensing.
• Medical Device Compliance Canadian medical device regulatory services for medical device manufacturers requiring Health Canada MDL/MDEL approvals and SaMD registration.
• Cosmetic Compliance Services Canadian cosmetic regulatory services for cosmetic product manufacturers requiring Health Canada notifications, bilingual labeling, and agent representation.
• OTC Drugs & Controlled Substances Over-the-counter drug compliance services for OTC drug manufacturers requiring Health Canada DIN, NDS/ANDS submissions, and Drug Establishment Licensing, including psychedelics regulatory support.
• Veterinary Health Products (VHP) Licensing Veterinary health product licensing services in Canada covering VHP registration, bilingual packaging translation, and importer of record services.
• Cannabis Compliance Services Canadian cannabis regulatory services for cannabis producers and retailers requiring federal Health Canada licensing, provincial retail authorization, and ongoing post-licensing support.
• USA FDA Compliance Services Comprehensive U.S. FDA regulatory compliance services across dietary supplements, drugs, food, cosmetics, medical devices, and human/animal ingredients, including U.S. Agent and FSVP Agent representation.
• Global Regulatory Solutions International regulatory compliance services covering the EU, UK, Australia, New Zealand, China, and Mexico for novel food applications, traditional food applications, food additive submissions, and country-specific regulatory pathways.
• Import Solutions Import compliance services for medical devices, natural health products, and food products requiring Importer of Record representation and U.S. FSVP Agent services at borders.
• Food Safety & Quality Assurance Food safety and quality assurance consulting including HACCP plans, SFCR licensing, GFSI certification, GMP training, SOP writing, site audits, non-conformance investigation, and adverse reaction reporting.
• Clinical Trials & Research Services Clinical research support services including study design, preclinical research, clinical trial execution, data management, and scientific writing for health claims publications.
• Amazon Seller Compliance Amazon SPN partner compliance services for brands selling on Amazon.ca, helping meet marketplace requirements and resolve delisting and compliance notice issues.

Quantifiable outcome

• 3,500+ clients guided to market
• +4 more outcomes

Named customers17 records

Segments7 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

One partnership is on record.

• Amazon Service Provider Network (SPN)minorChannel Partner/ Reseller/ DistributorQuality Smart Solutions is an Amazon Service Provider Network partner, providing compliance services to help brands meet Amazon marketplace requirements and resolve compliance challenges when selling on Amazon.ca. Benefits include faster issue resolution for delisting and compliance notices.

Scale indicators6 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Registrar Corp: Registrar Corp is a U.S.-based regulatory compliance firm providing FDA US Agent services, food/drug/cosmetic/medical device registration, and labeling compliance — directly overlapping with QSS's U.S. Agent, dietary supplement, and medical device service lines.
• Emergo by UL Solutions: Emergo by UL is a regulatory consultancy specializing in medical device and IVD compliance across global markets (FDA 510(k), Health Canada MDL, EU MDR). It is a direct peer to QSS in the medical device regulatory vertical.
• mdi Consultants: mdi Consultants is a regulatory affairs and quality assurance consulting firm serving FDA and Health Canada submissions for drugs, devices, and combination products — closely comparable to QSS in North American life-sciences regulatory work.
• RQM+: RQM+ is a regulatory and quality consulting firm focused on medical devices, IVDs, and combination products, offering services comparable to QSS's Health Canada MDL/MDEL/SaMD and FDA 510(k) work, but with a deeper medical device specialization.

Broad incumbents

• NSF International: NSF is a large public health and safety organization providing testing, certification, and regulatory consulting across food, supplements, cosmetics, and water. It overlaps with QSS's food safety audit, HACCP, and supplement compliance services, but at much larger scale and broader scope.
• SGS: SGS is one of the world's largest testing, inspection, and certification firms with extensive food, life sciences, and consumer goods regulatory capabilities. It competes with QSS for global regulatory work but operates at vastly greater scale across dozens of verticals.
• Intertek: Intertek is a global TIC firm offering testing, certification, and regulatory advisory across food, pharma, and consumer products. Comparable to QSS in food safety, labeling, and global market entry services but with much broader industry and geographic footprint.
• Bureau Veritas: Bureau Veritas is a global TIC incumbent providing testing, inspection, and certification including food, agri-commodity, and consumer goods regulatory services. It is a broad competitor in food safety audits and quality assurance where QSS also operates.

Emerging players

• REACH24H: REACH24H is a China-based regulatory consultancy covering global chemical, food, cosmetic, and consumer product compliance. It overlaps with QSS's Global Regulatory Solutions line (EU, China, Australia) and serves as a comparable cross-border regulatory advisory.
• Kestrel Management Services: Kestrel Management Services is a regulatory affairs consultancy providing Health Canada and FDA submission support for NHPs, OTC drugs, cosmetics, and medical devices — directly comparable to QSS in Canadian NHP licensing and label compliance services.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/qualitysmart
• YouTubeyoutube.com/user/QualitySmartSolution
• Facebookfacebook.com/QualitySmartSolutions
• LinkedInlinkedin.com/company/quality-smart-solutions-inc.
• Instagraminstagram.com/qualitysmartsolutions

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Quality Smart Solutions