Quality Smart Solutions

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4145 North Service Road
Burlington L7L 4X6
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Company description

A One-Stop Place for All Your Health Canada and FDA Needs

Quality Smart Solutions (QSS) is a leading, niche, full-service global Regulatory Consulting Company in Canada. It supports large medium and small size firms across the globe in diverse industries in their entire Regulatory value-chain, including Regulatory Strategy, Intelligence, Dossiers, Submissions, Post- Approval / Legacy Product Maintenance, Artwork Change Management, Product Labeling, other related functions.

Within a span of 15 years, the company has served more than 784 clients and completed 128,381 services. The company has also registered over 6,000 Natural Health Products (NHPs) with a stellar success record. QSS also provides strategic support for products including NHPs, pharmaceuticals, and medical devices, in areas such as Regulatory Support, Site Licensing, Clinical Development and more.

Industries Served by QSS

Natural Health Products - (Formula Development, NPN License Registration, New Ingredient submission, Importer of Records and more)
Medical Devices (License Class Determination and Registration, Medical Device Establishment License Registration, In Vitro Diagnostic Devices Registration, Medical Device Registration, and more)
Dietary Supplements (Dietary Supplement Label Review, Supplement Facts Panel Creation, Health Claims Substantiation Dossier, New Dietary Ingredient Notification (NDIN, and more)
Cosmetic Products (Cosmetic Notification, Cosmetic Label Compliance & French Translation, Cosmetic Label Compliance)
Food & Beverage (NFT Creation, Label Compliance, HACCP and PCP Setup, and more)
Homeopathic Products (HM-DIN Package Compliance, NDC Registration, US Drug Label Compliance, and more)
Veterinary Health Products (VHP Registration, VHP Package Compliance, and more)
OTC Drugs (DIN Registration, EL Registration, NDC Registration, US Agent Service, and more)
Cannabis Solutions (CBD Product License, Federal License to Sell (Medical Purpose), Provincial License to Sell(Recreational Purposes and more.)

Solutions Provided by QSS

FOOD SAFETY (HACCP & PCP, SFCR Food License, FSMA-FSVP Program, Meat/Seafood Permit, GFSI Certification) and QUALITY ASSURANCE (SOP Technical Writing, Site Audit, GMP Training, Non-Conformance Investigation and Adverse Reaction Reporting). Global compliance solutions are provided for companies in Canada, USA, Mexico, Europe, UK, Australia and China.

Why Choose QSS

QSS helps clients by evaluating, implementing and providing all the necessary support for their products and operations so that clients can gain market access and build confidence in their brands. When you partner with QSS, you happen to get solutions from former officials of Health Canada and FDA. You will properly get assisted during the process and you will be able to comply with all rules and regulations of the concerned authorities, acts and agencies.

Solely focusing on the complete Regulatory value-chain, QSS leverages industry expertise and technology innovations to unfold next-generation, high-end regulatory compliance solutions and services that expedite performance, enhance operational excellence and allow significant cost and compliance benefits to clients.


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