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Leaders in Natural Health Product Compliance Solutions since 2007
Quality Smart Solutions has registered over 5,000 Natural Health Products (NHPs) serving over 700 clients since 2007 with a stellar success record. We have emerged as a global leader NHP consulting firm in Health Canada registrations.
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Medical Device Licensing Experts for Canada & USA
Quality Smart Solutions offers one-stop medical device licensing solutions such as Class I, II, III, IV medical device registration, medical device establishment license and renewals.
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Proven Expertise

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Services Completed

NHP

  • NPN License
  • Label Compliance
  • Site License
  • Importer of Record

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Food

  • Label Compliance
  • TMAL Registration
  • SFCR Food License
  • PCP and HACCP Food Safety

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Medical Devices

  • Medical Device Registration
  • IVD Registration
  • MDEL Registration
  • MDL Label Compliance

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OTC Drug

  • DIN Registration
  • Disinfectant Licensing
  • Label Compliance 
  • DEL Registration

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Cosmetics

  • Cosmetic Notification
  • Label Compliance Review
  • Hot List Check

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Veterinary Health Products

  • VHP Notification Number
  • PSL Submission
  • Label Compliance
  • Canadian Representative

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Dietary Supplement

  • Label Compliance
  • 30-Day Pre Market Notification
  • New Dietary Ingredient Notification Filing
  • Facility Registration And US Agent

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Food

  • Label Compliance And Nutrition Facts Panel Creation
  • Facility Registration And US Agent
  • Food Safety And FSMA
  • GRAS Self Affirmation Or Notice Filing

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Medical Devices

  • 510(K) Filing
  • Facility Registration And US Agent
  • IN-Vitro Diagnostic Test Registration
  • Label Review

See All

OTC Drug

  • NDC and Drug Notification
  • Facility Registration And US Agent
  • Abbreviated New Drug Application (ANDA)
  • Label Compliance

See All

Disinfectant

  • EPA Registration
  • Label Review
  • Facility Registration
  • Claims Substantiation

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Cosmetics

  • Claims Assessment
  • Label Compliance

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Why Quality Smart Solutions?

We take a personal approach to every client’s needs and goals. Our mission is to see your business thrive through compliance and risk mitigation. With a team consisting of former regulatory agency officials from Health Canada and from FDA we  provide insights and strategies to navigate the complex journey of regulations to help you make clear, decisive decisions to grow your business.

Fast and Timely Compliance Solutions

You can’t afford to be reactive with more significant non-compliance penalties. We offer proactive compliance solutions and keep you updated with real-time compliance intel.

Global Growth through Compliance

We support your domestic and international growth by offering relevant regulatory solutions for your business so you comply with the applicable jurisdiction's regulations.

Safeguard Your Business

We safeguard your business by identifying risk of breaching compliance. Our professionals determine which compliance regulations apply to your industry and implement them successfully.

On-Demand Priority Compliance

Input your key data and let our experts examine them. Leverage our expertise to proactively manage your global compliances with our former regulatory agency officials. We also remind you of deadlines.

Testimonials

Edward Ro Amazing Grass

“We’ve worked with Andrew and the QSS team for 5 years and they’ve always been very knowledgeable and professional. They’re a tremendous partner to have when dealing with Health Canada compliance regulations and will always work with you to come up with the best solutions.”

Michael T MT Consulting

I have been working with Andrew and his team at QSS for a couple of years now. I have clients from many different parts of the world and each situation requires expertise and focus, which I’m getting from QSS. I highly recommend Andrew and QSS to any perspective client who wants to “get it right” regarding Canadian and cross border compliance.

Don Gauvreau Pharma Freak

I've used QSS services for many years now and they always deliver a very professional service. Everyone on the team is great to work with and the always come up with great solutions for your needs at a great price!

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Follow Latest News, Blogs & Industry Updates
Ensuring Predictability for Interim Orders Relating to COVID-19
December 15, 2020
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Ensuring Predictability for Interim Orders Relating to COVID-19

Health Canada recently published an additional notice regarding all interim orders relating to COVID-19...
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Additional Packaging and Labelling Requirements for Alcohol Based Hand Sanitizers in Beverage Containers
October 9, 2020
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Additional Packaging and Labelling Requirements for Alcohol Based Hand Sanitizers in Beverage Containers

On October 5, 2020, the Natural and Non-Prescription Health Products Directorate (NNHPD) sent a...
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FDA Announces FSMA Food Traceability Proposed Rule
September 25, 2020
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FDA Announces FSMA Food Traceability Proposed Rule

On Monday September 21st, the U.S. Food and Drug Administration (FDA) announced a proposed...
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Regulatory Considerations for Non-Medical Masks or Face Coverings
September 13, 2020
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Regulatory Considerations for Non-Medical Masks or Face Coverings

Earlier this summer, Health Canada provided a notice to industry on the regulatory considerations...
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Interim Order Respecting Clinical Trials Relating to COVID-19
June 6, 2020
| |

Interim Order Respecting Clinical Trials Relating to COVID-19

On May 23, 2020, the Minister of Health of Canada approved an Interim Order...
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Clarifications and requirements regarding the interim measure for Hard Surface Disinfectants and Hand Sanitizers
May 29, 2020
| |

Clarifications and requirements regarding the interim measure for Hard Surface Disinfectants and Hand Sanitizers

In light of the current COVID-19 pandemic, Health Canada is taking action to increase...
Read More
What is HACCP and Food Handler’s Certification
April 26, 2020
| |

What is HACCP and Food Handler’s Certification

What is HACCP Plan Food safety is always evolving and becoming more complex, as...
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How to Develop a HACCP Plan
April 21, 2020
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How to Develop a HACCP Plan

The purpose of a Hazard Analysis Critical Control Points (HACCP) plan is to identify...
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Health Canada expedites access to COVID-19 diagnostic laboratory test kits and other medical devices
April 15, 2020
| |

Health Canada expedites access to COVID-19 diagnostic laboratory test kits and other medical devices

Recently in Canada, the Minister of Health has signed an Interim Order to allow...
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COVID-19 FIGHT: Hand sanitizers and disinfectants compliance – Canada and US
March 23, 2020
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COVID-19 FIGHT: Hand sanitizers and disinfectants compliance – Canada and US

In light of the recent Coronavirus pandemic, the demand for antimicrobial products such as disinfectants...
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Q&A: Selling Hand Sanitizers in Canada during COVID-19 pandemic
March 22, 2020
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Q&A: Selling Hand Sanitizers in Canada during COVID-19 pandemic

With the need for hand sanitizers significantly increasing for healthcare personnel and individuals during...
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Protecting Canadians from Unsafe Drugs Act
February 3, 2020
| |

Protecting Canadians from Unsafe Drugs Act

The Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) introduces amendments to the Food and Drugs Act that...
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