Quality Assurance Assistance

Firms that manufacture, label, package, or import health products or dietary supplements for sale in Canada and the USA must train their staff in GMP (Good Manufacturing Practices). It is a regulatory requirement. The company must meet GMP standards, SOP requirements, etc. For this crucial requirement, Quality Smart Solutions is the right name to be. We help you assure your facility is supported by qualified staff and the role of Quality Assurance. With us, you are able to learn how your company becomes compliant with Health Canada and FDA standards.

GMP Training

Supplement your FDA inspections or Site License Applications with proof of GMP training that includes training documents, training videos, opportunities to discuss GMP issues to improve functional and operational processes that result in improved productivity and cost savings.

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SOP Technical Writing

Carving a niche in Standard Operating Procedures (SOPs) Technical Writing, we write SOPs for manufacturers, labellers, packagers, importers and distributors. All SOPs written by our experienced SOP authors are specific to your organization to ensure their functions.

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Quality Assurance Designate

Avail the benefits of our Quality Assurance Designate (QAD) who will help you handle review raw material ingredients, customer complaints, change control documentation, write or update new standard operating procedures, review and sign-off on cleaning logs.

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Site Audit

We’ll periodically audit your site (facility, equipment, documents, logs, etc.) to ensure your manufacturing, labelling, packaging, importing or distribution are properly documented, and to help improve your operations and prepare you for a government audit on-site.

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Retainer

Get help from on-site personnel (temporary or permanent basis) to meet your budget needs, timeframes, and scope. Get regulatory service advice on an hourly basis or choose our pay-as-you-go bundle retainer to understand quality assurance principles, FDA or NHP regulations.

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Quality Non-Conformance Investigation

Let us be your most trusted investigator of non-compliance quality issues or qualified customer complaint handler to capture your customer’s concerns in a complaint document form, conduct a quality non-conformance investigation and report back to you.

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Adverse Reaction/Event Reporting (AER)

We have got years of experience in assisting clients or their organizations in preparing an adverse reaction report that is accurate and complete. We help you fill Adverse Reaction reporting and submit it by fax, through mail or choose to go with an online form.

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How We Serve You

We help our prestigious clients by ensuring an industry-centric approach and conducting a ‘needs analysis’ of their business goals. No matter which country you are planning to launch your business in, our highly trained and qualified officials will explain and educate, in easy to understand language, every bit of information required to legally commence your business operation. Former Health Canada inspectors and FDA officials at Quality Smart Solutions will always be accessible for your assistance and guidance.

Outcomes of Our Quality Assurance Assistance

We will serve as your formal Quality Assurance personnel or informal advisor on all matters associated with QA. So, leverage our expertise and take a Proactive and Anticipatory Approach Towards Quality and Regulatory Requirements not only to prevent revoked site license but for the health and safety of consumers.

Improve Product Quality

With Quality Assurance assistance, you can build a solid product strategy, make quality part of your company culture, and improve product quality.

High Company Standard

We consistently monitor your operations to ensure you build high standards into your company culture, meet growing customer needs.

Improve Collaboration

We utilize the latest communication tools and technologies and remain available anytime to improve collaboration and speed up productivity.

Examine & Restructure Company Processes

Holding more than a decade of expertise, we can examine and restructure your company process to ensure uninterrupted business operations.

Maintain A Better Work Culture

Build trust and hone your management skills to efficiently reinforce a better and healthy work culture.

Reduce Waste And Save Money

With regular assistance from our compliance and marketing professionals, you will be able to reduce waste and save your hard-earned money.

Why Are We the Right Fit?

Completed Projects

We have successfully completed more than 16,245 projects

Consulting Expertise

NHP, VHP, Dietary Supplements, Cosmetics, Foods, OTC Drugs, Medical Devices

Team

Former Health Canada, FDA Officials and Regulatory Industry Experts

Clients

Helped over 784 clients to cater to compliance regulations

Services Completed

128,381 services completed and counting by us successfully

Years in Service

15 years of industry experience

Live Chat

Connect with our live chat compliance expert anytime, anywhere

Multi-Language Support

We support multiple languages to serve our global customers

Frequently Asked Questions - Quality Assurance

Why is Quality Assurance important for your business?

Firms that manufacture, label, package, or import health products or dietary supplements for sale in Canada and the USA must train their staff in GMP (Good Manufacturing Practices). It is a regulatory requirement. The company must meet GMP standards, SOP requirements, etc. For this crucial requirement, Quality Smart Solutions can be your trusted partner. We help you assure your facility is supported by qualified staff and that your product is being produced safely and consistently.

What are the benefits of GMP Training?

Supplement your inspections or site license applications with proof of GMP training that includes training documents, training videos, and opportunities to discuss GMP issues to improve functional and operational processes that result in improved productivity and cost savings.

Do I need SOP Technical Writing assistance?

Carving a niche in Standard Operating Procedures (SOPs) technical writing, we write SOPs for manufacturers, labelers, packagers, importers, and distributors. All SOPs written by our experienced regulatory team are specific to your organization to ensure their functions are appropriate

What is the role of a Quality Assurance Designate?

The benefits of our Quality Assurance Designate (QAD) who will help you handle review raw material ingredients, customer complaints, change control documentation, write or update new standard operating procedures, review and sign-off on cleaning logs.

How can I ensure that my site is Health Canada and FDA compliant?

We’ll periodically audit your site (facility, equipment, documents, logs, etc.) to ensure your manufacturing, labeling, packaging, importing, or distribution are properly documented, and to help improve your operations and prepare you for a government audit on-site.