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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.
Shams W.Pawel
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.
Shams W.Pawel
Amazing Grass
Global Leaders in FDA Licensing and Compliance
With a team of former FDA agency officials, regulatory experts, 510k consultants, quality assurance specialists and industry professionals we provide insights and strategies to navigate the complex journey of getting FDA approval for medical devices, 510 k Registration, and to help make clear, decisive decisions to grow your business.
15+ Years Experience
130,000+ Services Completed
Trusted By The World's Leading Organizations
Extensive Distributor Network
FDA Compliance Solutions We Offer
As one of your trusted FDA Compliance Consultant partners, we assist clients in 510 k Registration, Establishment Registration, meeting FDA labeling requirements, and getting FDA Approval for medical devices.
DIETARY SUPPLEMENT
Label Compliance
30-Day Pre Market Notification
New Dietary Ingredient Notification Filing
Facility Registration And US Agent
Food
Label Compliance And Nutrition Facts Panel Creation
Facility Registration And US Agent
Food Safety And FSMA
GRAS Self Affirmation Or Notice Filing
Medical Devices
510(K) Filing
Facility Registration And US Agent
IN-Vitro Diagnostic Test Registration
Label Review
OTC DRUG
NDC and Drug Notification
Facility Registration And US Agent
Abbreviated New Drug Application (ANDA)
Label Compliance
DISINFECTANT
EPA Registration
Label Review
Facility Registration
Claims Substantiation
COSMETICS
Claims Assessment
Label Compliance
FDA Compliance Made Easy and Faster
FDA is a federal agency of the Department of Health and Human Services in the USA, which assures safety, quality, effectiveness, and security of human and veterinary drugs, vaccines and other biological products. The agency reviews, regulates products, such as pharmaceutical drugs, veterinary drugs, medical devices, food, cosmetics, biological products and more.
If you are an organization looking for manufacturing, importing, distributing, labelling or selling medical products, health products or cosmetics in the US market, then you must be compliant with the FDA regulatory compliance. At Quality Smart Solutions, we help you by offering FDA expert compliance solutions in diverse areas, including Dietary Supplements, Foods Cosmetics, and OTC Drugs and Homeopathics (NDC). As one of your reliable FDA Consultants, we also assist you in handling FDA Registration Establishment, filling the FDA food facility registration form and getting FDA Approval for your medical devices.
“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.”
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