Are you searching for a Regulatory Compliance Consultant that can help you acquire a Natural Product Number (NPN) for your NHP product? If so, Quality Smart Solutions is the right place. QSS is a renowned global consulting firm with a successful track record of registering more than 5,000 NPNs since inception. This company helps meet compliant bilingual label requirements and an Importer of Recorder. Get assistance in preparing a Product license application (PLA), Electronic Product License Application (ePLA) for a class 1 or 2 NHP, Electronic Product License Application for a class 3 NHP, an Evidence Summary Report (it includes information for safety and efficacy support) and a finished product specification form. For more information about Regulatory Compliance Service at Quality Smart Solutions, visit the official website https://qualitysmartsolutions.com/.

1. WHO IS QUALITY SMART SOLUTIONS?
We are a science and compliance consulting firm
globally serving consumer health product companies.
Our areas of expertise are Dietary Supplements (Natural
Health Products), Foods, Cosmetics and Drugs.
QUALITY SMART SOLUTIONS is headquartered in
Burlington, Ontario, Canada and was founded in 2006. President and Founder,
Andrew Parshad has been actively involved in the Health Products industry since
1997, has been an integral member in government stakeholder meetings, and has
co-authored several publications on natural health products.
WHY CHOOSE US?
Simple. QUALITY SMART SOLUTIONS offers a superior level of
knowledge, care and commitment to our clients. We provide value
unparalleled in this industry!
Our client-focused, creative, and solutions-oriented approach to
science and compliance challenges has helped us to grow and
retain a large clientele for many years.
Our clients will tell you we are Fast, Cost Effective and High
Quality. Our process-based approach to projects keeps
our clients satisfied with every engagement. Many of our
clients have informed us they look forward to continuing our
partnership and have also highly recommended our services to
others in the industry. That speaks volumes to the caliber of
work and level of engagement we keep.
Our Clients Come FIRST. Our Results Come FAST.
Personal Touch, Client-Centric Service.
Smart, Process Driven Approach & Solutions
= FAST and Done Right the FIRST TIME!
Creative solutions for Your regulatory, quality
and business needs.
Well connected with a huge network in the
Health Products Industry.
THE QUALITY SMART DIFFERENCE:
Still not
enough
reasons?
Here are
10 more!

2. SOLUTIONS FOR YOU
Regulatory Compliance (Canada)
• Canada Natural Health Product
License (NPN)
• New Ingredient Submission
(NHPID)
• NHP Master File Submission
(NHP-MF)
• Site License
• Low Risk Veterinary Health
Products (LRVHP)
• Temporary Market Authorization
License (TMAL)
• Interim Market Authorization (IMA)
• Novel Food Additive Application
• Food Regulatory Assistance
• Cosmetic Notification
• OTC Drug Identification Number
License (DIN)
• Health Canada Pre-Submission
Meeting
• French Translation
Regulatory Compliance (USA)
• Dietary Supplements
• Generally Regarded as Safe
(GRAS) Notification
• US Compliant Label Creation &/
or Review
• Food Additive Petition
• Cosmetic Product Ingredient
Statements (CPIS) submission
Regulatory Compliance (International)
• European Union (EFSA)
• United Kingdom (MHRA)
• Latin America
• Other Countries (check with us)
Quality Assurance
• GMP Training
• Technical Procedures Writing
• Quality Assurance Designate
• Change Control
• Site Inspection
• Customer Complaint Handling
• Adverse Reaction Handling &
Reporting|
• Importer on Record
Analytical Solutions
• Identity Testing
• Contaminant Screening
• Stability Studies
• Material Characterization
Research Solutions
• Clinical Trials for NHPs
• Product Development
• Formula & Advertisement
Review
• Health Claim Substantiation
• Method Development/
Implementation
• Method Validation
• Target Compound Isolation
• Synthetic Chemistry
• Process Development
• Fermentation
1.800.396.5144
www.qualitysmartsolutions.com
info@qualitysmartsolutions.com
Solutions for you

3. CANADIAN IMPORT SOLUTIONS
Founded on quality, QUALITY IMPORT SOLUTIONS
can assist you with importation of health products,
storage, and third party logistics.
IMPORTATION
We are a Canadian licensed importer of natural health products (NHP). We can bring licensed NHPs into
Canada from anywhere in the world.
Using Quality Import Solutions is a simple and cost-effective alternative to setting up your own
Canadian-based import site.
The typical Canadian import model for NHPs:
We handle product release; we coordinate and report on the annual reduced testing program and we handle
complaint and/or adverse reaction reporting.
Our affiliate distribution center is GMP compliant and provides storage, fulfillment and logistics solutions.
OUR SOLUTION:
Foreign (ie: Outside
Canada) Manufacturer
Food, Drug, Mass Supply Chain
Independent Channel Supply Chain
Foreign (ie: Outside
Canada) Manufacturer
Importer (Quality Import
Solutions)
Importer (Quality Import
Solutions)
Warehouse
(annexed to QIS)
Warehouse
(annexed to QIS)
Warehouse from which
FDM retailers draw from
FDM Retailer
Independent
Retailer

4. 1.800.396.5144
www.qualitysmartsolutions.com
info@qualitysmartsolutions.com
Dietary Supplements
• Product Review and Release
•
Complaint and Adverse Reaction handling and investigation
• Storage and Logistics solutions
• Change Control
CANADIAN IMPORT
SOLUTIONS
Your Canadian
Import Solutions
Manufacturing site must be annexed
to Quality Import Solutions (and must
attest to GMP compliance).
Manufacturing records and product
testing must be maintained, and may
be requested from time to time by
Quality Import Solutions.
FOREIGN (NON-CANADIAN)
COMPANY REQUIREMENTS
TO EXPORT THROUGH
QUALITY IMPORT SOLUTIONS:

5. USA REGULATORY SOLUTIONS
QUALITY SMART SOLUTIONS is your ideal
partner for American Regulatory Compliance.
DIETARY SUPPLEMENTS
Dietary Supplements are regulated under a set of regulations
separate from food and drugs. The Dietary Supplement Health and Education Act of 1994 (DSHEA).
FDA regulates both finished dietary supplement products and dietary ingredients under these
regulations. FDA approval is not granted for
Dietary Supplements. Instead, manufacturers
are responsible for ensuring their products are
safe prior to marketing. FDA will take action
against an unsafe product after it reaches the
market. Companies making structure/function
claims are responsible for keeping scientific
substantiation on file in the event FDA makes
a request to review documentation for your
label claims. Additionally, a notification must
be submitted to FDA no later than 30 days
after marketing a dietary supplement that either
makes structure/function claims on labels or in
labelling that includes the text of the structure/
function claim.
FOODS
Foods sold in the United States require a nutrition facts panel
on packaging, allergen statements and optional nutrient claims.
Health claims may be allowed as well.
Review your Dietary Supplement formula, provide
detailed feedback and engage in open discussion
with you to determine if there are any ingredients
that were not sold prior to DSHEA commencement
in 1994 (which may require a new dietary ingredient
notification).
Check for any ingredients that are part of
California’s Proposition 65 and advise you on label
compliance warning statements.
Substantiate structure-function claims.
Review your packaging for claims and FTC
advertising compliance.
OUR SOLUTION:
Assess your food to determine the nutrient content
claims, health claims, qualified health claims or
structure/function claims that could be used.
Determine if there are any new food additives in
your product and, if so, submit a food additive
petition.
Create a nutrition facts panel for your food.
OUR SOLUTION:

6. 1.800.396.5144
www.qualitysmartsolutions.com
info@qualitysmartsolutions.com
Dietary Supplements
• Formula label review
•
FDA notification for a dietary supplement
making structure/function claims
• New Dietary Ingredient notification
Food
•
Label review for nutrient health claim
substantiation
• Generally Regarded as Safe (GRAS) Notice
• Food Additive petition
• Nutrition Facts panel creation
Cosmetic
•
Cosmetic Product Ingredient Statements
(CPIS) submission
USA REGULATORY
SOLUTIONS
USA Regulatory
Solutions
COSMETICS
Reporting cosmetics in the United States is voluntary. It is called
the Voluntary Cosmetic Registration Program (VCRP). There are
two parts to the program. First is registering the manufacturing
and/or packaging establishments. Second is filing a cosmetic
product ingredient statements (CPIS). You may participate in
both programs or just one.
Complete a Form FDA 2511 for each facility location
Fill out a separate Form FDA 2512 for each
formulation.
OUR SOLUTION:

7. CANADA REGULATORY SOLUTIONS
Quality Smart Solutions is your ideal partner for
Canadian Regulatory Compliance.
NATURAL HEALTH PRODUCTS
Two requirements must be met in order to legally sell your dietary
supplement in Canada. A Natural Product Number (NPN) must be obtained from Health Canada and,
if you are based outside Canada, you must work with a Canadian licensed importer. First, a product
license application with the necessary supporting documentation (depending on the classification of the
product) is submitted to the Natural Health Products Directorate (NHPD, a division of Health Canada).
If the product is acceptable to NHPD, a NPN
license is issued in 10 days to 6 months
depending on the risk classification of your
product. The application is assessed based
on the safety and efficacy of the product for
the Canadian marketplace. Secondly, if the
product is made outside of Canada you must
utilize a NHP licensed importer in Canada.
The licensed importer must follow current
Good Manufacturing Practices (cGMPs) to
import NHPs and your manufacturer must also
demonstrate the same.
FOODS
Foods sold in Canada typically require a nutrition facts panel on packaging, allergen statements, optional
nutrient claims and bilingual labelling. However, certain food categories such as fortified or functional
foods may require special regulatory assessment before they can be sold on the Canadian market.
These include:
•
Temporary Market Authorization License - certain foods fortified with vitamins, minerals, amino acids
and/or caffeine
•
Novel Food Notification - foods that are from a new species,
food source or not traditional in Canada
•
Food Additive - an ingredient or chemical substance used in
preparing or storing a food and may become part of the food
during food manufacturing. These often have a purpose of
achieving a certain technical effect.
Review your product formula, provide detailed
feedback, and have open and engaging discussions
with you to ensure success in license issuance.
Prepare your Product License application and send
a full copy of the application package for your
review prior to submission.
Submit your Product License Application to Health
Canada and follow this through to license issuance.
Legally import your Natural Health Products into
Canada. Quality Smart Solutions can provide this
service as a licensed Canadian importer.
OUR SOLUTION:
Review cosmetic formula to ensure
any ingredient present in the product
is not on the cosmetic hot list.
Review label for cosmetic regulatory
compliance.
Submit cosmetic notification to
Health Canada.
OUR SOLUTION:

8. Natural Health Products
• Natural Product Number License (NPN)
• New Ingredient Submission (NHPID)
•
Natural Health Product Master File
(NHP-MF)
• NHP Importation
•
Site License submission (Canadian
companies only)
•
Label, Advertising NHP compliance review
and French Translation
Veterinary Natural Health Products
•
Low Risk Veterinary Health Product
submission (LRVHP)
•
Label and advertising LRVHP compliance
review
Food
•
Temporary Market Authorization License
(TMAL)
• Novel Food notification
• Food Additive submission
• Health claim substantiation
•
Label food compliance review, Nutrition
Facts panel creation French Translation
Cosmetic
• Cosmetic notification
• Hotlist ingredient review
• Label advertising cosmetic
compliance review
Drug
• Over-the-counter (OTC) drug submissions
• Establishment license application
1.800.396.5144
www.qualitysmartsolutions.com
info@qualitysmartsolutions.com
COSMETICS
The sale of a cosmetic in Canada requires that a
notification be submitted to Health Canada within
the first 10 days the cosmetic is for sale.
DRUGS
Over-the-counter (OTC) drugs require a Drug Identification
Number (DIN) prior to being sold in Canada. Fees are
associated with DIN submissions depending on their category.
Licenses are issued by Health Canada within a reasonable time
period. If you are a foreign manufacturer you are required to
partner with a Canadian licensed drug importer.
Review cosmetic formula to ensure any ingredient
present in the product is not on the cosmetic hot list.
Review label for cosmetic regulatory compliance.
Submit cosmetic notification to Health Canada.
OUR SOLUTION:
Review your formula to ensure it
meets the OTC drug monograph
requirements
Prepare a DIN application and
submit to Health Canada
OUR SOLUTION:
Canadian Regulatory
Solutions
CANADIAN REGULATORY
SOLUTIONS