Health Canada Compliance Solution | FDA Compliance Solution

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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.
THE QUALITY SMART DIFFERENCE
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.
Still not enough reasons? Here are 10 more!
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SOLUTIONS FOR YOU
Regulatory Compliance (International)

• European Union (EFSA)
• United Kingdom (MHRA)
• Latin America
• Other Countries (check with us)

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

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

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

Solutions for you
1.800.396.5144 www.qualitysmartsolutions.com info_at_
qualitysmartsolutions.com
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CANADIAN IMPORT SOLUTIONS
Founded on quality, QUALITY IMPORT SOLUTIONS can
assist you with importation of health products,
storage, and third party logistics. IMPORTATION W
e are a Canadian licensed importer of natural
health products (NHP). We can bring licensed NHPs
into Canada from anywhere in the world.
OUR SOLUTION 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.
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
Food, Drug, Mass Supply Chain
Foreign (ie Outside Canada) Manufacturer
Importer (Quality Import Solutions)
Warehouse (annexed to QIS)
Warehouse from which FDM retailers draw from
FDM Retailer
Independent Channel Supply Chain
Foreign (ie Outside Canada) Manufacturer
Importer (Quality Import Solutions)
Warehouse (annexed to QIS)
Independent Retailer
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FOREIGN (NON-CANADIAN) COMPANY REQUIREMENTS TO
EXPORT THROUGH QUALITY IMPORT SOLUTIONS Manufact
uring 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.
CANADIAN IMPORT SOLUTIONS

• Dietary Supplements
• Product Review and Release
• Complaint and Adverse Reaction handling and
  investigation
• Storage and Logistics solutions
• Change Control

Your Canadian Import Solutions
1.800.396.5144 www.qualitysmartsolutions.com info_at_
qualitysmartsolutions.com
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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.

OUR SOLUTION 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 Californias
Proposition 65 and advise you on label
compliance warning statements. Substantiate
structure-function claims. Review your packaging
for claims and FTC advertising compliance.
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.
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.
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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.
OUR SOLUTION Complete a Form FDA 2511 for each
facility location Fill out a separate Form FDA
2512 for each formulation.
Food
USA REGULATORY SOLUTIONS

• Label review for nutrient health claim
  substantiation
• Generally Regarded as Safe (GRAS) Notice
• Food Additive petition
• Nutrition Facts panel creation

Dietary Supplements

• Formula label review
• FDA notification for a dietary supplement making
  structure/function claims
• New Dietary Ingredient notification

Cosmetic

• Cosmetic Product Ingredient Statements (CPIS)
  submission

USA Regulatory Solutions
1.800.396.5144 www.qualitysmartsolutions.com info_at_
qualitysmartsolutions.com
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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.
OUR SOLUTION 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.
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.

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.
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COSMETICS
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.
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.
OUR SOLUTION Review your formula to ensure it
meets the OTC drug monograph requirements Prepare
a DIN application and submit to Health Canada
CANADIAN REGULATORY SOLUTIONS
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

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

Cosmetic

• Cosmetic notification
• Hotlist ingredient review
• Label advertising cosmetic compliance review

Veterinary Natural Health Products
Drug

• Low Risk Veterinary Health Product submission
  (LRVHP)
• Label and advertising LRVHP compliance review
• Canadian Regulatory Solutions

• Over-the-counter (OTC) drug submissions
• Establishment license application

1.800.396.5144 www.qualitysmartsolutions.com info_at_
qualitysmartsolutions.com