Health Canada Compliance Solution | FDA Compliance Solution

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. THE QUALITY SMART DIFFERENCE: Personal Touch, Client-Centric Service. Still not enough reasons? Here are 10 more! 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.

2. 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@qualitysmartsolutions.com

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. 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

4. FOREIGN (NON-CANADIAN) COMPANY REQUIREMENTS TO EXPORT THROUGH QUALITY 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. 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@qualitysmartsolutions.com

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. 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 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. 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.

6. 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@qualitysmartsolutions.com

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. 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.

8. 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. 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. 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 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 CANADIAN REGULATORY SOLUTIONS 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 Cosmetic • Cosmetic notification • Hotlist ingredient review • Label & advertising cosmetic compliance review Drug • Low Risk Veterinary Health Product submission (LRVHP) • Label and advertising LRVHP compliance review • Over-the-counter (OTC) drug submissions • Establishment license application Canadian Regulatory Solutions 1.800.396.5144 www.qualitysmartsolutions.com info@qualitysmartsolutions.com