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Regulatory Affairs and Licensing

Your single point of contact to get compliant and stay compliant.

SERVICES →

Regulatory Affairs and Licensing

Your single point of contact to get compliant and stay compliant.

Practical experience and expertise to help speed your products to market.

MCS Associates has a long and successful history of providing regulatory leadership to companies with product registration and facility licensing for the development of new products and maintaining compliance to support existing products and sites. This includes the implementation of regulatory strategies, ensuring timely preparation, review and submission of documents to Canadian and international regulatory authorities.

Services and Solutions

  • Government Registrations (DIN/NPN/Medical Devices/OTC)
  • Site Licenses
  • Establishment License
  • Wholesale / Import / Distribute Licenses
  • Product Licenses
  • Product Classification & Registration
  • Label & Marketing Literature Review
  • Claims Substantiation

Applies to Edibles and Cannabis Health Products

Licensing Support
– Standard Cultivation & Micro-Cultivation
– Standard Processing & Micro-Processing
– Sale for Medical Purposes
– Analytical Testing
– Research
– Nursery

For additional Cannabis services, visit Cannabis and CBD

  • Medical Device Risk Classification
  • Medical Device Application
  • Fax Back Forms
  • License Annual Renewal
  • Establishment License/Annual Renewal
  • Health Claims Review

For additional services, visit Medical Devices

  • Food Safety/Compliance (HACCP/PCP)
  • Food Facility Registration
  • Nutritional Analysis / Nutrition Facts Table (NFT)
  • Temporary Market Authorization (TMA) (i.e. Energy Drinks)
  • Allergen Control Program

For additional services, visit Food and Beverages

  • Cosmetic Notifications
  • Cosmetic Formulation Ingredient Analysis

For additional services, visit Cosmetics and Personal Care

We provide in-house consultation expertise on Veterinary Health Products (VHPs) to Canadian Manufacturers, Importer, Distributors. VHPs are low risk drugs in dosage form and contain ingredients such as vitamins, minerals and traditional medicines. They are used to maintain or promote the health and welfare of companion and food-producing animals and are not for use to treat, prevent or cure disease.

Services include:

  1. Notification (i.e. obtain Notification Number)
  2. Review of the VHP labels
  3. Health Claims Review
  4. Act as a Representative in Canada [for importers]

Companies must notify Health Canada about their VHPs:

  1. At least 30 days before selling a VHP in Canada
  2. At least 30 days before making a change to a VHP that have been already notified
  3. Before importing a VHP into Canada

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