Overview

Select MCS Associates as Your Canadian Regulatory Partner

MCS Associates and our affiliates can help you at all stages of the Product Development Cycle. This includes Scale Up Experiments to understand how the formulation behaves at the manufacturing plant level and Process Validation Studies (i.e. cleaning validation studies and finished product test & method validation).

MCS Regulatory Associates are with you every step of the way

MCS Associates takes the lead role by assisting with pre-market authorizations in the form of product licenses that must be filed with the government regulatory departments. Operational licenses must be in place in the form of establishment licenses or site licenses. If the product is being imported from a foreign-site manufacturer (outside of Canada), the foreign sites must provide GMP compliance evidence. MCS Associates ensures that your Quality Programs are appropriate for the Canadian Marketplace.


Product Development Cycle
  • Product Concept
  • Formulation
  • Product Registrations
  • Site Licensing
  • GMP Production
  • GMP Importing
  • Distribution
  • GMP Post Market Surveillance



As the regulated product enters the marketplace you have an obligation to monitor your product for adverse events, complaints and potential recalls. MCS Associates assists you with all aspects of post-market surveillance for exceptional Quality Assurance, in other words, we help you keep your business in compliance.



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MCS provides a wide range of Product Registration Consulting Services including:
  • Label development and review (Canadian & U.S.)
  • Formulation evaluation
  • Product registration
  • SOP Writing
  • GMP compliance audits for both domestic and foreign sites
  • Establishment /Site Licensing
  • Quality Control and Quality Assurance Programs

Go For the Gold
with MCS Associates!
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