MCS Associates has 25 Years Experience in all aspects of Regulatory Affairs with specific Health Canada compliance expertise
Practical experience in the Canadian marketplace will help speed your products to market.
Increasing Government regulation often means more obstacles between you and your market. MCS Associates Inc. provides both expert advice to help register products with appropriate government departments in Health Canada and Quality programs to help manage manufacturing, packaging, labeling, importation and distribution activities.
With 25 years of regulatory experience MCS can be a competitive advantage in both the Canadian and U.S. marketplaces.
Regulatory Compliance can be a challenging goal. Governments are continually enacting legislation that directly impacts your ability to do business.
MCS accredited experts inform proactively and not reactively with an action plan about the regulatory decisions that have positive influence on your business operations.MCS accredited experts conduct on-site qualified audits accepted by Health Canada to ensure that all steps in your manufacturing and operating practices, meet strict Good Manufacturing Practices (GMP).
MCS Associates can efficiently handle the entire product registration process on your behalf.
Practical experience in the Canadian marketplace can help MCS speed your products to market.
- MCS Associates has comprehensive Product License Applications (PLA) submissions, which are generally divided into four categories, experience and can help you to obtain NPN numbers without wasting time and money. Each class of product has different requirements in terms of the information to be submitted at the time of review, and MCS will help you every step of the way.
- MCS Associates has extensive DIN submissions experience and can help you review, amend or create your product’s labeling.
- We also conduct Ingredient Reviews for new cosmetic products entering the Canadian market from compliance perspective and file Cosmetic Notifications.
- With retail food products, MCS takes on regulatory consulting projects such as the development of new formulations for a successful market launch or improvement of existing formulations.
Operational Site LicensesOperational 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. Operational Licenses are only granted if the firm meets the GMP guidelines.
GMP addresses Quality Assurance, Accredited Personnel, Operations, Sanitation and Cleaning programs, Equipment & Premises, Product Specifications, Samples, Stability, Records, Recall Reporting, and Sterile Products.
MCS Associates Inc. consultants work with your company to design a GMP program for each facility based on operational activities. MCS will develop corresponding training programs for your staff to ensure that the program is properly implemented.
MCS Associates helps Importers and Exporters conform to Canadian health product regulations.
- 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
meet all requirements set by
Health Canada, speeding
your products to market.