Regulatory affairs services for Canadian companies supported by NRC IRAP

Since 2019, the CRBM and NRC IRAP have been working together to provide Canadian SMEs regulatory affairs assistance via interactive visits. The results of these interactive visits, presented in a report, help identify regulatory needs and ensure real alignment of the company with its market. In short, these studies allow us to identify and understand the production stages in the light of current regulations and to promote product approval by addressing regulatory issues.

Consultation of various Canadian, American and international life sciences databases, combined with our team's expertise and experience in data collection and information processing, lead to recommendations for positioning the product developed by the company.

Some of our achievements:

• Support for the approval of various products
• Revision of elements in regulatory submissions filed with Health Canada
• Commercialization processes (cosmetics, NHPs, sunscreens, medical devices, animal health products, etc.)
• Classification of products according to application regulations (e.g., disinfectants, sanitizers)
• Regulatory audit preparation and response
• Development and completion of analyses required for the submission
• Preparation of an analysis plan for the submission
• Preliminary microbiological and chemical analyses
• Combination of regulatory support and market intelligence services with a specialized consultant

We provide companies with comprehensive support thanks to our deep understanding of current regulations, forward-looking approach to industry changes, and expertise in regulatory mechanisms.