Regulatory Support

Regulatory affairs

We offer regulatory affairs assistance to:

Contribute to the development of formulated products and ingredients for regulated sectors, both in Canada and in different fields of application:
- Pharmaceuticals
- Medical instruments
- Biocides (surface disinfectants, hand sanitizers, UV disinfection, sanitizers)
- Natural health products (NHP)
- Cosmetics
- Functional foods (fortified foods, supplemented foods, novel foods)
- Cannabis products
- Veterinary drugs
- Veterinary health products (VHP) and animal feed

Complete the preparation of registration applications for active ingredients or formulated products.
Carry out activities related to the registration and maintenance of authorizations or other licences essential to the commercialization of various regulated products.

Quality assurance

We offer quality assurance support to guide you through the various stages of the following processes:

Laboratory accreditation.
Regulatory audits.
Drafting of procedures and other quality-related documents.

Accreditations

Health Canada drug establishment licence (DEL) - Test.
Public Health Agency of Canada Biosafety Permit - Containment Level 2 (CL2).
Facility certification - Recognition of Standards Council of Canada’s (SCC) Good Laboratory Practice (GLP) for disinfectant efficacy studies.

NRC IRAP Interactive Visit Program at the CRBM

The Interactive Visit Program provides eligible SMEs with up to 20 hours at the CRBM to identify their market-related regulatory needs. These visits allow Canadian SMEs to be guided and assessed in their progress on regulatory issues, with concrete solutions proposed. They can also include market intelligence services focused on regulatory aspects and validation of technical and analytical aspects, by proposing laboratory analyses.

Who is eligible?

Canadian start-ups or SMEs that:

Are seeking solutions to an innovation or regulatory challenge;
Want to assess their market potential in light of regulatory requirements;
Want to know their positioning in a specific market;
Need analytical results to validate aspects of their process.

What is the process?

Call NRC (toll free 1-877-994-4727) to be connected with the Industrial Technology Advisor (ITA) assigned to your region and describe your project. Alternatively, you can also call the CRBM to obtain assistance with this step.
Your ITA will review your project. If your project is accepted, you will be required to pay a file activation fee of $250 plus tax. All other costs will then covered by NRC IRAP.
Once your file is activated, you will be contacted by a CRBM expert who will have 90 days to address your project needs. According to the CRBM-NRC agreement, you will benefit from 20 hours of support which will allow you to have access to recommendations and concrete solutions promoting your innovation.

To learn more about some of the support services offered by CRBM experts, visit Regulatory Affairs Support Services for Canadian Companies Supported by NRC-IRAP section.

For more information, visit the National Research Council of Canada's (NRC) Industrial Research Assistance Program (IRAP) or contact us at [email protected].