Pre-Market Regulatory Submission

Regulatory submissions are critical components of the regulatory process for both government and industry. Students work with industry to complete a regulatory submission from one of the following areas: pharmaceuticals, medical devices, biotechnology, natural health products, agrochemicals, and/or industrial chemicals. Students delineate the appropriate sequence and processes required for new product approval, including the selection of appropriate guidance documents.      

Note: Check with the institution regarding start/end dates, prices, and delivery method. These may vary according to program, section, and/or semester.