The core business of TPIreg provides regulatory support to innovative and subsequent entry clients for Canadian pharmaceuticals and biotechnology. Our team of experts can deliver services from staffing support to expert advice for all your Canadian regulatory needs, including:

  • Regulatory Assessments, Gap Analyses and Due Diligence
  • Pre-submission Meetings
  • Product Monograph and Labelling Development
  • Clinical Trial Applications, and Canadian CTA agent
  • New Drug Submissions (NDS)
  • Supplemental New Drug Submissions (SNDS)
  • Abbreviated New Drug Submissions (ANDS)
  • Drug Identification Number Submissions (DINs)
  • Post-Market filings
  • eCTD and electronic format and filings
  • Rx to OTC switches
  • Biowaiver requests
  • Regulatory Training and SOP development

To find out more about how our team at TPIreg can help you, please call us at 905-690-4343 or email us at .

Therapeutic Products Inc. (TPIreg) – a boutique Canadian consulting firm offering regulatory and quality assurance services to the pharmaceutical and healthcare industry in North America.