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

  • Regulatory Assessments, Gap Analyses and Due Diligence
  • FDA Meetings
  • Prescribing Information and Labelling Development
  • New Drug Applications (NDA)
  • Abbreviated New Drug Application (ANDA)
  • Office of Prescription Drug Promotion (OPDP) filings
  • Post-Market filings
  • eCTD format and filings
  • Regulatory Training and SOP development
  • Biowaiver requests

To find out more about how our team at TPIreg can help you, please call us at 905-847-4310 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.