Being a Canadian Company, we are proud of our collective experience with all Directorates at Health Canada.  Our services include:

  • Gap Analysis
  • Label and advertising review for compliance
  • Post-marketing Management
  • Product review and feasibility
  • Publishing
  • Ongoing product support
  • Strategic Regulatory Advice
  • Training and courses
  • Regulatory Submissions

Regulatory Submissions:

  • Clinical Trial Applications/Investigation New Drug Submissions
  • Cosmetic Notifications
  • Drug Establishment License Applications
  • Drug Identification Number Submissions (DINs)
  • Medical Device Applications/Premarket Notifications 510(k), Premarket Approvals (PMA)
  • Natural Health Product License Applications (PLAs)
  • New Drug Submissions (NDS)
  • Abbreviated New Drug Submissions (ANDS)
  • New Drug Applications (NDA)
  • Abbreviated New Drug Application (ANDA)
  • Post market filings
  • Rx to OTC switches