Regulatory Affairs

Canadian Regulatory Services

We provide regulatory services for submission of the following for HPFBI of Health Canada

  • Clinical Trial Applications (CTAs)
  • New Drug Submissions (NDSs)
  • Abbreviated New Drug Submissions (ANDSs)
  • DIN Applications
  • Notifiable Changes
  • Medical Device License Applications
  • Natural Health Product (NHP) Submissions

 

US Regulatory Services

We provide regulatory services for submission of the following for US FDA

  • Investigational New Drug (INDs) Applications
  • New Drug Applications (NDAs)
  • Abbreviated New Drug Applications (ANDAs)
  • Biologic License Applications (BLAs)
  • Orphan Drug Applications
  • Medical Device Applications (510k, PMA)