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Regulatory Services

Among the many regulatory services we provide, are the following:
  • Regulatory strategy

  • Clinical study¬†submissions (CTAs and amendments)

  • Drug submissions (New Drug Submissions, Supplemental New Drug Submissions, Notifiable Changes) for pharmaceuticals and biologics

  • Co-ordinating and organizing pre-NDS or pre-CTA meetings with Health Canada

  • Medical device submissions

  • Natural Health Product submissions

  • Chemistry and manufacturing changes

  • Product monograph, package insert and package labelling development

  • Processing Access to Information (ATI) requests

  • Submission support during Health Canada review

  • Regulatory dossier assessment and review

We can also facilitate regulatory filings to the FDA in the United States and to the health authorities in Europe.

Please do not hesitate to contact us if you have any questions, or if you have other needs not included in the above list.