Adverse Reaction Reporting

Adverse Reaction Reporting on the part of product licence holder is mandatory in Canada for both natural health products and drugs, and are expected to become mandatory for foods and cosmetics in the future. Many companies do not have the in-house expertise to fulfill this obligation – dicentra has both the scientific and regulatory expertise to assist you in this area.

Our services in Adverse Reaction Reporting include:

  • Adverse reaction evaluation and classification
  • Guidance on how, when, and where to submit serious adverse reaction reports
  • Preparation of adverse reaction case reports
  • Preparation of adverse reaction annual summary reports for Health Canada and the Marketed Health Products Directorate (MHPD)
  • Record maintenance for serious and non-serious adverse reactions
  • SOP review and generation for Call Center Representatives on completing ARR form
  • Creation of templates for Customer Complaints (for ARR and/or quality complaints)

You can minimize your legal risks by having dicentra handle your adverse reaction reporting.