ADVERSE EVENT REPORTING & PHARMACOVIGILANCE CONSULTING

The appropriate monitoring and reporting of adverse events is a requirement for dietary supplements and drugs in the United States (Adverse Event Reporting) and a requirement for natural health products and drugs in Canada (Adverse Reaction Reporting).

Many companies do not have the in-house expertise to properly assess and classify adverse events and may not keep appropriate records to fulfill these reporting obligations. With our own in house medical doctor and regulatory staff we have both the scientific and regulatory expertise to assist you in this area.

Adverse Event Reporting (AER) Services for the United States

  • Adverse event evaluation and classification
  • Guidance on how, when, and where to submit FDA Form 3500 and 3500A
  • Preparation of adverse event case reports
  • Record maintenance for serious and non-serious adverse events
  • Procedure creation for Call Center Representatives on handling calls completing AER forms
  • Training for Call Center Representatives on handling calls and completing AER forms
  • Creation of templates for Customer Complaints

Adverse Reaction Reporting Services for Canada

  • 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
  • Procedure creation for Call Center Representatives on handling calls completing AER forms
  • Training for Call Center Representatives on handling calls and completing AER forms
  • Creation of templates for Customer Complaints