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ADVERSE REACTION REPORTING

Adverse Reaction Reporting on the part of product licence holder is mandatory in Canada for both natural health products (NHPs) and drugs. Many companies do not have the in-house expertise to fulfill this obligation. MEDERA has both the scientific expertise and the regulatory expertise.

Our services in this area include:

  • Adverse reaction evaluation and classification
  • Preparation of adverse reaction case reports
  • Preparation of adverse reaction annual summary reports for Health Canada and the Marketed Health Products Directorate (MHPD)
  • Guidance on how, when, and where to submit serious adverse event reports
  • Record maintenance for serious and non-serious adverse events
  • Preparation and submission of FDA Form 3500A

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

Contact us to find out more about our regulatory consulting services or to receive a free copy of our white paper on marketing a healthcare product in Canada, click here.