Life Sciences / Adverse Event Reporting

Many companies lack the in-house expertise to assess and categorize adverse events and may not have kept the records needed to fulfil reporting obligations. Our team of medical doctors and regulatory consultants have the expertise you need to overcome any challenges you face in adverse event reporting management. 

 Adverse Event Reporting 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
• 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 event 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