Monitoring Adverse Drug Reaction
Post-market monitoring of drugs (pharmacovigilance) is audited separately by Health Canada. This process encompasses not only quality team, but also sales, marketing and customer service teams: Any person that is in contact with a complaint relating to an adverse drug reaction has a part in in the process.
Atinza will ensure that client’s reports are prepared and submitted within the required timeframes and meet all Health Canada’s requirements.
Drug Recall
During a recall, Health Canada works closely with the recalling firm (which can be a manufacturer, importer, brand owner, or distributor) to ensure that the recall strategy and communication meet the minimum standards of communication.
Atinza will support clients to ensure that all affected customers are identified and notified promptly, and appropriate documentation is submitted to Health Canada on time to reduce clients’ losses and minimal disruption to client’s business.
Post marketing support
- In the case of recall or complain, Atinza can communicate with Health Canada on behalf of the clients and monitoring deadlines for the clients
- In the case of an out-of-specification result, complaint, or recall, Atinza will assess the risk and provide customized guidance to the clients, ensuring that the issue is handled efficiently and correctly.
- Communicate with Health Canada on behalf of clients.
- Guidance services
- Timely response to inquiries of Health Canada on behalf of the clients
- Communicate with suppliers and customers of clients to coordinate all correspondence and fulfill tractability requirements.