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GMP Complaints and Adverse Drug Reactions

The Canadian Good Manufacturing Practices (GMP) require that you have established procedures in place for handling of complaints. If you sell drug products and you currently don’t have established procedures for these activities, then a DSA Quality Consultant can develop programs for you which meet these regulatory requirements.

If your firm does not have resources on staff to assist you with investigations into quality complaints, then a DSA Quality Consultant can provide you with this expertise. We can review complaints, spearhead the investigation into the complaints, either directly or by dealing with your fabricators, and then ensure that the complaint can be closed out and resolved.

DSA can help you develop protocols which delineate your responsibilities for adverse event reporting, if and when, adverse drug reactions occur. DSA can help you determine if specific cases meet the requirements for adverse drug reaction reporting and can prepare the filings on your behalf. We can also assist you with the investigation and advise you on whether or not your investigations are sufficient to meet regulatory expectation.

"I feel better knowing that we can rely on the experts at DSA to help us address technical issues and product complaints. Our clients hire us because we are experts in marketing. We hire you because you’re the experts at GMP."

-Ron
Principal