Adverse Reaction Reporting

Get expert solutions from us in preparing FDA and Health Canada adverse reaction reporting that is complete and accurate.

What is Adverse Reaction Reporting?

Adverse Reaction reporting is mandatory in Canada and must be filed with Health Canada within 15 calendar days of receiving or becoming aware of the incident.  These can be submitted through fax, mail or by completing an online form. The success of Health Canada’s Adverse Reaction reporting system depends majorly on the completeness, quality, correctness and timelessness of the information submitted. Adverse drug reaction reporting may cause changes in decisions on regulatory actions such as withdrawal of a product from the Canadian market, health product effectiveness and imparting knowledge about health product safety that benefits all Canadians.

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Shams W.Pawel Amazing Grass

“We’ve worked with Andrew and the QSS team for 5 years and they’ve always been very knowledgeable and professional. They’re a tremendous partner to have when dealing with Health Canada compliance regulations and will always work with you to come up with the best solutions.”

Michael MT Consulting

I have been working with Andrew and his team at QSS for a couple of years now. I have clients from many different parts of the world and each situation requires expertise and focus, which I’m getting from QSS. I highly recommend Andrew and QSS to any perspective client who wants to “get it right” regarding Canadian and cross border compliance.

Donal Gauvreau Sapro

I've used QSS services for many years now and they always deliver a very professional service. Everyone on the team is great to work with and the always come up with great solutions for your needs at a great price!

    Why is Adverse Reaction Reporting Important?

    Healthcare relies primarily on the detection and reporting of suspected Adverse Drug Reporting or adverse reaction databases to identify new reactions and potential safety issues, detect factors that may increase risk, record the frequency with which they are reported and provide information to prescribers to prevent future ADRs. ADR is a method to improve health product safety for all Canadians. That’s why Health Canada has made adverse drug reaction reporting mandatory in Canada. 

    Risks and Benefits of Drugs

    Successful preparation and submission of ADR allow adding international data on the benefits, effectiveness or risks of drugs.

    Product Safety Information

    ADR enables Health Canada to provide and communicate changes in product safety information to industry, health care providers, hospitals, and consumers.

    Regulatory Actions

    Depending on ADR reporting, the agency may take regulatory actions, such as or removing a product from the Canadian market or change the product label.

    Other Benefits

    The Adverse reporting helps identify previously unrecognized, rare or serious adverse reactions or problems.

    Why should you use us for your Adverse Reaction Reporting?

    At Quality Smart Solutions, you will get assistance from former Health Canada and FDA Officials. They will guide you about ADRs and even assist you in Grade 4 Adverse drug reaction reporting. Moreover, we have 15 years of industry experience. We support in multiple languages to serve our global customers. You can connect with our live chat compliance expert anytime, anywhere.

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