QA consultants: Easing entry into the Canadian market
By Innomar Strategies
Market Access
A QA consultant can be a valuable resource when bringing a drug to the Canadian market. Hear from Brian Randall, Director, Quality Assurance, how QA consultants help you with critical steps from applying for a drug establishment licence to becoming your importer of record. With the experience of over 55 Health Canada inspections, our team has the expertise you can trust to guide you.
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Transcript of ‘QA consultants: Easing entry into the Canadian market’
What services do we provide as QA consultants?
So as a QA consultant, I provide advice and assistance to those people who don't have a Canadian presence, and they don't have a quality group who can do the work for them. So they bring us in to help them bring their product to market. One of the very first things you have to do is do a drug establishment license application, and that application is used in support of your regulatory filing. So once that drug application is in, your filing can get through screening. So at that point, then you have to really decide what kind of QA services do you need. We can become the Importer of Record, so we become your importer of record, which means we do all the main work so we're responsible to Health Canada. We talk to them if there's issues. We do the importation. We do the product release. We manage the complaints. We manage change control. We become your Quality Group. So you may have your own drug establishment license, so we can step in and be your quality unit, and then we can do all the quality stuff we would do if we were your importer, except we're doing it under your name. We have the experience of probably over 55 Health Canada inspections, which really gives us a huge benefit of understanding where inspectors see things, their different perspective on the regulations. And we can do all the work for you and do all the interaction with Health Canada on your behalf.
