QA and 3PL licences: Helping you stay compliant

Transcript of 'QA and 3PL licences: Helping you stay compliant'

 

What licences does Innomar Strategies hold for QA and 3PL services?

We have various licences that have been approved by Health Canada. That includes a Drug Establishment Licence for which we're authorized to import, wholesale, and conduct repackaging or relabelling activities for drug products. We also have a Medical Device Establishment Licence that authorizes us to import and distribute classes one to four medical devices, natural health products Site Licence that allows us to import and label natural health products. We also have a narcotic and controlled substance Dealer’s Licence.

Now what this means is Health Canada has reviewed our systems and really found that they are compliant with regulations to be able to effectively manage those products that we have licences for. Examples of those systems that we may have in place are training, deviation management, material management, internal audits, CAPAs, and change management controls in place. On top of that we also conduct Importer of Record activities. What that really is, Health Canada is looking to us to verify the terms and conditions with the product has been approved for use by Health Canada is being met before release for distribution. Some of those incremental tasks are review and maintenance of specifications, master manufacturing records, stability data, testing, and in addition, we need to conduct annual product quality reviews on those products. With the licences that we have and the services that we can provide, we are effectively a one-stop-shop for our clients. Rather than our clients having managed multiple vendors, they can just come to us to fulfill all their needs and really facilitate their distribution of their product.