Has anyone had experience with exporting gene therapy IP from US to Canada? The sponsor doesn’t have local presence in Canada. The CRO stated they will not be able to assume the role as IOR or Canadian Agent due to nature of the organism of gene therapy IP as it carries an “unknown environmental risk”. The extra application with gene therapy products is the New Substance Notification application which requires a sign off as well. I have come across information on the sponsor being a non-resident importer and wondering if anyone has experience with this.