Q1/2016 Our license hattrick

With the receipt of our pharmaceutical wholesale license, this quarter marks the finalization of the logistic service concept of our company. With the presence of an import license, narcotic license and our newly obtained wholesale license we will be able to support any client who needs logistic support next to the standard  regulatory support  we have been offering since 1987. While the import license aims at non-EU clients, the wholesale license will be indispensable to support EU-clients and so next quarter we will start with the distribution of a narcotic medicinal product on behalf of an EU-based client.

Requests for such support come in at a regular basis and from various parts of the world, such as the Australian company who contacted us to export a medical device, manufactured in China, to the European Union. What better proof can you get to demonstrate the globalization of pharmaceutical and medical device supply chains?  Or would that be the European manufacturer of polyethylene terephtalate bottles who sells these bottles to a USA pharmaceutical company? And so we were asked to identify a contract laboratory which is able to demonstrate compliance of this bottle with the USP. Not quite an easy job as this USP-monograph requires a whole battery of analytical instruments, not routinely present at such contract laboratories.

Pharmacovigilance audits usually include us as the auditee as we perform vigilance services to quite some pharmaceutical companies. This then leads to the inevitable corporate auditors coming over to our premises to investigate our PV-systems. But this quarter we were asked to do it the other way around as we got invited to audit the corporate PV-system of one of our clients. So two members of our PV-team will do this job and we are interested how this different role suits them. Will they scarify the auditees as much as we got scarified by our corporate auditors?