3rd Quarterly Update 2007
Although the Netherlands have no shortage of pharmaceutical third party distributors, various European companies are convinced, probably on good grounds, that there still is ample room for expansion into this market. So, two requests came in this quarter to support such companies with the wholesale licence application as well as with the adaptation of their ISO-systems to comply with the European GDP-regulations for pharmaceuticals. A type of project very familiar to us as we have supported at least a handful of companies with such projects in recent years. And since some of those also requested us to stay on board as Qualified Person (QP) we sometimes experience difficulties to assign one of our consultants as QP to these new clients for the simple reason that we have strict policies not to serve as QP for two competing clients. Time will tell if we will be able to arrange such support this time again.
A large project again involving QP-capacity refers to the Investigational Medicinal Product Manufacturing Department of one of the major Dutch pharmaceutical companies. One of us will have to dive into batch manufacturing records of a wide variety of dosage forms in order to release the respective batches of this department for use in clinical studies. Solid experience with the manufacturing and quality control particulars of such dosage forms is necessary for this job and some of our team have this experience. It also helps that in our team “you’ll never walk alone”. Almost anytime there’s a colleague around with just the experience you’re lacking so a simple phone call then can save you an awful lot of time. If this has raised your interest and you’re wondering if this would be the ideal working environment for you? Why not simply give us a call
On the regulatory affairs front it is the season of transfers as if it were the European soccer league. One company has contacted us for a due diligence audit of a marketing authorization before the transfer, another company discovered it registration files to have got lost after the transfer and yet another company found out that only two months after the transfer they ran out of stock of the product involved without having arranged for a timely change in MA-holdership and contract manufacturing agreements. With these projects piling up it makes me think of that old movie “Ghostbusters”. If only we had a device similar to that with which they chased away the ghosts……I’m sure those clients would be eager to pay a huge price for its magic.
