4th Quarterly Update 2006
This quarter we received an unusual number of requests for the preparation of preclinical overviews, clinical overviews and clinical justifications for new indications. As these are time consuming projects for which only limited capacity is available within our team, a strict planning, extending to mid-2007, will be necessary to devote the required attention to these projects. Some of these requests refer to rather old compounds for which regular literature searches will fail as pivotal studies date back to the early sixties and sometimes fifties. So goodbye to PubMed and welcome to a process of “stringing beads” in which one article leads to another.
The merger of two pharmaceutical companies will inevitably lead to a renewal of wholesale and manufacturing licenses if it were not only for a name change of the licenses. Such renewal sometimes reveals major regulatory deficiencies when these companies have not been audited by the Inspectorate for a number of years. And this was the case with a merger where we were called in for help with these deficiencies. We designed a project plan to eliminate these non-compliances, we will adapt the Quality Manual accordingly, we will revise existing contract manufacturing agreements and we will deliver Qualified Person services for an interim period.
On the European level we have started to support an American pharmaceutical company with the set-up of a European subsidiary. This subsidiary will distribute pharmaceuticals throughout Europe from a distribution center based in the Netherlands. We will take care of the licensing process, will implement the relevant GMP and GDP items into the quality system of this company, and we will again act as interim Qualified Person until a full-time employee will be hired for this purpose. These projects usually demonstrate a strong interference of regulatory, fiscal and logistic preconditions and the ultimate business-model of such a subsidiary will have to provide for a stable compounding of these ingredients, while at the same time full regulatory compliance to the relevant legal requirements of each domain related to these preconditions will be necessary.
The number of pharmaceutical companies requesting support for their regulatory affairs departments increased steadily during the last years. The processing of a MRP with the Netherlands as RMS for a German company, a reimbursement application for an Italian company or an OTC switch for a Belgian company are some examples of foreign companies which did so during this quarter. On the national level one of our colleagues will be supporting a Top-5 pharmaceutical company intensively for a 6 months period. Surely there will be moments where you could use similar support for your company in the future and when that happens, why not give us a try? You would be surprised how many competitors of yours we already have come to know…..
