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.

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This quarter we celebrated the 20th anniversary of our company by spending a marvellous weekend in Istanbul with all team members and their partners. We enjoyed the views from a boat trip on the Bosporus and paid visits to most of the famous architectural beauties of this city. Turkish hospitality provided for lots of good food in various nice restaurants in the city and of course we paid a visit to the Grand Bazaar where some of us spent money on “nice things to have” or got chased by stallholders in case they didn’t. But as all things must come to an end we returned home to find out that it is again “business as usual”.

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“Risks first” is the title of the 2007 Work Program of the Dutch Pharmaceutical Inspectorate which reflects the new approach to give priority to those developments and products with the highest risk impact for society. Four priority areas have been identified with related activities to be performed in 2007. Quite surprisingly, one of these priorities refers to the large-scale production of pharmaceuticals in hospital pharmacies although the risk impact of this production by no means has been substantiated by the Inspectorate. Nevertheless, this will have significant impact for our agency as 30 hospital pharmacies are to be audited this year. I wonder how many of those will subsequently call in our support for the implementation or upgrading of their  Good Manufacturing Practices. Already two of them did last month and no doubt more will follow in the course of this year.

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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.

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Release procedures for medicinal products, requiring the intervention of a Qualified Person, may present problems to pharmaceutical companies. In particular those companies manufacturing quite a number of small batches per day and over a period extending the usual office hours, will face troubles in having a QP stand-by at any moment to sign-off the release documents. One of these companies now has called in our help to restructure the release procedure to solve this problem. The solution will include modifications of the release documentation as well as IT-structures to simplify document traffic between the manufacturing site and the various QP’s responsible for final product release. We expect to get this system up and running in Q4 and we hope that this system will “release” this company from a growing annoyance.

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Investigational medicinal products (IMP’s) are on the agenda these months as we are to take care of the regulatory details of two such products. For an ophthalmological product we are co-writing parts of the Investigational Medicinal Product Dossier (IMPD). A second project includes a new radiopharmaceutical compound for which we have to comment on the supply chain. In addition we will support the manufacturing company with the application for a pharmaceutical manufacturing license. As you may know, IMP’s are subject to GMP-regulations as much as regular medicinal products, requiring such a license as well as the appointment of a Qualified Person to release the batches.

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This quarter our team had to pull out all the stops to support a Top-10 pharmaceutical company who suffered unexpected and extensive vacancies at the RA – department. Not less than 4 of our team members had to devote some part of their time each week to take over some of the ongoing projects. Never before we have provided such massive support to one of our clients but we are glad we’ve made it and released this client from a major problem. In the meantime new staff has been hired by the company and in April our business will be back to normal and we will again have some time available for other clients. So if you ever considered calling upon us, this is your moment…..

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