This quarter, as well as the next one, a significant amount of our time will have to be devoted to the removal of our agency to new offices which expectedly will take place in July of this year. Our current location has been lodging us ever since 1990 and it
This quarter our Healthcare Inspectorate intensified its surveillance of the use of biocides (i.e. disinfectants) in hospitals. This is related to the implementation of the EU- Biocides Directive in our national law which included a grandfathering of all currently available disinfectants if these were applied for by 15 September. All
Building projects dominate our list of new projects this quarter as two companies requested our support for the construction of their pharmaceutical production laboratories. One of these concerns a facility for the production of radiopharmaceutical parenterals, requiring the careful integration of GMP requirements and radiological safety requirements. The other facility
This quarter two USA companies called for our support to initiate a clinical study in the Netherlands. While CRO’s usually are well-equipped to design and finalize the trial protocols, creating the appropriate supply chain to all investigational centers is quite a different story. Such a supply chain from the USA
Borderline issues frequently occupy our minds as an increasing number of pharmaceutical companies consider changing the regulatory status of their products from pharmaceuticals to medical devices. Not only the regulatory pathway leading to the final certification is by far the easiest for medical devices, also the requirements for proof of
This quarter we have become Council Partner of the Gerson Lehrman Group (www.glgroup.com). This group concerns a worldwide consulting management platform currently including over 200,000 experts covering quite a few business domains. We were invited to participate with the Healthcare Group thanks to our overall knowledge of, and experience with,
Medicinal gases required our thorough attention this quarter. These products were relatively late recognized as medicinal products, similar to radiopharmaceuticals which likewise were unregulated products before 1992. Only in recent years the first marketing authorizations for medicinal gases have been granted in NL, leading to the uncommon appearance of patient
This quarter we have intensified the development of our Market Access Program (MAP) which is meant for the support of non-EU customers who want to enter the Dutch and/or European market. Not only classical regulatory product support, related to the approval and maintenance of marketing authorizations, is part of this program.