2nd Quarterly Update 2008

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. It also includes support with respect to the necessary licenses for manufacturing and/or distribution.

Other pre-marketing elements of this program include supply chain design and pricing & reimbursement, while post-approval elements are pharmacovigilance and compliance-control of advertising and promotional materials. Already three overseas companies are participating in such programs and take advantage of the wide areas of experience as present within our team. Contact us if you are also interested in any of these elements or in the full program for your products or company.

Quite a number of new interim-positions in Big Pharma companies were to be filled this quarter including Qualified Person responsibilities in two of these and a Regulatory Affairs Manager position in a third one. Not rarely such positions initially only concern a couple of months of support, but once our consultants have been there for a while and have got thoroughly familiar with the company, they may got asked to stay on for a while for additional support. Such as the execution of projects piling on desks for months or years. A typical example of such additional support concerns a CAPA Investigational Project in a major biotech company aimed at the finalization of quite a number of long-time unresolved CAPA’s.

In the regulatory domain the final preparation of a Mutual Recognition Procedure for a generic has materialized and the submission of the file in the various member states will be due this summer. Not many projects like this one are to be expected until 2010 as all major European Medicines Evaluation Boards are fully booked until 2010 for Decentralized Procedures (DCPs) requiring all their capacity to support these DCPs. As a consequence, only limited capacity remains for national procedures including those preceding a Mutual Recognition Procedure. However, such practising of patience is hardly compatible with the highly competitive generic market where the quickest launch of new generics is pivotal for the eventual market share.