1st Quarterly Update 2011

After receiving the marketing authorization in late 2010 we have this quarter started the importation of a medicinal product from the USA for which we act both as the EU marketing authorization holder and as EU import and release site. Actually it is not us, but our sister company Baggerman FarmaNet who is the legal entity holding these responsibilities. This structure enables us to service non-EU pharmaceutical companies and to provide these with EU market access for their medicinal products. Currently we have a second non-EU client from Asia who is interested in this possibility and may join us in the future. Just have a look at www.farmanet.nl if you want more info on this subject.

But not only import from licensed medicinal products from outside the EU was on our table this quarter, we had another client who is interested in setting up a compassionate use program for unlicensed non-EU pharmaceuticals for Dutch patients. Discussions are now ongoing with our logistic service provider regarding the cost structure of such a service. This cost structure is of paramount importance as the limited number of patients who will be using these medicines contrasts sharply with the import of authorized medicinal products as described above.

Apart from these special projects we also had a number of “regular” QA and RA projects coming in recently:
• An extensive CAPA & Deficiency Remediation project with a major Dutch manufacturing site
• Interim Benelux Regulatory Affairs & Pharmacovigilance management for yet another Dutch manufacturing site
• The GDP licensing of two different distribution sites for OTC medicinal products
This endless stream of regular projects is an important “performance indicator” for our company which proves that new clients somehow succeed in identifying us as a service provider, while existing clients show a continued trust in the quality of our services.