News

Q4/15 To narco or to unnarco, that’s the ?

This quarter a new project came in requiring us to revive our long-sleeping narcotic license as we were requested to take on the distribution of a newly developed narcotic drug for the treatment of pain in the Netherlands. Contrary to non-narcotic medicinal products, such opioids cannot be distributed from a

Read the rest of the entry »

Q3/15 Freddy Mercury haunting my mind

We frequently travel to our clients in other parts of the world but never before in our history we had to visit Indian companies three times a quarter. One of these trips was about auditing two  manufacturing facilities of a client which are bound to launch their products on the

Read the rest of the entry »

Q2/15 The cotton is high

Quite a few licensing projects for wholesale and/or manufacturing companies we “harvested” this quarter. The most interesting ones include an on-the-border project where a facility will be situated right on the border, partly in Germany and partly in the Netherlands. Hmmmmm, what Inspectorate then will audit this facility? Another one

Read the rest of the entry »

Q1/15 Consultants & experts, cowboys & angels?

This quarter we welcomed our new colleague Maarten Bisseling who brings with him significant experience in the Pharmacovigilance domain. He has worked for 8 years as Pharmacovigilance Support Officer and Safety Data Specialist, subsequently in a company marketing generic medicines and a global company distributing innovator medicinal products. He represents

Read the rest of the entry »

Q4 2014 Two strikes out and a triple-trip

This last quarter of 2014 proved particularly productive as we finalized two rounds of questions related to separate marketing authorization applications, one for a centralized procedure and one of a decentralized procedure. The former is about to end in mid 2015 representing the end of a 4-year period of processing

Read the rest of the entry »

Q3 2014 Who guards the guardians?

Corporate audits required our attention this quarter or, to be more precise, the remediation of findings noted by corporate auditors.  Time and time again we get surprised by how high the level is raised by corporate auditors as compared to governmental Inspectorate auditors as we once more  noticed in two

Read the rest of the entry »

Q2 2014 Centralised Procedure

This quarter the long-awaited EMA comments on the marketing authorization application for  the centralized procedure which is handled by us came in. Not that bad after all with only  64 issues to be solved while the mean number of comments for  such procedures amounts to 200. Still quite a lot

Read the rest of the entry »

Q1 2014 Qualified Person hired

This quarter we welcomed our new colleague Jasper Vink who brings with him broad  experience with the manufacturing and quality control of radiopharmaceuticals including many years of Qualified Person responsibilities. This experience was obtained within a global manufacturing company and  included various multi-site QA harmonization projects. Jasper will add extensive

Read the rest of the entry »