News

Q4 2013 Qualified Person & e-Leaflets

This quarter we welcomed our new colleague Susil Chotoe who brings with him broad pharmaceutical manufacturing experience gained in subsequently biotech, solid oral dosage forms and packaging facilities. Susil will add extensive QP-capabilities to our team which was necessary to accommodate the increasing demands from our customers to provide them

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Q3 2013 New EU GDP Directive

This quarter the long awaited, new, EU Good Distribution Practice (GDP) Guideline came into force and one of the major new aspects of this guideline refers to the transportation of medicinal products. While previously such transportation was not on the radar of pharmaceutical inspectorates, it now certainly is. This has

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Q2 2013 Drug-device borderline

This quarter the processing of an unusually high number of license applications for pharmaceutical companies was started by our team, including 5 wholesale license applications and 1 manufacturing license application. Not all of these represent straightforward wholesaling or manufacturing companies as two of these are involved in complex European supply

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Q1 2013 PIP-waiver granted

This quarter marks the long awaited appearance of the new EU-Guideline for the Good Distribution Practices for medicinal products. Published on March 7 2013 , and subject to a 6-months transition period, this guideline will oblige all European pharmaceutical wholesalers and logistics service providers to adapt, or more precisely to

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