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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Q4 2012 EU Cosmetics Regulation

This quarter has been the age of cosmetics as the upcoming new EU Cosmetics Regulation gets its grip on manufacturers and importers wanting to market their products in the EU. Various meetings currently deal with these issues and we were invited to two of those meetings to present our knowledge

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Q3 2012 MRP finalized

This surely was a “long time, no see” quarter as two previous clients from ages ago, twenty years to be more precise, now returned to us and called in our support for a second time around. One of these regards a pharmaceutical wholesaler with its main activities in international medical

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Q2 2012 GDS and CF pharmacies

Selling a marketing authorization from one company to another not only involves the transfer of money but also needs the transfer of regulatory files. Not an easy job when this is about old products which have been registered for decades and which have undergone massive variations throughout this period. And

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Q1 2012 25th anniversary of BFC

The end of this quarter marks our 25th anniversary as the company was founded April 1 1987. A lot of water has gone under the bridge since then but not all has been forgotten and some highlights of that period deserve attention at this memorable moment in time. During the

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