This year’s BIOFINE in Freiburg was a home match for ChemCon. We presented our contract research and manufacturing services as an exhibitor, in collaboration with other partners from Biovalley (a regional, trinational cluster of pharma and biotech companies). There were plenty of opportunities for networking with complementary companies and discuss future business development as well as matters of common interest.

A major strength of BIOFINE is bridging the gap between commercial companie

ChemCon´s Quality Control department is approved by the German Health Authorities (Regierungspräsidium), AMG (§ 14 Abs. 4 Nr. 3) to perform release testing of finished pharmaceuticals. This includes our state of the art NMR instrument (Bruker UltraShield), which is, like the other equipment, fully qualified for cGMP release. The responsible NMR QC operators are highly trained and experienced with the creation of the necessary GMP documentation and the requirements of the

APIs and Excipients: EU-GMP-Legislation

On October 30th, 2005 a new EU legislation came into force that could be of utmost importance for the European manufacturers of active pharmaceutical ingredients (APIs). Directive 2004/27/EC, amending directive 2001/83/EC, requires for all APIs in medicines that they must be manufactured according the GMP guidelines as defined by ICH-Q7A.....

As a consequence of the EU Directive 2004/27/EC, amending directive 2001/83/EC, which requires for all APIs in medicines that they must be manufactured according to the GMP guidelines as defined by ICH-Q7A, Germany executed the 14.......