CLINICAL SUPPLIES

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3rd - 6th MAY 2010
BIO 2010 CHICAGO - USA

LAST NEWS
Nov 2009 - DSM/Galenix strategic alliance

Galenix out-licenses drug delivery technologies to DSM Pharmaceutical Products and forms in a strategic alliance : Galenix today announced that it has out-licensed six drug delivery technologies to DSM Pharmaceutical Products, Parsippany, USA. Galenix and DSM have also agreed on a manufacturing alliance, where DSM will be the preferred commercial scale manufacturing partner for Galenix commercial products on a global basis. Galenix and DSM will collaborate on business development opportunities co-marketing the technologies based on the strength of Galenix in drug product development and clinical services, and DSM in process development, industrial scale up and commercial pharmaceutical manufacturing.
2009 - cGMP Agreement for human use

Galenix Pharma has obtained an updated agreement for cGMP manufacturing, importation and ditribution of human and investigational medicinal products AFSSAPS #M09/168
2008 - cGMP Agreement for veterinary use

Galenix Pharma has obtained an agreement for cGMP manufacturing, importation and distribution of veterinary and investigational medicinal products AFSSA #V1515/08

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Primary packaging :

- Blisters (PVC-ALU, PVC-PVDC-ALU, ALU-ALU, etc...)
- HDPE bottles
- Glass vials


Labelling :

- Multi-lingual labels design and printing, boolklet labels, code-break enveloppes, randomization list


Patient Kits :

- Blister-cards design suitable for ambulatory clinical trials
- Patient kits design in accordance with the study protocol
- Kits labeling and assembly


Distribution :

- Clinical Trials Units shipment to Europe and Worldwide
- Room and controlled temperature (+2 +8°C)
- Carrier selection according to several criterias (delivery place, quantity, deadlines, storage conditions, nature of the products)
- Returns
Primary pckaging
Galenix GMP facilities
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