CLINICAL SUPPLIES

meet us at
Oct. 25th - 27th - 2011
CPHI Frankfurt - Germany
March 12th - 15th - 2012
DCAT New York - USA

LAST NEWS
2011 - Certificate of GMP compliance of a Manufacturer for Human investigational medicinal product

2011 - Certificate of GMP compliance of a Manufacturer for Human medicinal product

MAA CESSION & TRANSFER
Licensing-out opportunity Cetirizine 10 mg/ml, oral solution (NL33352)
NEW MAA CESSION & TRANSFER
Licensing-out opportunity Donepezil 5 mg, ODT (NL37771) and Donepezil 10 mg, ODT (NL37772)
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
MAA CESSION & TRANSFER
Licensing-out opportunity Fenofibrate 67 mg, tablet (NL27271) - Fenofibrate 200 mg, tablet (NL27274) and Fenofibrate 160 mg, modified release tablet (NL31360)

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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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